HL7.FHIR.US.SIRB\Adverse Non-Medical Event Questionnaire - TTL Representation

This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions
: Adverse Non-Medical Event Questionnaire - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:Questionnaire;
  fhir:nodeRole fhir:treeRoot;
  fhir:Resource.id [ fhir:value "sirb-nonmedicalevent-questionnaire"];
  fhir:Resource.meta [
     fhir:Meta.versionId [ fhir:value "9" ];
     fhir:Meta.lastUpdated [ fhir:value "2021-07-27T02:22:44.671+00:00"^^xsd:dateTime ];
     fhir:Meta.source [ fhir:value "#GxnTt2MWvknGBINg" ]
  ];
  fhir:DomainResource.text [
     fhir:Narrative.status [ fhir:value "generated" ];
     fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>Structure</b><table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;\"><tr style=\"border: 2px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top\"><th style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/formats.html#table\" title=\"The linkId for the item\">LinkId</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/formats.html#table\" title=\"Text for the item\">Text</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/formats.html#table\" title=\"Minimum and Maximum # of times the the itemcan appear in the instance\">Cardinality</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/formats.html#table\" title=\"The type of the item\">Type</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/formats.html#table\" title=\"Other attributes of the item\">Flags</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/formats.html#table\" title=\"Additional information about the item\">Description &amp; Constraints</a><span style=\"float: right\"><a href=\"http://hl7.org/fhir/R4/formats.html#table\" title=\"Legend for this format\"><img src=\"http://hl7.org/fhir/R4/help16.png\" alt=\"doco\" style=\"background-color: inherit\"/></a></span></th></tr><tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_q_root.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"QuestionnaireRoot\" class=\"hierarchy\"/> NonMedical_events</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Questionnaire</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Research Study</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> nme1.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Study Title:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme1.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Study Title from the Informed Consent</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> nme1.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">IRB Protocol Number:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme1.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">IRB Number from the Informed Consent</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme1.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Status:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.nme1.4\">4 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme1.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Status of study research activities</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme1.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If partial, please explain:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme1.5_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Explanation for voluntary hold on new participant enrollment.</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme2a</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Site/Organization</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme2a_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Location of Adverse Non-Medical Event</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme2a.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Organization/site where the Adverse Non-Medical Event occurred</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> nme2a.1.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Name of organization/site where the Adverse Non-Medical Event occurred</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> nme2a.1.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">City</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> nme2a.1.3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">State</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> nme2a.1.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Country</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme2a.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Organization/site which is recording the Adverse Non-Medical Event</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> nme2a.2.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Name of organization/site which is recording the Adverse Non-Medical Event</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> nme2a.2.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">City</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> nme2a.2.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">State</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> nme2a.2.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Country</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme2b</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Site Principal Investigator for the site where Adverse Non-Medical Event occurred</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme2b_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Site Principal Investigator responsible for the research study at the site where Adverse Non-Medical Event occurred</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> nme2b.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">First Name</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme2b.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">First or given name associated with the site PI</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> nme2b.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Last Name</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme2b.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Surname or family name associated with the  principal investigator</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> nme2b.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Suffix</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme2b.5_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the principal investigator's name</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> nme2b.6</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Degree(s)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme2b.6_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Professional and Academic degrees associated with the principal investigator</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> nme2b.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Phone:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme2b.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Phone number for site PI</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> nme2b.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Email:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme2b.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Email address for site PI</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Report</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Non-medical adverse event report</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> nme3.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Report Date:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date report is created</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme3.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Report Status</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.nme3.2\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator if report is the Initial report or follow-up report</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme3.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Check at least one of the following criteria:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Reason for uanticipated problem reporting</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-boolean.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Boolean\" class=\"hierarchy\"/> nme3.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">New information resulted in unexpected change in risks of the research.</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator if new information resulted in unexpected change in risks of research</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme3.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">New or increased risk</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> nme3.5.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.5.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date new or increased risk first documented</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> nme3.5.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date discovered:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.5.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date new or increased risk discovered</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme3.5.3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Description:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.5.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Description of new or increased risk</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-boolean.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Boolean\" class=\"hierarchy\"/> nme3.6</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Unanticipated Problem Involving Risk to Participants or Others</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.6_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator if problem Involved risk to participants or others</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme3.7</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Unanticipated Problem</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> nme3.7.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Event date:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.7.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date event occurred</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> nme3.7.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date event became aware to study team:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.7.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date site research team first became aware of unanticipated problem</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme3.7.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Event Summary:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.7.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Summary description of unanticipated problem</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme3.7.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was this event Unexpected?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.nme3.7.4\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.7.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator if unanticipated problem was unexpected</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme3.7.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If yes, please explain:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.7.5_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Explanation for why unanticipated problem was unexpected</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme3.7.6</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was this event Related or Possibly Related to participation in the research?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.nme3.7.6\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.7.6_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Unanticipated problem associated with participation in the research study</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme3.7.7</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If yes, please explain:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.7.7_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Explanation for why unanticipated problem is associated with participation in this research</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme3.7.8</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Does this event suggest that the research places participant(s) or others at a greater Risk of harm than was previously known?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.nme3.7.8\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.7.8_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator if unanticipated problem increased risk of harm to  participants</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme3.7.9</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If yes, please explain:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.7.9_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Explanation for why unanticipated problem is associated with increased risk of harm for research participants</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-boolean.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Boolean\" class=\"hierarchy\"/> nme3.8</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Protocol Deviation (accidental or unintentional)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.8_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator protocol  deviation was accidental or unintentional</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme3.9</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Protocol Deviation (Non-Compliance)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> nme3.9.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.9.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date non-compliance first identified</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> nme3.9.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date discovered:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.9.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date site research team first discovered non-compliance protocol deviation</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme3.9.3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Description:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.9.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Description of non-compliance protocol deviation</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme3.9.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Does the deviation involve any of the following? (Check all that apply)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.9.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Reason for protocol deviation</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-boolean.