HL7.FHIR.US.SIRB\Adverse 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 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-adverse-event-questionnaire"];
  fhir:Resource.meta [
     fhir:Meta.versionId [ fhir:value "30" ];
     fhir:Meta.lastUpdated [ fhir:value "2021-07-25T19:43:52.262+00:00"^^xsd:dateTime ];
     fhir:Meta.source [ fhir:value "#eJyAreQbrlvM9daT" ]
  ];
  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\"/> AE_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\"></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\"/> mae1</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\"/> mae1.1</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\"/> mae1.1_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\"/> mae1.2</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\"/> mae1.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Number assigned to the protocol by IRB</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\"/> mae1.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Study 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-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.mae1.3\">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\"/> mae1.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)</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\"/> mae1.4</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 protocol require an FDA exemption?</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.mae1.4\">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_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\"/> mae1.4_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 for use of FDA regulated product</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\"/> mae1.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is an IND or IDE being used in this 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-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.mae1.5\">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\"/> mae1.5_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?</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_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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae1.6</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">IND/IDE 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\">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_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\"/> mae2</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</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\"/> mae2.1</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\"/> mae2.1_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 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\"/> mae2.2</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\"/> mae2.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Surname or family name associated with the site 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\"/> mae2.5</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\"/> mae2.5_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 site 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\"/> mae2.6</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\"/> mae2.6_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 site 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_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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae2.3</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_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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae2.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Email</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\"/> mae3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Primary Contact</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\"/> mae3_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Personnel completing the adverse event documentation at the relying site</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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae3.1</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_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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae3.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Last 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-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_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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae3.3</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_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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae3.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Email</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\"/> mae4</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\"/> mae4_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 where adverse event is recorded</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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae4.1</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 where the 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-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_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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae4.2</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 which is recording the Adverse 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-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\"/> mae5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Participant Information</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_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: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae5.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Patient ID</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-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> mae5.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Participant identifier from study case report form</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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae5.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Age</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_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\"/> mae5.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Birth Sex</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.mae5.3\">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_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-quantity.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Quantity\" class=\"hierarchy\"/> mae5.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Weight</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-quantity\">quantity</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-quantity.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Quantity\" class=\"hierarchy\"/> mae5.