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Boolean\" class=\"hierarchy\"/> nme3.9.4.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Failure to obtain informed consent when IRB deemed required</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.9.4.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Informed consent not obtained when required by IRB</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-boolean.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Boolean\" class=\"hierarchy\"/> nme3.9.4.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Modifying the protocol without IRB approval, except to avoid hazard to participants</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.9.4.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Protocol modified without IRB approval</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-boolean.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Boolean\" class=\"hierarchy\"/> nme3.9.4.3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Conducting research prior to IRB approval, during an IRB suspension or after IRB approval ends</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.9.4.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Conducting research without IRB approval</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme3.9.4.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Please explain any Checked items:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.9.9.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Explanation for why protocol deviation category checked</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme3.9.5</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was the deviation a substantive change from the protocol adversely affecting any of the following? (Check all that apply)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-boolean.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Boolean\" class=\"hierarchy\"/> nme3.9.5.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">The rights, welfare, or safety of the participants</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-boolean.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Boolean\" class=\"hierarchy\"/> nme3.9.5.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">The integrity of the research area</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-boolean.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Boolean\" class=\"hierarchy\"/> nme3.9.5.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">The participants' willingness to continue participation</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme3.9.5.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Please explain any Checked items:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-boolean.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Boolean\" class=\"hierarchy\"/> nme3.10</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">A breach of Confidentiality</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.10_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator of breach of confidentiality</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme3.11</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Breach of Confidentiality</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> nme3.11.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date breach occurred</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.11.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date breach of confidentiality first documented</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> nme3.11.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date discovered:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.11.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date site study team discovered breach of confidentiality</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme3.11.3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Description:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.11.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Breach of confidentiality description</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.11_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator of breach of confidentiality</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-boolean.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Boolean\" class=\"hierarchy\"/> nme3.12</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Incarceration of a participant in a protocol not approved to enroll prisoners</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.12_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator of a study participant incarcerated when the protocol is not approved for prisoner enrollment</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme3.13</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Incarceration</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> nme3.13.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.13.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date site first documented participant incarceration.</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> nme3.13.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date incarceration was discovered:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.13.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Data site study team discovered patient incarceration</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme3.13.3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Description:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.13.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Description of patient incarceration</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-boolean.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Boolean\" class=\"hierarchy\"/> nme3.14</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team.</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.14_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator if participant complaint of unexpected risks was not resolved by study team. Complaint information is related to study site.</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme3.15</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Participant Complaint</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> nme3.15.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Complaint Date:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.15.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date site first documented participant unexpected risk complaint</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> nme3.15.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date received:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.15.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date site personnel first received participant unexpected risk complaint</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme3.15.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Description:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.15.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Description of participant unexpected risk complaint</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-boolean.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Boolean\" class=\"hierarchy\"/> nme3.16</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Other Type of Adverse Non-Medical Event</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.16_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator for other type of Adverse Non-Medical Event</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme3.17</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Other Type</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> nme3.17.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Event date:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.17.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date event occurred</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> nme3.17.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date study team became aware of event:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.17.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date site research team first became aware of the event</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme3.17.3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Event Summary:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.17.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Summary description of the event</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme3.17.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was this Adverse Non-Medical Event Unexpected?</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.nme3.17.4\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.17.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator if event was unexpected</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme3.17.5</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If yes, please explain:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.17.5_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Explanation for why event was unexpected</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme3.17.6</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was this event Related or Possibly Related to participation in the research?</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.nme3.17.6\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.17.6_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Adverse Non-Medical Event association with participation in the research study</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1001.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme3.17.7</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If yes, please explain:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme3.17.7_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Explanation for why the event is associated with participation in this research</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Reporting</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme4_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Reporting information to Sponsor and both relying and reviewing IRBs</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme4.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was the Sponsor notified?</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.nme4.1\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme4.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator if Sponsor was notified of non-medical adverse event</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> nme4.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Notification date:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme4.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date sponsor notified of non-medical adverse event</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme4.3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was the IRB notified?</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.nme4.3\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme4.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator if study site IRB notified of non-medical adverse event</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> nme4.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Notification date:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme4.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date study site IRB notified of non-medical adverse event</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme4.5</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Were any Other Parties notified?</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.nme4.5\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme4.5_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Other parties notified of non-medical adverse event (such as coordinating center, other study sites, FDA)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme4.6</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Please list other notified parties</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Corrective and Preventative Action Plan</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme5_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Description of corrective and preventative action plan</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme5.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was a Root Cause analysis performed?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.nme5.1\">3 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme5.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicataor if analysis of underlying causes or problems that led to the non-medical adverse event was performed</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme5.2a</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If yes, provide determination:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme5.2a_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Description of what the root cause analysis determined the adverse event was caused by</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme5.2b</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If pending, describe status and interim findings, if any:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme5.2b_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Describe status and any interim findings of the root cause analysis</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme5.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was Corrective Action implemented?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.nme5.3\">3 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme5.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator if corrective action is implemented for non-medical adverse event</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme5.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If Corrective Action was implemented or is pending, provide a summary:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme5.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Summary of corrective action implemented for non-medical adverse event. If still pending, provide a status of the corrective action plan</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme5.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was Preventitive Action implemented?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.nme5.5\">3 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme5.5_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator if preventative action for non-medical adverse event is implemented</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme5.6</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If Preventitive Action was implemented or is pending, provide a summary:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme5.6_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Summary of preventative action implemented for non-medical adverse event. If still pending, provide status.