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Height</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-quantity\">quantity</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\"/> mae5.6</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Ethnicity</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.mae5.6\">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_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\"/> mae5.7</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Race</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</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\"><a href=\"http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-observationLinkPeriod\" title=\"Orientation: vertical\"><img src=\"icon-qi-vertical.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\">Options: <a href=\"#opt-item.mae5.7\">5 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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae5.8</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Which Arm/Cohort/treatment group was the participant assigned to (if known)?</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-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> mae5.8_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Patient's treatment strategy assignment, if 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-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\"/> mae5.9</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Participant dosed or received study agent</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.mae5.9\">4 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\"/> mae5.9_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Did the participant receive the investigational agent? If answer is unknown due to blinding, select No Information.</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\"/> mae5.10</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">What study agent was received:</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.mae5.10\">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_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\"/> mae5.10_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">investigational agent or placebo or blinded 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_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\"/> mae5.11</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Were there any Protocol Deviations/Violations/Exceptions for this participant?</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.mae5.11\">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\"/> mae5.11_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 adverse medical event occurred with protocol deviation, violation, exception</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_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: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> mae5.12</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Describe the Protocol Deviations/Violations/Exceptions</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_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: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> mae5.12_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 protocol deviations, violations, or exceptions that occurred for this participant</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\"/> mae6</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Adverse Medical Event Information</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-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> mae6.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Submission 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-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.mae6.1\">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\"/> mae6.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Type of adverse event report being submitted</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\"/> mae6.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Start 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\"/> mae6.2_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 adverse event started</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\"/> mae6.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Reported 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\"/> mae6.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date 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-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\"/> mae6.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Recorded 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\"/> mae6.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date this adverse event was first recorded</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\"/> mae6.5a</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Narrative of the 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-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_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\"/> mae6.5a_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Provide a discussion of the Adverse Event. If a Serious Medical Event, narrative must provide a description of the SAE including chronological clinical presentation and evolution of the SAE and associated signs/symptoms). Serious Medical Event criteria are defined in the 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-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\"/> mae6.5b</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Medical Description of 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-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_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\"/> mae6.5b_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Diagnosis associated with adverse event. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.</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\"/> mae6.6</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is the Adverse Medical event still ongoing?</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.mae6.6\">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_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\"/> mae6.6_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator if adverse event is still continuing</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\"/> mae6.7</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Stop 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\">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\"/> mae6.7_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date that the event resolved</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\"/> mae6.8</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was the event expected?</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.mae6.8\">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_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\"/> mae6.8_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Adverse event was expected or not</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\"/> mae6.9</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Severity</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.mae6.9\">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\"/> mae6.9_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Physician assessment using sponsor defined categories</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\"/> mae6.10</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is the Adverse Medical Event Serious?