</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme6</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Study Protocol and Informed Consent</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme6_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Description of protocol and informed consent changes</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme6.1a</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Are changes required to the Study Protocol as a result of this report?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.nme6.1a\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme6.1a_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator if changes are required in study protocol resulting from the non-medical adverse event report</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme6.1b</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Reason(s) why changes are not required in the Study Protocol:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: <br/>Options: <a href=\"#opt-item.nme6.1b\">3 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme6.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Justify your decision to not change the study protocol:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme6.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Justification for decision not to change study protocol based upon non-medical adverse event report</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme6.3a</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Are changes required to the Informed Consent as a result of this report?</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.nme6.3a\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme6.3a_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator if changes are required to the informed consent as a result of the non-medical adverse event report</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme6.3b</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Reason(s) why changes are not required in the Informed Consent:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: <br/>Options: <a href=\"#opt-item.nme6.3b\">3 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme6.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Justify your decision to not change the Informed Consent:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme6.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Justification for decision not to change informed consent based upon non-medical adverse event report</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> nme6.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Are notifications or re-consenting of participants required as a result of this change?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: <br/>Options: <a href=\"#opt-item.nme6.5\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme6.5_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator if notification or reconsenting of participants is required due to changes in Study Protocol or Informed Consent</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme6.6</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If yes, detail how the notification and/or re-consent will occur:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme6.6_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Description of how notification or re-consent will occur</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-text.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> nme6.7</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If no, justify your decision to not notify (re-consent) participants:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text\">text</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: </td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> nme6.7_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Rationale for not notifying (re-consenting) study participants</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> ADMIN00</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Administrative Use Only</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/extension-questionnaire-hidden.html\" title=\"Is a hidden item\"><img src=\"icon-qi-hidden.png\"/></a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> ADMIN01</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Link ID prefix</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/extension-questionnaire-hidden.html\" title=\"Is a hidden item\"><img src=\"icon-qi-hidden.png\"/></a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Initial Value: string = nme</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> ADMIN02</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/extension-questionnaire-hidden.html\" title=\"Is a hidden item\"><img src=\"icon-qi-hidden.png\"/></a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Initial Value: string = temporarily unavailable</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> ADMIN03</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">ID of the Research Study FHIR Resource associated with the study Questionnaire Responses</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/extension-questionnaire-hidden.html\" title=\"Is a hidden item\"><img src=\"icon-qi-hidden.png\"/></a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Initial Value: string = temporarily unavailable</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> ADMIN04</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Questionnaire Response ID of the local considerations Questionnaire Response, if any</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/extension-questionnaire-hidden.html\" title=\"Is a hidden item\"><img src=\"icon-qi-hidden.png\"/></a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr><td colspan=\"6\" class=\"hierarchy\"><br/><a href=\"http://hl7.org/fhir/R4/formats.html#table\" title=\"Legend for this format\"><img src=\"http://hl7.org/fhir/R4/help16.png\" alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format</a></td></tr></table><hr/><p><b>Option Sets</b></p><a name=\"opt-item.nme1.4\"> </a><p><b>Answer options for nme1.4</b></p><ul><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: nochange (&quot;No change in research activities&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: stopped (&quot;All research activities temporarily and voluntarily stopped for all participants&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: partial (&quot;Partial voluntary hold on some research activities for all participants (explain below)&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: hold (&quot;Voluntary hold on new participant enrollment only&quot;)</li></ul><a name=\"opt-item.nme3.2\"> </a><p><b>Answer options for nme3.2</b></p><ul><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: init (&quot;Initial&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: followup (&quot;Follow-up&quot;)</li></ul><a name=\"opt-item.nme3.7.4\"> </a><p><b>Answer options for nme3.7.4</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name=\"opt-item.nme3.7.6\"> </a><p><b>Answer options for nme3.7.6</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name=\"opt-item.nme3.7.8\"> </a><p><b>Answer options for nme3.7.8</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name=\"opt-item.nme3.17.4\"> </a><p><b>Answer options for nme3.17.4</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name=\"opt-item.nme3.17.6\"> </a><p><b>Answer options for nme3.17.6</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name=\"opt-item.nme4.1\"> </a><p><b>Answer options for nme4.1</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name=\"opt-item.nme4.3\"> </a><p><b>Answer options for nme4.3</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name=\"opt-item.nme4.5\"> </a><p><b>Answer options for nme4.5</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name=\"opt-item.nme5.1\"> </a><p><b>Answer options for nme5.1</b></p><ul><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: completed (&quot;Done, performed or completed&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: pending (&quot;Pending - Currently under development&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: notundertaken (&quot;Not done or undertaken&quot;)</li></ul><a name=\"opt-item.nme5.3\"> </a><p><b>Answer options for nme5.3</b></p><ul><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: completed (&quot;Done, performed or completed&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: pending (&quot;Pending - Currently under development&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: notundertaken (&quot;Not done or undertaken&quot;)</li></ul><a name=\"opt-item.nme5.5\"> </a><p><b>Answer options for nme5.5</b></p><ul><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: completed (&quot;Done, performed or completed&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: notundertaken (&quot;Not done or undertaken&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: pending (&quot;Pending - Currently under development&quot;)</li></ul><a name=\"opt-item.nme6.1a\"> </a><p><b>Answer options for nme6.1a</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name=\"opt-item.nme6.1b\"> </a><p><b>Answer options for nme6.1b</b></p><ul><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: mla (&quot;Adverse Non-Medical Event consisted of a missed lab or assessment by a participant (which does not jeopardize the study or increase risks to other participants)&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: mtd (&quot;Adverse Non-Medical Event consisted of a missed treatment or dose by a participant (which does not jeopardize the study or increase risks to other participants&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: otherreason (&quot;Other reason&quot;)</li></ul><a name=\"opt-item.nme6.3a\"> </a><p><b>Answer options for nme6.3a</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name=\"opt-item.nme6.3b\"> </a><p><b>Answer options for nme6.3b</b></p><ul><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: mla (&quot;Adverse Non-Medical Event consisted of a missed lab or assessment by a participant (which does not jeopardize the study or increase risks to other participants)&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: mtd (&quot;Adverse Non-Medical Event consisted of a missed treatment or dose by a participant (which does not jeopardize the study or increase risks to other participants&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: otherreason (&quot;Other reason&quot;)</li></ul><a name=\"opt-item.nme6.5\"> </a><p><b>Answer options for nme6.5</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html\">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul></div>"
  ];
  fhir:DomainResource.extension [
     fhir:index 0;
     fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/variable" ];
     fhir:Extension.valueExpression [
       fhir:Expression.description [ fhir:value "response to get the data from" ];
       fhir:Expression.name [ fhir:value "lookupInitiateStudy" ];
       fhir:Expression.language [ fhir:value "application/x-fhir-query" ];
       fhir:Expression.expression [ fhir:value "https://docr-fhir.dev.cloud.duke.edu/hapi-fhir-jpaserver/fhir/QuestionnaireResponse/QRIDInitiateStudy" ]     ]
  ];
  fhir:Questionnaire.url [ fhir:value "https://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevents-questionnaire"];
  fhir:Questionnaire.version [ fhir:value "0.1.0"];
  fhir:Questionnaire.name [ fhir:value "NonMedical_events"];
  fhir:Questionnaire.title [ fhir:value "Adverse Non-Medical Event Questionnaire"];
  fhir:Questionnaire.status [ fhir:value "draft"];
  fhir:Questionnaire.experimental [ fhir:value "false"^^xsd:boolean];
  fhir:Questionnaire.subjectType [
     fhir:value "ResearchStudy";
     fhir:index 0
  ];
  fhir:Questionnaire.date [ fhir:value "2021-08-10T13:15:03+00:00"^^xsd:dateTime];
  fhir:Questionnaire.publisher [ fhir:value "HL7 International - BR&R Work Group"];
  fhir:Questionnaire.contact [
     fhir:index 0;
     fhir:ContactDetail.name [ fhir:value "HL7 International - Biomedical Research and Regulation" ];
     fhir:ContactDetail.telecom [
       fhir:index 0;
       fhir:ContactPoint.system [ fhir:value "url" ];
       fhir:ContactPoint.value [ fhir:value "http://www.hl7.org/Special/committees/rcrim" ]     ]
  ];
  fhir:Questionnaire.jurisdiction [
     fhir:index 0;
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "urn:iso:std:iso:3166" ];
       fhir:Coding.code [ fhir:value "US" ];
       fhir:Coding.display [ fhir:value "United States of America" ]     ];
     fhir:CodeableConcept.text [ fhir:value "United States of America" ]
  ];
  fhir:Questionnaire.item [
     fhir:index 0;
     fhir:Questionnaire.item.linkId [ fhir:value "nme1" ];
     fhir:Questionnaire.item.text [ fhir:value "Research Study" ];
     fhir:Questionnaire.item.type [ fhir:value "group" ];
     fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
     fhir:Questionnaire.item.item [
       fhir:index 0;
       fhir:Questionnaire.item.linkId [ fhir:value "nme1.1" ];
       fhir:Questionnaire.item.text [ fhir:value "Study Title:" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme1.1_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Study Title from the Informed Consent" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 1;
       fhir:Questionnaire.item.linkId [ fhir:value "nme1.3" ];
       fhir:Questionnaire.item.text [ fhir:value "IRB Protocol Number:" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme1.3_help" ];
         fhir:Questionnaire.item.text [ fhir:value "IRB Number from the Informed Consent" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 2;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
         fhir:Extension.valueCodeableConcept [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
             fhir:Coding.code [ fhir:value "drop-down" ];
             fhir:Coding.display [ fhir:value "Drop down" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Drop down" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "nme1.4" ];
       fhir:Questionnaire.item.text [ fhir:value "Status:" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.answerOption [
         fhir:index 0;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "nochange" ];
           fhir:Coding.display [ fhir:value "No change in research activities" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "stopped" ];