</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.mae6.10\">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\"/> mae6.10_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 if an undesirable experience is associated with use of a medical product</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\"/> mae6.11</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Seriousness</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.mae6.11\">9 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\"/> mae6.11_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Serious criteria are defined in the 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-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\"/> mae6.11b</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Other-specify</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\"/> mae6.11b_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 other serious consequences or other medically important condition</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\"/> mae6.12</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">What is the date Adverse Medical Event became serious?</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\">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\"/> mae6.12_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date adverse event qualified as serious</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\"/> mae6.13</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Outcome of Adverse 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-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.mae6.13\">7 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\"/> mae6.13_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Participant's status after the 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-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> mae6.14</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was autopsy 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\">Enable When: <br/>Options: <a href=\"#opt-item.mae6.14\">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\"/> mae6.14_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 participant was autopsied</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\"/> mae6.15</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Relationship of Adverse Medical Event to Study Intervention</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.mae6.15\">5 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\"/> mae6.16</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 relationship with study intervention</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\"/> mae6.16_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 relationship between study intervention and 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\"/> mae6.17</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">What are possible alternate causes of the SAE?</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.mae6.17\">6 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\"/> mae6.17_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 possible alternative serious adverse event causes</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-text.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> mae6.18</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Study Procedure-specify</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\"/> mae6.18_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Study procedure associated with SAE</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-text.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> mae6.19</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Pre-existing condition-specify</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\"/> mae6.19_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Pre-existing condition associated with SAE</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-text.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> mae6.20</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Underlying disease-specify</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\"/> mae6.20_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Underlying disease associated with SAE</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-text.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> mae6.21</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Concomittant medication-specify</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\"/> mae6.21_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Concomitant medication associated with SAE</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-text.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> mae6.22</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Other known or suspected cause-specify</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\"/> mae6.22_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 causal reason was associated with SAE</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\"/> mae6.23</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Action Taken Regarding Study Intervention</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.mae6.23\">6 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\"/> mae6.23_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Changes to study intervention made after adverse event was detected</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-text.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Text\" class=\"hierarchy\"/> mae6.23b</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Other-specify</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\"/> mae6.23b_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Describe other changes to intervention made after adverse event was detected</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\"/> mae6.24</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did AE diminish/abate?</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.mae6.24\">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_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\"/> mae6.24_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 event diminished/abated after study intervention was discontinued, interrupted, or dose reduced (dechallenged)</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\"/> mae6.25</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If study intervention was restarted (rechallenge) did AE recur?</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.mae6.25\">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_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\"/> mae6.25_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 event recurred when the study intervention was restarted</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\"/> mae6.26</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Did the participant receive any relevant concomitant medications in response to the SAE?