           fhir:Coding.display [ fhir:value "All research activities temporarily and voluntarily stopped for all participants" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "partial" ];
           fhir:Coding.display [ fhir:value "Partial voluntary hold on some research activities for all participants (explain below)" ]         ]       ], [
         fhir:index 3;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "hold" ];
           fhir:Coding.display [ fhir:value "Voluntary hold on new participant enrollment only" ]         ]       ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme1.4_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Status of study research activities" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 3;
       fhir:Questionnaire.item.linkId [ fhir:value "nme1.5" ];
       fhir:Questionnaire.item.text [ fhir:value "If partial, please explain:" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme1.4" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "partial" ]         ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme1.5_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Explanation for voluntary hold on new participant enrollment." ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ]
  ], [
     fhir:index 1;
     fhir:Questionnaire.item.linkId [ fhir:value "nme2a" ];
     fhir:Questionnaire.item.text [ fhir:value "Site/Organization" ];
     fhir:Questionnaire.item.type [ fhir:value "group" ];
     fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
     fhir:Questionnaire.item.item [
       fhir:index 0;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
         fhir:Extension.valueCodeableConcept [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
             fhir:Coding.code [ fhir:value "help" ];
             fhir:Coding.display [ fhir:value "Help-Button" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Help-Button" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "nme2a_help" ];
       fhir:Questionnaire.item.text [ fhir:value "Location of Adverse Non-Medical Event" ];
       fhir:Questionnaire.item.type [ fhir:value "display" ]     ], [
       fhir:index 1;
       fhir:Questionnaire.item.linkId [ fhir:value "nme2a.1" ];
       fhir:Questionnaire.item.text [ fhir:value "Organization/site where the Adverse Non-Medical Event occurred" ];
       fhir:Questionnaire.item.type [ fhir:value "group" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Questionnaire.item.linkId [ fhir:value "nme2a.1.1" ];
         fhir:Questionnaire.item.text [ fhir:value "Name of organization/site where the Adverse Non-Medical Event occurred" ];
         fhir:Questionnaire.item.type [ fhir:value "string" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.linkId [ fhir:value "nme2a.1.2" ];
         fhir:Questionnaire.item.text [ fhir:value "City" ];
         fhir:Questionnaire.item.type [ fhir:value "string" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.linkId [ fhir:value "nme2a.1.3" ];
         fhir:Questionnaire.item.text [ fhir:value "State" ];
         fhir:Questionnaire.item.type [ fhir:value "string" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ]       ], [
         fhir:index 3;
         fhir:Questionnaire.item.linkId [ fhir:value "nme2a.1.4" ];
         fhir:Questionnaire.item.text [ fhir:value "Country" ];
         fhir:Questionnaire.item.type [ fhir:value "string" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ]       ]     ], [
       fhir:index 2;
       fhir:Questionnaire.item.linkId [ fhir:value "nme2a.2" ];
       fhir:Questionnaire.item.text [ fhir:value "Organization/site which is recording the Adverse Non-Medical Event" ];
       fhir:Questionnaire.item.type [ fhir:value "group" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Questionnaire.item.linkId [ fhir:value "nme2a.2.1" ];
         fhir:Questionnaire.item.text [ fhir:value "Name of organization/site which is recording the Adverse Non-Medical Event" ];
         fhir:Questionnaire.item.type [ fhir:value "string" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.linkId [ fhir:value "nme2a.2.2" ];
         fhir:Questionnaire.item.text [ fhir:value "City" ];
         fhir:Questionnaire.item.type [ fhir:value "string" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.linkId [ fhir:value "nme2a.2.3" ];
         fhir:Questionnaire.item.text [ fhir:value "State" ];
         fhir:Questionnaire.item.type [ fhir:value "string" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ]       ], [
         fhir:index 3;
         fhir:Questionnaire.item.linkId [ fhir:value "nme2a.2.4" ];
         fhir:Questionnaire.item.text [ fhir:value "Country" ];
         fhir:Questionnaire.item.type [ fhir:value "string" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ]       ]     ]
  ], [
     fhir:index 2;
     fhir:Questionnaire.item.linkId [ fhir:value "nme2b" ];
     fhir:Questionnaire.item.text [ fhir:value "Site Principal Investigator for the site where Adverse Non-Medical Event occurred" ];
     fhir:Questionnaire.item.type [ fhir:value "group" ];
     fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
     fhir:Questionnaire.item.item [
       fhir:index 0;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
         fhir:Extension.valueCodeableConcept [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
             fhir:Coding.code [ fhir:value "help" ];
             fhir:Coding.display [ fhir:value "Help-Button" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Help-Button" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "nme2b_help" ];
       fhir:Questionnaire.item.text [ fhir:value "Site Principal Investigator responsible for the research study at the site where Adverse Non-Medical Event occurred" ];
       fhir:Questionnaire.item.type [ fhir:value "display" ]     ], [
       fhir:index 1;
       fhir:Questionnaire.item.linkId [ fhir:value "nme2b.1" ];
       fhir:Questionnaire.item.text [ fhir:value "First Name" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme2b.1_help" ];
         fhir:Questionnaire.item.text [ fhir:value "First or given name associated with the site PI" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 2;
       fhir:Questionnaire.item.linkId [ fhir:value "nme2b.4" ];
       fhir:Questionnaire.item.text [ fhir:value "Last Name" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.readOnly [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme2b.4_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Surname or family name associated with the  principal investigator" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 3;
       fhir:Questionnaire.item.linkId [ fhir:value "nme2b.5" ];
       fhir:Questionnaire.item.text [ fhir:value "Suffix" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.readOnly [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme2b.5_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the principal investigator's name" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 4;
       fhir:Questionnaire.item.linkId [ fhir:value "nme2b.6" ];
       fhir:Questionnaire.item.text [ fhir:value "Degree(s)" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.readOnly [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme2b.6_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Professional and Academic degrees associated with the principal investigator" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 5;
       fhir:Questionnaire.item.linkId [ fhir:value "nme2b.2" ];
       fhir:Questionnaire.item.text [ fhir:value "Phone:" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme2b.2_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Phone number for site PI" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 6;
       fhir:Questionnaire.item.linkId [ fhir:value "nme2b.3" ];
       fhir:Questionnaire.item.text [ fhir:value "Email:" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme2b.3_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Email address for site PI" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ]
  ], [
     fhir:index 3;
     fhir:Questionnaire.item.linkId [ fhir:value "nme3" ];
     fhir:Questionnaire.item.text [ fhir:value "Report" ];
     fhir:Questionnaire.item.type [ fhir:value "group" ];
     fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
     fhir:Questionnaire.item.item [
       fhir:index 0;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
         fhir:Extension.valueCodeableConcept [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
             fhir:Coding.code [ fhir:value "help" ];
             fhir:Coding.display [ fhir:value "Help-Button" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Help-Button" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "nme3_help" ];
       fhir:Questionnaire.item.text [ fhir:value "Non-medical adverse event report" ];
       fhir:Questionnaire.item.type [ fhir:value "display" ]     ], [
       fhir:index 1;
       fhir:Questionnaire.item.linkId [ fhir:value "nme3.1" ];
       fhir:Questionnaire.item.text [ fhir:value "Report Date:" ];
       fhir:Questionnaire.item.type [ fhir:value "date" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.1_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Date report is created" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 2;
       fhir:Questionnaire.item.linkId [ fhir:value "nme3.2" ];
       fhir:Questionnaire.item.text [ fhir:value "Report Status" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.readOnly [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.answerOption [
         fhir:index 0;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "init" ];
           fhir:Coding.display [ fhir:value "Initial" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "followup" ];
           fhir:Coding.display [ fhir:value "Follow-up" ]         ]       ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.2_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator if report is the Initial report or follow-up report" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 3;
       fhir:Questionnaire.item.linkId [ fhir:value "nme3.3" ];
       fhir:Questionnaire.item.text [ fhir:value "Check at least one of the following criteria:" ];
       fhir:Questionnaire.item.type [ fhir:value "group" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.3_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Reason for uanticipated problem reporting" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 4;
       fhir:Questionnaire.item.linkId [ fhir:value "nme3.4" ];
       fhir:Questionnaire.item.text [ fhir:value "New information resulted in unexpected change in risks of the research." ];
       fhir:Questionnaire.item.type [ fhir:value "boolean" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.4_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator if new information resulted in unexpected change in risks of research" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 5;
       fhir:Questionnaire.item.linkId [ fhir:value "nme3.5" ];
       fhir:Questionnaire.item.text [ fhir:value "New or increased risk" ];
       fhir:Questionnaire.item.type [ fhir:value "group" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.4" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerBoolean [ fhir:value "true"^^xsd:boolean ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.5.1" ];
         fhir:Questionnaire.item.text [ fhir:value "Date:" ];
         fhir:Questionnaire.item.type [ fhir:value "date" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.5.1_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Date new or increased risk first documented" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.5.2" ];
         fhir:Questionnaire.item.text [ fhir:value "Date discovered:" ];
         fhir:Questionnaire.item.type [ fhir:value "date" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.5.2_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Date new or increased risk discovered" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.5.3" ];
         fhir:Questionnaire.item.text [ fhir:value "Description:" ];
         fhir:Questionnaire.item.type [ fhir:value "text" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.5.3_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Description of new or increased risk" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ]     ], [
       fhir:index 6;
       fhir:Questionnaire.item.linkId [ fhir:value "nme3.6" ];
       fhir:Questionnaire.item.text [ fhir:value "Unanticipated Problem Involving Risk to Participants or Others" ];
       fhir:Questionnaire.item.type [ fhir:value "boolean" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.6_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator if problem Involved risk to participants or others" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 7;
       fhir:Questionnaire.item.linkId [ fhir:value "nme3.7" ];
       fhir:Questionnaire.item.text [ fhir:value "Unanticipated Problem" ];
       fhir:Questionnaire.item.type [ fhir:value "group" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.6" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerBoolean [ fhir:value "true"^^xsd:boolean ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.1" ];
         fhir:Questionnaire.item.text [ fhir:value "Event date:" ];
         fhir:Questionnaire.item.type [ fhir:value "date" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.1_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Date event occurred" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.2" ];
         fhir:Questionnaire.item.text [ fhir:value "Date event became aware to study team:" ];
         fhir:Questionnaire.item.type [ fhir:value "date" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.2_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Date site research team first became aware of unanticipated problem" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.3" ];
         fhir:Questionnaire.item.text [ fhir:value "Event Summary:" ];
         fhir:Questionnaire.item.type [ fhir:value "text" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.3_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Summary description of unanticipated problem" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 3;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "drop-down" ];
               fhir:Coding.display [ fhir:value "Drop down" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Drop down" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.4" ];
         fhir:Questionnaire.item.text [ fhir:value "Was this event Unexpected?" ];
         fhir:Questionnaire.item.type [ fhir:value "choice" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.answerOption [
           fhir:index 0;
           fhir:Questionnaire.item.answerOption.valueCoding [
             fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
             fhir:Coding.code [ fhir:value "Y" ];