</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.mae6.26\">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_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\"/> mae6.27</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">SAE Concomitant Medications</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</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_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-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> mae6.27_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Concomitant medication associated with SAE</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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae6.28.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Medication 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_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\"/> mae6.28.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Name of concomitant medication given to participant in response to SAE</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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae6.28.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indication</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_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\"/> mae6.28.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indication for giving the concomitant medication to participant</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\"/> mae6.28.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Start 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\"/> mae6.28.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Start date for the concomitant medication given to participant</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\"/> mae6.28.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Stop 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\"/> mae6.28.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Stop date for the concomitant medication given to the participant</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-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> mae6.28.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Ongoing</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.mae6.28.5\">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_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\"/> mae6.28.5_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is concomitant medication administration for participant ongoing?</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\"/> mae6.29</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Did the participant receive any treatments/procedures in response to the SAE?</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-open-choice\">open-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.mae6.29\">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\"/> mae6.29_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Treatments/procedures administered in response to  SAE</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\"/> mae6.30</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">SAE Treatments/Procedures</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</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_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-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> mae6.30_help</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 SAE treatment/procedure participant received</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_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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae6.30.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Treatment/Procedure</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_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: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> mae6.30.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Name of SAE treatment/procedure participant received</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_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: white; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> mae6.30.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Start 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_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: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> mae6.30.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Start date for SAE treatment/procedure participant received</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_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: white; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> mae6.30.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Stop 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_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: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> mae6.30.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Stop date for SAE treatment/procedure participant received</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_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-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> mae6.30.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Ongoing</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.mae6.30.4\">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_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: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> mae6.30.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is the SAE treatment/procedure for the participant ongoing</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-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> mae7</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?</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-open-choice\">open-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.mae7\">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_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-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> mae7_help</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 laboratory or diagnostic tests administered to the participant in response to the SAE?</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\"/> mae8</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">SAE Laboratory or Diagnostic Tests</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</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_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\"/> mae8_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Laboratory or diagnostic tests obtained in response to AE</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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae8.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Lab/Diagnostic Test</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_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-date.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> mae8.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date</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_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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae8.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Result</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_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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae8.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Low Range</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_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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae8.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">High Range</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_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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> mae8.6</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Comments</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_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 = mae</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.mae1.3\"> </a><p><b>Answer options for mae1.3</b></p><ul><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: INT (&quot;Interventional&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: OBS (&quot;Observational&quot;)</li></ul><a name=\"opt-item.mae1.4\"> </a><p><b>Answer options for mae1.4</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.mae1.5\"> </a><p><b>Answer options for mae1.5</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.mae5.3\"> </a><p><b>Answer options for mae5.3</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0001.html\">http://terminology.hl7.org/CodeSystem/v2-0001</a>: F (&quot;Female&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0001.html\">http://terminology.hl7.org/CodeSystem/v2-0001</a>: M (&quot;Male&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0001.html\">http://terminology.hl7.org/CodeSystem/v2-0001</a>: O (&quot;Other&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0001.html\">http://terminology.hl7.org/CodeSystem/v2-0001</a>: U (&quot;Unknown&quot;)</li></ul><a name=\"opt-item.mae5.6\"> </a><p><b>Answer options for mae5.6</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v3-Ethnicity.html\">http://terminology.hl7.org/CodeSystem/v3-Ethnicity</a>: 2135-2 (&quot;Hispanic or Latino&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v3-Ethnicity.html\">http://terminology.hl7.org/CodeSystem/v3-Ethnicity</a>: 2186-5 (&quot;Not Hispanic or Latino&quot;)</li></ul><a name=\"opt-item.mae5.7\"> </a><p><b>Answer options for mae5.7</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v3-Race.html\">http://terminology.hl7.org/CodeSystem/v3-Race</a>: 2028-9 (&quot;Asian&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v3-Race.html\">http://terminology.hl7.org/CodeSystem/v3-Race</a>: 1002-5 (&quot;American Indian or Alaska Native&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v3-Race.html\">http://terminology.hl7.org/CodeSystem/v3-Race</a>: 2054-5 (&quot;Black or African American&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v3-Race.html\">http://terminology.hl7.org/CodeSystem/v3-Race</a>: 2076-8 (&quot;Native Hawaiian or Other Pacific Islander&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v3-Race.html\">http://terminology.hl7.org/CodeSystem/v3-Race</a>: 2106-3 (&quot;White&quot;)</li></ul><a name=\"opt-item.mae5.9\"> </a><p><b>Answer options for mae5.9</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><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>: NI (&quot;No Information&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>: NA (&quot;not applicable&quot;)</li></ul><a name=\"opt-item.mae5.10\"> </a><p><b>Answer options for mae5.10</b></p><ul><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: SA (&quot;Study Agent&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: PLACEBO (&quot;Placebo&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: BSA (&quot;Blinded Study Agent&quot;)</li></ul><a name=\"opt-item.mae5.11\"> </a><p><b>Answer options for mae5.11</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.mae6.1\"> </a><p><b>Answer options for mae6.1</b></p><ul><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: INITIAL (&quot;Initial&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: UPDATE (&quot;Update&quot;)</li></ul><a name=\"opt-item.mae6.6\"> </a><p><b>Answer options for mae6.6</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.mae6.8\"> </a><p><b>Answer options for mae6.8</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0239.html\">http://terminology.hl7.org/CodeSystem/v2-0239</a>: Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0239.html\">http://terminology.hl7.org/CodeSystem/v2-0239</a>: N (&quot;No&quot;)</li></ul><a name=\"opt-item.mae6.9\"> </a><p><b>Answer options for mae6.9</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-adverse-event-severity.html\">http://terminology.hl7.org/CodeSystem/adverse-event-severity</a>: mild (&quot;Mild&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-adverse-event-severity.html\">http://terminology.hl7.org/CodeSystem/adverse-event-severity</a>: moderate (&quot;Moderate&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-adverse-event-severity.html\">http://terminology.hl7.org/CodeSystem/adverse-event-severity</a>: severe (&quot;Severe&quot;)</li></ul><a name=\"opt-item.mae6.10\"> </a><p><b>Answer options for mae6.10</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-adverse-event-seriousness.html\">http://terminology.hl7.org/CodeSystem/adverse-event-seriousness</a>: serious (&quot;Serious&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-adverse-event-seriousness.html\">http://terminology.hl7.org/CodeSystem/adverse-event-seriousness</a>: non-serious (&quot;Non-serious&quot;)</li></ul><a name=\"opt-item.mae6.11\"> </a><p><b>Answer options for mae6.11</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html\">http://terminology.hl7.org/CodeSystem/v2-0240</a>: D (&quot;Death&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html\">http://terminology.hl7.org/CodeSystem/v2-0240</a>: L (&quot;Life threatening&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html\">http://terminology.hl7.org/CodeSystem/v2-0240</a>: H (&quot;Caused hospitalized&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html\">http://terminology.hl7.org/CodeSystem/v2-0240</a>: P (&quot;Prolonged hospitalization&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html\">http://terminology.hl7.org/CodeSystem/v2-0240</a>: O (&quot;Other&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html\">http://terminology.hl7.org/CodeSystem/v2-0240</a>: C (&quot;Congenital anomaly/birth defect&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html\">http://terminology.hl7.org/CodeSystem/v2-0240</a>: I (&quot;Incapacity which is significant, persistent or permanent&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html\">http://terminology.hl7.org/CodeSystem/v2-0240</a>: J (&quot;Disability which is significant, persistent or permanent&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html\">http://terminology.hl7.org/CodeSystem/v2-0240</a>: R (&quot;Required intervention to prevent permanent impairment/damage&quot;)</li></ul><a name=\"opt-item.mae6.13\"> </a><p><b>Answer