             fhir:Coding.display [ fhir:value "Yes" ]           ]         ], [
           fhir:index 1;
           fhir:Questionnaire.item.answerOption.valueCoding [
             fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
             fhir:Coding.code [ fhir:value "N" ];
             fhir:Coding.display [ fhir:value "No" ]           ]         ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.4_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Indicator if unanticipated problem was unexpected" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 4;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.5" ];
         fhir:Questionnaire.item.text [ fhir:value "If yes, please explain:" ];
         fhir:Questionnaire.item.type [ fhir:value "text" ];
         fhir:Questionnaire.item.enableWhen [
           fhir:index 0;
           fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.7.4" ];
           fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
           fhir:Questionnaire.item.enableWhen.answerCoding [
             fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
             fhir:Coding.code [ fhir:value "Y" ]           ]         ];
         fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.5_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Explanation for why unanticipated problem was unexpected" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 5;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "drop-down" ];
               fhir:Coding.display [ fhir:value "Drop down" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Drop down" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.6" ];
         fhir:Questionnaire.item.text [ fhir:value "Was this event Related or Possibly Related to participation in the research?" ];
         fhir:Questionnaire.item.type [ fhir:value "choice" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.answerOption [
           fhir:index 0;
           fhir:Questionnaire.item.answerOption.valueCoding [
             fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
             fhir:Coding.code [ fhir:value "Y" ];
             fhir:Coding.display [ fhir:value "Yes" ]           ]         ], [
           fhir:index 1;
           fhir:Questionnaire.item.answerOption.valueCoding [
             fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
             fhir:Coding.code [ fhir:value "N" ];
             fhir:Coding.display [ fhir:value "No" ]           ]         ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.6_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Unanticipated problem associated with participation in the research study" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 6;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.7" ];
         fhir:Questionnaire.item.text [ fhir:value "If yes, please explain:" ];
         fhir:Questionnaire.item.type [ fhir:value "text" ];
         fhir:Questionnaire.item.enableWhen [
           fhir:index 0;
           fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.7.6" ];
           fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
           fhir:Questionnaire.item.enableWhen.answerCoding [
             fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
             fhir:Coding.code [ fhir:value "Y" ]           ]         ];
         fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.7_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Explanation for why unanticipated problem is associated with participation in this research" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 7;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "drop-down" ];
               fhir:Coding.display [ fhir:value "Drop down" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Drop down" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.8" ];
         fhir:Questionnaire.item.text [ fhir:value "Does this event suggest that the research places participant(s) or others at a greater Risk of harm than was previously known?" ];
         fhir:Questionnaire.item.type [ fhir:value "choice" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.answerOption [
           fhir:index 0;
           fhir:Questionnaire.item.answerOption.valueCoding [
             fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
             fhir:Coding.code [ fhir:value "Y" ];
             fhir:Coding.display [ fhir:value "Yes" ]           ]         ], [
           fhir:index 1;
           fhir:Questionnaire.item.answerOption.valueCoding [
             fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
             fhir:Coding.code [ fhir:value "N" ];
             fhir:Coding.display [ fhir:value "No" ]           ]         ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.8_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Indicator if unanticipated problem increased risk of harm to  participants" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 8;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.9" ];
         fhir:Questionnaire.item.text [ fhir:value "If yes, please explain:" ];
         fhir:Questionnaire.item.type [ fhir:value "text" ];
         fhir:Questionnaire.item.enableWhen [
           fhir:index 0;
           fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.7.8" ];
           fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
           fhir:Questionnaire.item.enableWhen.answerCoding [
             fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
             fhir:Coding.code [ fhir:value "Y" ]           ]         ];
         fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.7.9_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Explanation for why unanticipated problem is associated with increased risk of harm for research participants" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ]     ], [
       fhir:index 8;
       fhir:Questionnaire.item.linkId [ fhir:value "nme3.8" ];
       fhir:Questionnaire.item.text [ fhir:value "Protocol Deviation (accidental or unintentional)" ];
       fhir:Questionnaire.item.type [ fhir:value "boolean" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.8_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator protocol  deviation was accidental or unintentional" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 9;
       fhir:Questionnaire.item.linkId [ fhir:value "nme3.9" ];
       fhir:Questionnaire.item.text [ fhir:value "Protocol Deviation (Non-Compliance)" ];
       fhir:Questionnaire.item.type [ fhir:value "group" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.8" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerBoolean [ fhir:value "true"^^xsd:boolean ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.1" ];
         fhir:Questionnaire.item.text [ fhir:value "Date:" ];
         fhir:Questionnaire.item.type [ fhir:value "date" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.1_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Date non-compliance first identified" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.2" ];
         fhir:Questionnaire.item.text [ fhir:value "Date discovered:" ];
         fhir:Questionnaire.item.type [ fhir:value "date" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.2_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Date site research team first discovered non-compliance protocol deviation" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.3" ];
         fhir:Questionnaire.item.text [ fhir:value "Description:" ];
         fhir:Questionnaire.item.type [ fhir:value "text" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.3_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Description of non-compliance protocol deviation" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 3;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.4" ];
         fhir:Questionnaire.item.text [ fhir:value "Does the deviation involve any of the following? (Check all that apply)" ];
         fhir:Questionnaire.item.type [ fhir:value "group" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.4_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Reason for protocol deviation" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ], [
           fhir:index 1;
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.4.1" ];
           fhir:Questionnaire.item.text [ fhir:value "Failure to obtain informed consent when IRB deemed required" ];
           fhir:Questionnaire.item.type [ fhir:value "boolean" ];
           fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
           fhir:Questionnaire.item.item [
             fhir:index 0;
             fhir:Element.extension [
               fhir:index 0;
               fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
               fhir:Extension.valueCodeableConcept [
                 fhir:CodeableConcept.coding [
                   fhir:index 0;
                   fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                   fhir:Coding.code [ fhir:value "help" ];
                   fhir:Coding.display [ fhir:value "Help-Button" ]                 ];
                 fhir:CodeableConcept.text [ fhir:value "Help-Button" ]               ]             ];
             fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.4.1_help" ];
             fhir:Questionnaire.item.text [ fhir:value "Informed consent not obtained when required by IRB" ];
             fhir:Questionnaire.item.type [ fhir:value "display" ]           ]         ], [
           fhir:index 2;
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.4.2" ];
           fhir:Questionnaire.item.text [ fhir:value "Modifying the protocol without IRB approval, except to avoid hazard to participants" ];
           fhir:Questionnaire.item.type [ fhir:value "boolean" ];
           fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
           fhir:Questionnaire.item.item [
             fhir:index 0;
             fhir:Element.extension [
               fhir:index 0;
               fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
               fhir:Extension.valueCodeableConcept [
                 fhir:CodeableConcept.coding [
                   fhir:index 0;
                   fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                   fhir:Coding.code [ fhir:value "help" ];
                   fhir:Coding.display [ fhir:value "Help-Button" ]                 ];
                 fhir:CodeableConcept.text [ fhir:value "Help-Button" ]               ]             ];
             fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.4.2_help" ];
             fhir:Questionnaire.item.text [ fhir:value "Protocol modified without IRB approval" ];
             fhir:Questionnaire.item.type [ fhir:value "display" ]           ]         ], [
           fhir:index 3;
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.4.3" ];
           fhir:Questionnaire.item.text [ fhir:value "Conducting research prior to IRB approval, during an IRB suspension or after IRB approval ends" ];
           fhir:Questionnaire.item.type [ fhir:value "boolean" ];
           fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
           fhir:Questionnaire.item.item [
             fhir:index 0;
             fhir:Element.extension [
               fhir:index 0;
               fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
               fhir:Extension.valueCodeableConcept [
                 fhir:CodeableConcept.coding [
                   fhir:index 0;
                   fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                   fhir:Coding.code [ fhir:value "help" ];
                   fhir:Coding.display [ fhir:value "Help-Button" ]                 ];
                 fhir:CodeableConcept.text [ fhir:value "Help-Button" ]               ]             ];
             fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.4.3_help" ];
             fhir:Questionnaire.item.text [ fhir:value "Conducting research without IRB approval" ];
             fhir:Questionnaire.item.type [ fhir:value "display" ]           ]         ], [
           fhir:index 4;
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.4.4" ];
           fhir:Questionnaire.item.text [ fhir:value "Please explain any Checked items:" ];
           fhir:Questionnaire.item.type [ fhir:value "text" ];
           fhir:Questionnaire.item.enableWhen [
             fhir:index 0;
             fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.9.4.1" ];
             fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
             fhir:Questionnaire.item.enableWhen.answerBoolean [ fhir:value "true"^^xsd:boolean ]           ], [
             fhir:index 1;
             fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.9.4.2" ];
             fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
             fhir:Questionnaire.item.enableWhen.answerBoolean [ fhir:value "true"^^xsd:boolean ]           ], [
             fhir:index 2;
             fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.9.4.3" ];
             fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
             fhir:Questionnaire.item.enableWhen.answerBoolean [ fhir:value "true"^^xsd:boolean ]           ];
           fhir:Questionnaire.item.enableBehavior [ fhir:value "any" ];
           fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
           fhir:Questionnaire.item.item [
             fhir:index 0;
             fhir:Element.extension [
               fhir:index 0;
               fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
               fhir:Extension.valueCodeableConcept [
                 fhir:CodeableConcept.coding [
                   fhir:index 0;
                   fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                   fhir:Coding.code [ fhir:value "help" ];
                   fhir:Coding.display [ fhir:value "Help-Button" ]                 ];
                 fhir:CodeableConcept.text [ fhir:value "Help-Button" ]               ]             ];
             fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.9.4_help" ];
             fhir:Questionnaire.item.text [ fhir:value "Explanation for why protocol deviation category checked" ];
             fhir:Questionnaire.item.type [ fhir:value "display" ]           ]         ]       ], [
         fhir:index 4;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.5" ];
         fhir:Questionnaire.item.text [ fhir:value "Was the deviation a substantive change from the protocol adversely affecting any of the following? (Check all that apply)" ];
         fhir:Questionnaire.item.type [ fhir:value "group" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.5.1" ];
           fhir:Questionnaire.item.text [ fhir:value "The rights, welfare, or safety of the participants" ];
           fhir:Questionnaire.item.type [ fhir:value "boolean" ];
           fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]         ], [