options for mae6.13</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0241.html\">http://terminology.hl7.org/CodeSystem/v2-0241</a>: F (&quot;Fully recovered&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0241.html\">http://terminology.hl7.org/CodeSystem/v2-0241</a>: R (&quot;Recovering&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0241.html\">http://terminology.hl7.org/CodeSystem/v2-0241</a>: N (&quot;Not recovering/unchanged&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0241.html\">http://terminology.hl7.org/CodeSystem/v2-0241</a>: S (&quot;Sequelae&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0241.html\">http://terminology.hl7.org/CodeSystem/v2-0241</a>: D (&quot;Died&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0241.html\">http://terminology.hl7.org/CodeSystem/v2-0241</a>: W (&quot;Worsening&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0241.html\">http://terminology.hl7.org/CodeSystem/v2-0241</a>: U (&quot;Unknown&quot;)</li></ul><a name=\"opt-item.mae6.14\"> </a><p><b>Answer options for mae6.14</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><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>: UNK (&quot;Unknown&quot;)</li></ul><a name=\"opt-item.mae6.15\"> </a><p><b>Answer options for mae6.15</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0250.html\">http://terminology.hl7.org/CodeSystem/v2-0250</a>: N (&quot;Not related&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0250.html\">http://terminology.hl7.org/CodeSystem/v2-0250</a>: I (&quot;Improbable&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0250.html\">http://terminology.hl7.org/CodeSystem/v2-0250</a>: S (&quot;Somewhat probable&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0250.html\">http://terminology.hl7.org/CodeSystem/v2-0250</a>: M (&quot;Moderately probable&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0250.html\">http://terminology.hl7.org/CodeSystem/v2-0250</a>: H (&quot;Highly probable&quot;)</li></ul><a name=\"opt-item.mae6.17\"> </a><p><b>Answer options for mae6.17</b></p><ul><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: PRMYDIS (&quot;Primary disease&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: STDYPRO (&quot;Study Procedure&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: PRE (&quot;Pre-existing condition&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: UNDERLYINGDIS (&quot;Underlying disease&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: CONCMITMED (&quot;Concomitant medication&quot;)</li><li style=\"font-size: 11px\"><a href=\"CodeSystem-temporarycodes.html\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: OTHERCAUSE (&quot;Other known or suspected cause&quot;)</li></ul><a name=\"opt-item.mae6.23\"> </a><p><b>Answer options for mae6.23</b></p><ul><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0251.html\">http://terminology.hl7.org/CodeSystem/v2-0251</a>: N (&quot;None&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0251.html\">http://terminology.hl7.org/CodeSystem/v2-0251</a>: WP (&quot;Product withdrawn permanently&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0251.html\">http://terminology.hl7.org/CodeSystem/v2-0251</a>: WT (&quot;Product withdrawn temporarily&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0251.html\">http://terminology.hl7.org/CodeSystem/v2-0251</a>: DR (&quot;Product dose or frequency of use reduced&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0251.html\">http://terminology.hl7.org/CodeSystem/v2-0251</a>: DI (&quot;Product dose or frequency of use increased&quot;)</li><li style=\"font-size: 11px\"><a href=\"https://terminology.hl7.org/1.0.0//CodeSystem-v2-0251.html\">http://terminology.hl7.org/CodeSystem/v2-0251</a>: OT (&quot;Other&quot;)</li></ul><a name=\"opt-item.mae6.24\"> </a><p><b>Answer options for mae6.24</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><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>: NA (&quot;not applicable&quot;)</li></ul><a name=\"opt-item.mae6.25\"> </a><p><b>Answer options for mae6.25</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><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>: NA (&quot;not applicable&quot;)</li></ul><a name=\"opt-item.mae6.26\"> </a><p><b>Answer options for mae6.26</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.mae6.28.5\"> </a><p><b>Answer options for mae6.28.5</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.mae6.29\"> </a><p><b>Answer options for mae6.29</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.mae6.30.4\"> </a><p><b>Answer options for mae6.30.4</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.mae7\"> </a><p><b>Answer options for mae7</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>"
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       fhir:Expression.expression [ fhir:value "https://docr-fhir.dev.cloud.duke.edu/hapi-fhir-jpaserver/fhir/QuestionnaireResponse/QRIDInitiateStudy" ]     ]
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  fhir:Questionnaire.url [ fhir:value "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire"];
  fhir:Questionnaire.version [ fhir:value "0.1.0"];
  fhir:Questionnaire.name [ fhir:value "AE_Questionnaire"];
  fhir:Questionnaire.title [ fhir:value "Adverse Medical Event Questionnaire"];
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  fhir:Questionnaire.subjectType [
     fhir:value "ResearchStudy";
     fhir:index 0
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  fhir:Questionnaire.date [ fhir:value "2021-08-10T13:15:03+00:00"^^xsd:dateTime];
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  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" ]     ]
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       fhir:Coding.display [ fhir:value "United States of America" ]     ];
     fhir:CodeableConcept.text [ fhir:value "United States of America" ]
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  fhir:Questionnaire.item [
     fhir:index 0;
     fhir:Questionnaire.item.linkId [ fhir:value "mae1" ];
     fhir:Questionnaire.item.text [ fhir:value "RESEARCH STUDY" ];
     fhir:Questionnaire.item.type [ fhir:value "group" ];
     fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
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       fhir:Questionnaire.item.linkId [ fhir:value "mae1.1" ];
       fhir:Questionnaire.item.text [ fhir:value "Study Title" ];
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       fhir:Questionnaire.item.linkId [ fhir:value "mae1.4" ];
       fhir:Questionnaire.item.text [ fhir:value "Does this protocol require an FDA exemption?" ];
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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 "mae1.4_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator for use of FDA regulated product" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 4;
       fhir:Questionnaire.item.linkId [ fhir:value "mae1.5" ];
       fhir:Questionnaire.item.text [ fhir:value "Is an IND or IDE being used in this study?" ];
       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 "mae1.5_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 5;
       fhir:Questionnaire.item.linkId [ fhir:value "mae1.6" ];