           fhir:index 1;
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.5.2" ];
           fhir:Questionnaire.item.text [ fhir:value "The integrity of the research area" ];
           fhir:Questionnaire.item.type [ fhir:value "boolean" ];
           fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]         ], [
           fhir:index 2;
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.5.3" ];
           fhir:Questionnaire.item.text [ fhir:value "The participants' willingness to continue participation" ];
           fhir:Questionnaire.item.type [ fhir:value "boolean" ];
           fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]         ], [
           fhir:index 3;
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.9.5.4" ];
           fhir:Questionnaire.item.text [ fhir:value "Please explain any Checked items:" ];
           fhir:Questionnaire.item.type [ fhir:value "text" ];
           fhir:Questionnaire.item.enableWhen [
             fhir:index 0;
             fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.9.5.1" ];
             fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
             fhir:Questionnaire.item.enableWhen.answerBoolean [ fhir:value "true"^^xsd:boolean ]           ], [
             fhir:index 1;
             fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.9.5.2" ];
             fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
             fhir:Questionnaire.item.enableWhen.answerBoolean [ fhir:value "true"^^xsd:boolean ]           ], [
             fhir:index 2;
             fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.9.5.3" ];
             fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
             fhir:Questionnaire.item.enableWhen.answerBoolean [ fhir:value "true"^^xsd:boolean ]           ];
           fhir:Questionnaire.item.enableBehavior [ fhir:value "any" ];
           fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]         ]       ]     ], [
       fhir:index 10;
       fhir:Questionnaire.item.linkId [ fhir:value "nme3.10" ];
       fhir:Questionnaire.item.text [ fhir:value "A breach of Confidentiality" ];
       fhir:Questionnaire.item.type [ fhir:value "boolean" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.10_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator of breach of confidentiality" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 11;
       fhir:Questionnaire.item.linkId [ fhir:value "nme3.11" ];
       fhir:Questionnaire.item.text [ fhir:value "Breach of Confidentiality" ];
       fhir:Questionnaire.item.type [ fhir:value "group" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.10" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerBoolean [ fhir:value "true"^^xsd:boolean ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.11.1" ];
         fhir:Questionnaire.item.text [ fhir:value "Date breach occurred" ];
         fhir:Questionnaire.item.type [ fhir:value "date" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.11.1_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Date breach of confidentiality first documented" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.11.2" ];
         fhir:Questionnaire.item.text [ fhir:value "Date discovered:" ];
         fhir:Questionnaire.item.type [ fhir:value "date" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.11.2_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Date site study team discovered breach of confidentiality" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.11.3" ];
         fhir:Questionnaire.item.text [ fhir:value "Description:" ];
         fhir:Questionnaire.item.type [ fhir:value "text" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.11.3_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Breach of confidentiality description" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 3;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.11_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator of breach of confidentiality" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 12;
       fhir:Questionnaire.item.linkId [ fhir:value "nme3.12" ];
       fhir:Questionnaire.item.text [ fhir:value "Incarceration of a participant in a protocol not approved to enroll prisoners" ];
       fhir:Questionnaire.item.type [ fhir:value "boolean" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.12_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator of a study participant incarcerated when the protocol is not approved for prisoner enrollment" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 13;
       fhir:Questionnaire.item.linkId [ fhir:value "nme3.13" ];
       fhir:Questionnaire.item.text [ fhir:value "Incarceration" ];
       fhir:Questionnaire.item.type [ fhir:value "group" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.12" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerBoolean [ fhir:value "true"^^xsd:boolean ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.13.1" ];
         fhir:Questionnaire.item.text [ fhir:value "Date:" ];
         fhir:Questionnaire.item.type [ fhir:value "date" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.13.1_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Date site first documented participant incarceration." ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.13.2" ];
         fhir:Questionnaire.item.text [ fhir:value "Date incarceration was discovered:" ];
         fhir:Questionnaire.item.type [ fhir:value "date" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.13.2_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Data site study team discovered patient incarceration" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.13.3" ];
         fhir:Questionnaire.item.text [ fhir:value "Description:" ];
         fhir:Questionnaire.item.type [ fhir:value "text" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.13.3_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Description of patient incarceration" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ]     ], [
       fhir:index 14;
       fhir:Questionnaire.item.linkId [ fhir:value "nme3.14" ];
       fhir:Questionnaire.item.text [ fhir:value "Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team." ];
       fhir:Questionnaire.item.type [ fhir:value "boolean" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.readOnly [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.14_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator if participant complaint of unexpected risks was not resolved by study team. Complaint information is related to study site." ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 15;
       fhir:Questionnaire.item.linkId [ fhir:value "nme3.15" ];
       fhir:Questionnaire.item.text [ fhir:value "Participant Complaint" ];
       fhir:Questionnaire.item.type [ fhir:value "group" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.14" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerBoolean [ fhir:value "true"^^xsd:boolean ]       ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.15.1" ];
         fhir:Questionnaire.item.text [ fhir:value "Complaint Date:" ];
         fhir:Questionnaire.item.type [ fhir:value "date" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.readOnly [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.15.1_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Date site first documented participant unexpected risk complaint" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.15.2" ];
         fhir:Questionnaire.item.text [ fhir:value "Date received:" ];
         fhir:Questionnaire.item.type [ fhir:value "date" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.15.2_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Date site personnel first received participant unexpected risk complaint" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.15.3" ];
         fhir:Questionnaire.item.text [ fhir:value "Description:" ];
         fhir:Questionnaire.item.type [ fhir:value "text" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.15.3_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Description of participant unexpected risk complaint" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ]     ], [
       fhir:index 16;
       fhir:Questionnaire.item.linkId [ fhir:value "nme3.16" ];
       fhir:Questionnaire.item.text [ fhir:value "Other Type of Adverse Non-Medical Event" ];
       fhir:Questionnaire.item.type [ fhir:value "boolean" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.16_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator for other type of Adverse Non-Medical Event" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 17;
       fhir:Questionnaire.item.linkId [ fhir:value "nme3.17" ];
       fhir:Questionnaire.item.text [ fhir:value "Other Type" ];
       fhir:Questionnaire.item.type [ fhir:value "group" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.16" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerBoolean [ fhir:value "true"^^xsd:boolean ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.17.1" ];
         fhir:Questionnaire.item.text [ fhir:value "Event date:" ];
         fhir:Questionnaire.item.type [ fhir:value "date" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.17.1_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Date event occurred" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.17.2" ];
         fhir:Questionnaire.item.text [ fhir:value "Date study team became aware of event:" ];
         fhir:Questionnaire.item.type [ fhir:value "date" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.17.2_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Date site research team first became aware of the event" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.17.3" ];
         fhir:Questionnaire.item.text [ fhir:value "Event Summary:" ];
         fhir:Questionnaire.item.type [ fhir:value "text" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.17.3_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Summary description of the event" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 3;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "drop-down" ];
               fhir:Coding.display [ fhir:value "Drop down" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Drop down" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.17.4" ];
         fhir:Questionnaire.item.text [ fhir:value "Was this Adverse Non-Medical Event Unexpected?" ];
         fhir:Questionnaire.item.type [ fhir:value "choice" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.answerOption [
           fhir:index 0;
           fhir:Questionnaire.item.answerOption.valueCoding [
             fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
             fhir:Coding.code [ fhir:value "Y" ];
             fhir:Coding.display [ fhir:value "Yes" ]           ]         ], [
           fhir:index 1;
           fhir:Questionnaire.item.answerOption.valueCoding [
             fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
             fhir:Coding.code [ fhir:value "N" ];
             fhir:Coding.display [ fhir:value "No" ]           ]         ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.17.4_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Indicator if event was unexpected" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 4;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.17.5" ];
         fhir:Questionnaire.item.text [ fhir:value "If yes, please explain:" ];
         fhir:Questionnaire.item.type [ fhir:value "text" ];
         fhir:Questionnaire.item.enableWhen [
           fhir:index 0;
           fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.17.4" ];
           fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
           fhir:Questionnaire.item.enableWhen.answerCoding [
             fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
             fhir:Coding.code [ fhir:value "Y" ]           ]         ];
         fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.17.5_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Explanation for why event was unexpected" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 5;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "drop-down" ];
               fhir:Coding.display [ fhir:value "Drop down" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Drop down" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.17.6" ];
         fhir:Questionnaire.item.text [ fhir:value "Was this event Related or Possibly Related to participation in the research?" ];
         fhir:Questionnaire.item.type [ fhir:value "choice" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.answerOption [
           fhir:index 0;
           fhir:Questionnaire.item.answerOption.valueCoding [
             fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
             fhir:Coding.code [ fhir:value "Y" ];
             fhir:Coding.display [ fhir:value "Yes" ]           ]         ], [
           fhir:index 1;
           fhir:Questionnaire.item.answerOption.valueCoding [
             fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
             fhir:Coding.code [ fhir:value "N" ];
             fhir:Coding.display [ fhir:value "No" ]           ]         ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.17.6_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Adverse Non-Medical Event association with participation in the research study" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 6;
         fhir:Questionnaire.item.linkId [ fhir:value "nme3.17.7" ];
         fhir:Questionnaire.item.text [ fhir:value "If yes, please explain:" ];
         fhir:Questionnaire.item.type [ fhir:value "text" ];
         fhir:Questionnaire.item.enableWhen [
           fhir:index 0;
           fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme3.17.6" ];
           fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
           fhir:Questionnaire.item.enableWhen.answerCoding [
             fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
             fhir:Coding.code [ fhir:value "Y" ]           ]         ];
         fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
         fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
         fhir:Questionnaire.item.item [
           fhir:index 0;
           fhir:Element.extension [
             fhir:index 0;
             fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
             fhir:Extension.valueCodeableConcept [
               fhir:CodeableConcept.coding [
                 fhir:index 0;
                 fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
                 fhir:Coding.code [ fhir:value "help" ];
                 fhir:Coding.display [ fhir:value "Help-Button" ]               ];
               fhir:CodeableConcept.text [ fhir:value "Help-Button" ]             ]           ];
           fhir:Questionnaire.item.linkId [ fhir:value "nme3.17.7_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Explanation for why the event is associated with participation in this research" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ]     ]
  ], [
     fhir:index 4;
     fhir:Questionnaire.item.linkId [ fhir:value "nme4" ];
     fhir:Questionnaire.item.text [ fhir:value "Reporting" ];
     fhir:Questionnaire.item.type [ fhir:value "group" ];
     fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
     fhir:Questionnaire.item.item [
       fhir:index 0;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
         fhir:Extension.valueCodeableConcept [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
             fhir:Coding.code [ fhir:value "help" ];
             fhir:Coding.display [ fhir:value "Help-Button" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Help-Button" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "nme4_help" ];
       fhir:Questionnaire.item.text [ fhir:value "Reporting information to Sponsor and both relying and reviewing IRBs" ];
       fhir:Questionnaire.item.type [ fhir:value "display" ]     ], [
       fhir:index 1;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
         fhir:Extension.valueCodeableConcept [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
             fhir:Coding.code [ fhir:value "drop-down" ];
             fhir:Coding.display [ fhir:value "Drop down" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Drop down" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "nme4.1" ];
       fhir:Questionnaire.item.text [ fhir:value "Was the Sponsor notified?" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.answerOption [
         fhir:index 0;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "Y" ];
           fhir:Coding.display [ fhir:value "Yes" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "N" ];
           fhir:Coding.display [ fhir:value "No" ]         ]       ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme4.1_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator if Sponsor was notified of non-medical adverse event" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 2;
       fhir:Questionnaire.item.linkId [ fhir:value "nme4.2" ];
       fhir:Questionnaire.item.text [ fhir:value "Notification date:" ];
       fhir:Questionnaire.item.type [ fhir:value "date" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme4.1" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "Y" ]         ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme4.2_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Date sponsor notified of non-medical adverse event" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 3;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
         fhir:Extension.valueCodeableConcept [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
             fhir:Coding.code [ fhir:value "drop-down" ];
             fhir:Coding.display [ fhir:value "Drop down" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Drop down" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "nme4.3" ];
       fhir:Questionnaire.item.text [ fhir:value "Was the IRB notified?" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.answerOption [
         fhir:index 0;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "Y" ];
           fhir:Coding.display [ fhir:value "Yes" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "N" ];
           fhir:Coding.display [ fhir:value "No" ]         ]       ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme4.3_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator if study site IRB notified of non-medical adverse event" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 4;
       fhir:Questionnaire.item.linkId [ fhir:value "nme4.4" ];
       fhir:Questionnaire.item.text [ fhir:value "Notification date:" ];
       fhir:Questionnaire.item.type [ fhir:value "date" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme4.3" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "Y" ]         ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme4.4_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Date study site IRB notified of non-medical adverse event" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 5;
       fhir:Questionnaire.item.linkId [ fhir:value "nme4.5" ];
       fhir:Questionnaire.item.text [ fhir:value "Were any Other Parties notified?" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.readOnly [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.answerOption [
         fhir:index 0;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "Y" ];
           fhir:Coding.display [ fhir:value "Yes" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "N" ];
           fhir:Coding.display [ fhir:value "No" ]         ]       ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme4.5_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Other parties notified of non-medical adverse event (such as coordinating center, other study sites, FDA)" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 6;
       fhir:Questionnaire.item.linkId [ fhir:value "nme4.6" ];
       fhir:Questionnaire.item.text [ fhir:value "Please list other notified parties" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme4.5" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "Y" ]         ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.repeats [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.readOnly [ fhir:value "false"^^xsd:boolean ]     ]
  ], [
     fhir:index 5;
     fhir:Questionnaire.item.linkId [ fhir:value "nme5" ];
     fhir:Questionnaire.item.text [ fhir:value "Corrective and Preventative Action Plan" ];
     fhir:Questionnaire.item.type [ fhir:value "group" ];
     fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
     fhir:Questionnaire.item.item [
       fhir:index 0;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
         fhir:Extension.valueCodeableConcept [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
             fhir:Coding.code [ fhir:value "help" ];
             fhir:Coding.display [ fhir:value "Help-Button" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Help-Button" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "nme5_help" ];
       fhir:Questionnaire.item.text [ fhir:value "Description of corrective and preventative action plan" ];
       fhir:Questionnaire.item.type [ fhir:value "display" ]     ], [
       fhir:index 1;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
         fhir:Extension.valueCodeableConcept [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
             fhir:Coding.code [ fhir:value "drop-down" ];
             fhir:Coding.display [ fhir:value "Drop down" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Drop down" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "nme5.1" ];
       fhir:Questionnaire.item.text [ fhir:value "Was a Root Cause analysis performed?" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.answerOption [
         fhir:index 0;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "completed" ];
           fhir:Coding.display [ fhir:value "Done, performed or completed" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "pending" ];
           fhir:Coding.display [ fhir:value "Pending - Currently under development" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "notundertaken" ];
           fhir:Coding.display [ fhir:value "Not done or undertaken" ]         ]       ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme5.1_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicataor if analysis of underlying causes or problems that led to the non-medical adverse event was performed" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 2;
       fhir:Questionnaire.item.linkId [ fhir:value "nme5.2a" ];
       fhir:Questionnaire.item.text [ fhir:value "If yes, provide determination:" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme5.1" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "completed" ]         ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme5.2a_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Description of what the root cause analysis determined the adverse event was caused by" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 3;
       fhir:Questionnaire.item.linkId [ fhir:value "nme5.2b" ];
       fhir:Questionnaire.item.text [ fhir:value "If pending, describe status and interim findings, if any:" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme5.1" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "pending" ]         ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme5.2b_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Describe status and any interim findings of the root cause analysis" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 4;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
         fhir:Extension.valueCodeableConcept [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
             fhir:Coding.code [ fhir:value "drop-down" ];
             fhir:Coding.display [ fhir:value "Drop down" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Drop down" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "nme5.3" ];
       fhir:Questionnaire.item.text [ fhir:value "Was Corrective Action implemented?" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.answerOption [
         fhir:index 0;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "completed" ];
           fhir:Coding.display [ fhir:value "Done, performed or completed" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "pending" ];
           fhir:Coding.display [ fhir:value "Pending - Currently under development" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "notundertaken" ];
           fhir:Coding.display [ fhir:value "Not done or undertaken" ]         ]       ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme5.3_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator if corrective action is implemented for non-medical adverse event" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 5;
       fhir:Questionnaire.item.linkId [ fhir:value "nme5.4" ];
       fhir:Questionnaire.item.text [ fhir:value "If Corrective Action was implemented or is pending, provide a summary:" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme5.3" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "completed" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme5.3" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "pending" ]         ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "any" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme5.4_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Summary of corrective action implemented for non-medical adverse event. If still pending, provide a status of the corrective action plan" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 6;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
         fhir:Extension.valueCodeableConcept [
           fhir:CodeableConcept.coding [
             fhir:index 0;
             fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
             fhir:Coding.code [ fhir:value "drop-down" ];
             fhir:Coding.display [ fhir:value "Drop down" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Drop down" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "nme5.5" ];
       fhir:Questionnaire.item.text [ fhir:value "Was Preventitive Action implemented?" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.answerOption [
         fhir:index 0;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "completed" ];
           fhir:Coding.display [ fhir:value "Done, performed or completed" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "notundertaken" ];
           fhir:Coding.display [ fhir:value "Not done or undertaken" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "pending" ];
           fhir:Coding.display [ fhir:value "Pending - Currently under development" ]         ]       ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme5.5_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator if preventative action for non-medical adverse event is implemented" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 7;
       fhir:Questionnaire.item.linkId [ fhir:value "nme5.6" ];
       fhir:Questionnaire.item.text [ fhir:value "If Preventitive Action was implemented or is pending, provide a summary:" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme5.5" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "completed" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme5.5" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "pending" ]         ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "any" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
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               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme5.6_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Summary of preventative action implemented for non-medical adverse event. If still pending, provide status." ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ]
  ], [
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     fhir:Questionnaire.item.linkId [ fhir:value "nme6" ];
     fhir:Questionnaire.item.text [ fhir:value "Study Protocol and Informed Consent" ];
     fhir:Questionnaire.item.type [ fhir:value "group" ];
     fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
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         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
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             fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
             fhir:Coding.code [ fhir:value "help" ];
             fhir:Coding.display [ fhir:value "Help-Button" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Help-Button" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "nme6_help" ];
       fhir:Questionnaire.item.text [ fhir:value "Description of protocol and informed consent changes" ];
       fhir:Questionnaire.item.type [ fhir:value "display" ]     ], [
       fhir:index 1;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
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             fhir:Coding.code [ fhir:value "drop-down" ];
             fhir:Coding.display [ fhir:value "Drop down" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Drop down" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "nme6.1a" ];
       fhir:Questionnaire.item.text [ fhir:value "Are changes required to the Study Protocol as a result of this report?" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.answerOption [
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         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "Y" ];
           fhir:Coding.display [ fhir:value "Yes" ]         ]       ], [