       fhir:Questionnaire.item.text [ fhir:value "IND/IDE Number" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae1.5" ];
         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.required [ fhir:value "false"^^xsd:boolean ]     ]
  ], [
     fhir:index 1;
     fhir:Questionnaire.item.linkId [ fhir:value "mae2" ];
     fhir:Questionnaire.item.text [ fhir:value "Site Principal Investigator" ];
     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 "mae2.1" ];
       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 "mae2.1_help" ];
         fhir:Questionnaire.item.text [ fhir:value "First or given name associated with the site principal investigator" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 1;
       fhir:Questionnaire.item.linkId [ fhir:value "mae2.2" ];
       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.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 "mae2.2_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Surname or family name associated with the site principal investigator" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 2;
       fhir:Questionnaire.item.linkId [ fhir:value "mae2.5" ];
       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 "mae2.5_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the site principal investigator's name" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 3;
       fhir:Questionnaire.item.linkId [ fhir:value "mae2.6" ];
       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 "mae2.6_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Professional and Academic degrees associated with the site investigator" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 4;
       fhir:Questionnaire.item.linkId [ fhir:value "mae2.3" ];
       fhir:Questionnaire.item.text [ fhir:value "Phone" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]     ], [
       fhir:index 5;
       fhir:Questionnaire.item.linkId [ fhir:value "mae2.4" ];
       fhir:Questionnaire.item.text [ fhir:value "Email" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]     ]
  ], [
     fhir:index 2;
     fhir:Questionnaire.item.linkId [ fhir:value "mae3" ];
     fhir:Questionnaire.item.text [ fhir:value "Primary Contact" ];
     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 "mae3_help" ];
       fhir:Questionnaire.item.text [ fhir:value "Personnel completing the adverse event documentation at the relying site" ];
       fhir:Questionnaire.item.type [ fhir:value "display" ]     ], [
       fhir:index 1;
       fhir:Questionnaire.item.linkId [ fhir:value "mae3.1" ];
       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.repeats [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.readOnly [ fhir:value "false"^^xsd:boolean ]     ], [
       fhir:index 2;
       fhir:Questionnaire.item.linkId [ fhir:value "mae3.2" ];
       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:index 3;
       fhir:Questionnaire.item.linkId [ fhir:value "mae3.3" ];
       fhir:Questionnaire.item.text [ fhir:value "Phone" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]     ], [
       fhir:index 4;
       fhir:Questionnaire.item.linkId [ fhir:value "mae3.4" ];
       fhir:Questionnaire.item.text [ fhir:value "Email" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]     ]
  ], [
     fhir:index 3;
     fhir:Questionnaire.item.linkId [ fhir:value "mae4" ];
     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 "mae4_help" ];
       fhir:Questionnaire.item.text [ fhir:value "Location where adverse event is recorded" ];
       fhir:Questionnaire.item.type [ fhir:value "display" ]     ], [
       fhir:index 1;
       fhir:Questionnaire.item.linkId [ fhir:value "mae4.1" ];
       fhir:Questionnaire.item.text [ fhir:value "Name of organization/site where the event occurred" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]     ], [
       fhir:index 2;
       fhir:Questionnaire.item.linkId [ fhir:value "mae4.2" ];
       fhir:Questionnaire.item.text [ fhir:value "Name of organization/site which is recording the Adverse Medical event" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]     ]
  ], [
     fhir:index 4;
     fhir:Questionnaire.item.linkId [ fhir:value "mae5" ];
     fhir:Questionnaire.item.text [ fhir:value "Participant Information" ];
     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 "mae5.1" ];
       fhir:Questionnaire.item.text [ fhir:value "Patient ID" ];
       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 "mae5.1_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Participant identifier from study case report form" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 1;
       fhir:Questionnaire.item.linkId [ fhir:value "mae5.2" ];
       fhir:Questionnaire.item.text [ fhir:value "Age" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]     ], [
       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 "mae5.3" ];
       fhir:Questionnaire.item.text [ fhir:value "Birth Sex" ];
       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/v2-0001" ];
           fhir:Coding.code [ fhir:value "F" ];
           fhir:Coding.display [ fhir:value "Female" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0001" ];
           fhir:Coding.code [ fhir:value "M" ];
           fhir:Coding.display [ fhir:value "Male" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0001" ];
           fhir:Coding.code [ fhir:value "O" ];
           fhir:Coding.display [ fhir:value "Other" ]         ]       ], [
         fhir:index 3;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0001" ];
           fhir:Coding.code [ fhir:value "U" ];
           fhir:Coding.display [ fhir:value "Unknown" ]         ]       ]     ], [
       fhir:index 3;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption" ];
         fhir:Extension.valueCoding [
           fhir:Coding.display [ fhir:value "[lb]" ]         ]       ], [
         fhir:index 1;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption" ];
         fhir:Extension.valueCoding [
           fhir:Coding.display [ fhir:value "[kg]" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "mae5.4" ];
       fhir:Questionnaire.item.text [ fhir:value "Weight" ];
       fhir:Questionnaire.item.type [ fhir:value "quantity" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]     ], [
       fhir:index 4;
       fhir:Element.extension [
         fhir:index 0;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption" ];
         fhir:Extension.valueCoding [
           fhir:Coding.display [ fhir:value "[in]" ]         ]       ], [
         fhir:index 1;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption" ];
         fhir:Extension.valueCoding [
           fhir:Coding.display [ fhir:value "[ft]" ]         ]       ], [
         fhir:index 2;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption" ];
         fhir:Extension.valueCoding [
           fhir:Coding.display [ fhir:value "[cm]" ]         ]       ], [
         fhir:index 3;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption" ];
         fhir:Extension.valueCoding [
           fhir:Coding.display [ fhir:value "[m]" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "mae5.5" ];
       fhir:Questionnaire.item.text [ fhir:value "Height" ];