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         fhir:Questionnaire.item.answerOption.valueCoding [
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           fhir:Coding.code [ fhir:value "N" ];
           fhir:Coding.display [ fhir:value "No" ]         ]       ];
       fhir:Questionnaire.item.item [
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           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
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               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme6.1a_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator if changes are required in study protocol resulting from the non-medical adverse event report" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
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         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
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             fhir:Coding.display [ fhir:value "Check-box" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Check-box" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "nme6.1b" ];
       fhir:Questionnaire.item.text [ fhir:value "Reason(s) why changes are not required in the Study Protocol:" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.enableWhen [
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         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme6.1a" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
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           fhir:Coding.code [ fhir:value "N" ]         ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.answerOption [
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         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "mla" ];
           fhir:Coding.display [ fhir:value "Adverse Non-Medical Event consisted of a missed lab or assessment by a participant (which does not jeopardize the study or increase risks to other participants)" ]         ]       ], [
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         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "mtd" ];
           fhir:Coding.display [ fhir:value "Adverse Non-Medical Event consisted of a missed treatment or dose by a participant (which does not jeopardize the study or increase risks to other participants" ]         ]       ], [
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         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "otherreason" ];
           fhir:Coding.display [ fhir:value "Other reason" ]         ]       ]     ], [
       fhir:index 3;
       fhir:Questionnaire.item.linkId [ fhir:value "nme6.2" ];
       fhir:Questionnaire.item.text [ fhir:value "Justify your decision to not change the study protocol:" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
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         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme6.1a" ];
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           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "N" ]         ]       ], [
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         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme6.1b" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "otherreason" ]         ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
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           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
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               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme6.2_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Justification for decision not to change study protocol based upon non-medical adverse event report" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 4;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
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             fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
             fhir:Coding.code [ fhir:value "drop-down" ];
             fhir:Coding.display [ fhir:value "Drop down" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Drop down" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "nme6.3a" ];
       fhir:Questionnaire.item.text [ fhir:value "Are changes required to the Informed Consent as a result of this report?" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
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           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
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           fhir:Coding.display [ fhir:value "Yes" ]         ]       ], [
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           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
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           fhir:Coding.display [ fhir:value "No" ]         ]       ];
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           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
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               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme6.3a_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator if changes are required to the informed consent as a result of the non-medical adverse event report" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
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         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
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             fhir:Coding.display [ fhir:value "Check-box" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Check-box" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "nme6.3b" ];
       fhir:Questionnaire.item.text [ fhir:value "Reason(s) why changes are not required in the Informed Consent:" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.enableWhen [
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         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme6.3a" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
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           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "N" ]         ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
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         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "mla" ];
           fhir:Coding.display [ fhir:value "Adverse Non-Medical Event consisted of a missed lab or assessment by a participant (which does not jeopardize the study or increase risks to other participants)" ]         ]       ], [
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         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "mtd" ];
           fhir:Coding.display [ fhir:value "Adverse Non-Medical Event consisted of a missed treatment or dose by a participant (which does not jeopardize the study or increase risks to other participants" ]         ]       ], [
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         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "otherreason" ];
           fhir:Coding.display [ fhir:value "Other reason" ]         ]       ]     ], [
       fhir:index 6;
       fhir:Questionnaire.item.linkId [ fhir:value "nme6.4" ];
       fhir:Questionnaire.item.text [ fhir:value "Justify your decision to not change the Informed Consent:" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
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         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme6.3a" ];
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           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "N" ]         ]       ], [
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         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme6.3b" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
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           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "otherreason" ]         ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
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         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
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             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme6.4_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Justification for decision not to change informed consent based upon non-medical adverse event report" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 7;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
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             fhir:index 0;
             fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
             fhir:Coding.code [ fhir:value "drop-down" ];
             fhir:Coding.display [ fhir:value "Drop down" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Drop down" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "nme6.5" ];
       fhir:Questionnaire.item.text [ fhir:value "Are notifications or re-consenting of participants required as a result of this change?" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme6.1a" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
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           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "Y" ]         ]       ], [
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         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme6.3a" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
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           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "Y" ]         ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "any" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.answerOption [
         fhir:index 0;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "Y" ];
           fhir:Coding.display [ fhir:value "Yes" ]         ]       ], [
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         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "N" ];
           fhir:Coding.display [ fhir:value "No" ]         ]       ];
       fhir:Questionnaire.item.item [
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         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
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               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme6.5_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator if notification or reconsenting of participants is required due to changes in Study Protocol or Informed Consent" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 8;
       fhir:Questionnaire.item.linkId [ fhir:value "nme6.6" ];
       fhir:Questionnaire.item.text [ fhir:value "If yes, detail how the notification and/or re-consent will occur:" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme6.5" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "Y" ]         ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
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               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme6.6_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Description of how notification or re-consent will occur" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 9;
       fhir:Questionnaire.item.linkId [ fhir:value "nme6.7" ];
       fhir:Questionnaire.item.text [ fhir:value "If no, justify your decision to not notify (re-consent) participants:" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "nme6.5" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "N" ]         ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "all" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.item [
         fhir:index 0;
         fhir:Element.extension [
           fhir:index 0;
           fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl" ];
           fhir:Extension.valueCodeableConcept [
             fhir:CodeableConcept.coding [
               fhir:index 0;
               fhir:Coding.system [ fhir:value "http://hl7.org/fhir/questionnaire-item-control" ];
               fhir:Coding.code [ fhir:value "help" ];
               fhir:Coding.display [ fhir:value "Help-Button" ]             ];
             fhir:CodeableConcept.text [ fhir:value "Help-Button" ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "nme6.7_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Rationale for not notifying (re-consenting) study participants" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ]
  ], [
     fhir:index 7;
     fhir:Element.extension [
       fhir:index 0;
       fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden" ];
       fhir:Extension.valueBoolean [ fhir:value "true"^^xsd:boolean ]     ];
     fhir:Questionnaire.item.linkId [ fhir:value "ADMIN00" ];
     fhir:Questionnaire.item.text [ fhir:value "Administrative Use Only" ];
     fhir:Questionnaire.item.type [ fhir:value "group" ];
     fhir:Questionnaire.item.item [
       fhir:index 0;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden" ];
         fhir:Extension.valueBoolean [ fhir:value "true"^^xsd:boolean ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "ADMIN01" ];
       fhir:Questionnaire.item.text [ fhir:value "Link ID prefix" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.initial [
         fhir:index 0;
         fhir:Questionnaire.item.initial.valueString [ fhir:value "nme" ]       ]     ], [
       fhir:index 1;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden" ];
         fhir:Extension.valueBoolean [ fhir:value "true"^^xsd:boolean ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "ADMIN02" ];
       fhir:Questionnaire.item.text [ fhir:value "Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.initial [
         fhir:index 0;
         fhir:Questionnaire.item.initial.valueString [ fhir:value "temporarily unavailable" ]       ]     ], [
       fhir:index 2;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden" ];
         fhir:Extension.valueBoolean [ fhir:value "true"^^xsd:boolean ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "ADMIN03" ];
       fhir:Questionnaire.item.text [ fhir:value "ID of the Research Study FHIR Resource associated with the study Questionnaire Responses" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.initial [
         fhir:index 0;
         fhir:Questionnaire.item.initial.valueString [ fhir:value "temporarily unavailable" ]       ]     ], [
       fhir:index 3;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden" ];
         fhir:Extension.valueBoolean [ fhir:value "true"^^xsd:boolean ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "ADMIN04" ];
       fhir:Questionnaire.item.text [ fhir:value "Questionnaire Response ID of the local considerations Questionnaire Response, if any" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]     ]
  ].

# - ontology header ------------------------------------------------------------

 a owl:Ontology;
  owl:imports fhir:fhir.ttl.