       fhir:Questionnaire.item.type [ fhir:value "quantity" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]     ], [
       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 "mae5.6" ];
       fhir:Questionnaire.item.text [ fhir:value "Ethnicity" ];
       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.answerOption [
         fhir:index 0;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v3-Ethnicity" ];
           fhir:Coding.code [ fhir:value "2135-2" ];
           fhir:Coding.display [ fhir:value "Hispanic or Latino" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v3-Ethnicity" ];
           fhir:Coding.code [ fhir:value "2186-5" ];
           fhir:Coding.display [ fhir:value "Not Hispanic or Latino" ]         ]       ]     ], [
       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 "check-box" ];
             fhir:Coding.display [ fhir:value "Check-box" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Check-box" ]         ]       ], [
         fhir:index 1;
         fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation" ];
         fhir:Extension.valueCode [ fhir:value "vertical" ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "mae5.7" ];
       fhir:Questionnaire.item.text [ fhir:value "Race" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.repeats [ fhir:value "true"^^xsd:boolean ];
       fhir:Questionnaire.item.answerOption [
         fhir:index 0;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v3-Race" ];
           fhir:Coding.code [ fhir:value "2028-9" ];
           fhir:Coding.display [ fhir:value "Asian" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v3-Race" ];
           fhir:Coding.code [ fhir:value "1002-5" ];
           fhir:Coding.display [ fhir:value "American Indian or Alaska Native" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v3-Race" ];
           fhir:Coding.code [ fhir:value "2054-5" ];
           fhir:Coding.display [ fhir:value "Black or African American" ]         ]       ], [
         fhir:index 3;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v3-Race" ];
           fhir:Coding.code [ fhir:value "2076-8" ];
           fhir:Coding.display [ fhir:value "Native Hawaiian or Other Pacific Islander" ]         ]       ], [
         fhir:index 4;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v3-Race" ];
           fhir:Coding.code [ fhir:value "2106-3" ];
           fhir:Coding.display [ fhir:value "White" ]         ]       ]     ], [
       fhir:index 7;
       fhir:Questionnaire.item.linkId [ fhir:value "mae5.8" ];
       fhir:Questionnaire.item.text [ fhir:value "Which Arm/Cohort/treatment group was the participant assigned to (if known)?" ];
       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 "mae5.8_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Patient's treatment strategy assignment, if known." ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 8;
       fhir:Questionnaire.item.linkId [ fhir:value "mae5.9" ];
       fhir:Questionnaire.item.text [ fhir:value "Participant dosed or received study agent" ];
       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:index 2;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "NI" ];
           fhir:Coding.display [ fhir:value "No Information" ]         ]       ], [
         fhir:index 3;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "NA" ];
           fhir:Coding.display [ fhir:value "not applicable" ]         ]       ];
       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 "mae5.9_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Did the participant receive the investigational agent? If answer is unknown due to blinding, select No Information." ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 9;
       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 "mae5.10" ];
       fhir:Questionnaire.item.text [ fhir:value "What study agent was received:" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae5.9" ];
         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:index 1;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae5.9" ];
         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 "NI" ]         ]       ];
       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://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "SA" ];
           fhir:Coding.display [ fhir:value "Study Agent" ]         ]       ], [
         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 "PLACEBO" ];
           fhir:Coding.display [ fhir:value "Placebo" ]         ]       ], [
         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 "BSA" ];
           fhir:Coding.display [ fhir:value "Blinded Study Agent" ]         ]       ];
       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 "mae5.10_help" ];
         fhir:Questionnaire.item.text [ fhir:value "investigational agent or placebo or blinded study" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 10;
       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 "mae5.11" ];
       fhir:Questionnaire.item.text [ fhir:value "Were there any Protocol Deviations/Violations/Exceptions for this participant?" ];
       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 "mae5.11_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator if adverse medical event occurred with protocol deviation, violation, exception" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 11;
       fhir:Questionnaire.item.linkId [ fhir:value "mae5.12" ];
       fhir:Questionnaire.item.text [ fhir:value "Describe the Protocol Deviations/Violations/Exceptions" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae5.11" ];
         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.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 "flyover" ]             ]           ]         ];
         fhir:Questionnaire.item.linkId [ fhir:value "mae5.12_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Description of protocol deviations, violations, or exceptions that occurred for this participant" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ]
  ], [
     fhir:index 5;
     fhir:Questionnaire.item.linkId [ fhir:value "mae6" ];
     fhir:Questionnaire.item.text [ fhir:value "Adverse Medical Event Information" ];
     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 "drop-down" ];
             fhir:Coding.display [ fhir:value "Drop down" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Drop down" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.1" ];
       fhir:Questionnaire.item.text [ fhir:value "Submission Type" ];
       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 "INITIAL" ];
           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 "UPDATE" ];
           fhir:Coding.display [ fhir:value "Update" ]         ]       ];
       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 "mae6.1_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Type of adverse event report being submitted" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 1;
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.2" ];
       fhir:Questionnaire.item.text [ fhir:value "Start 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 "mae6.2_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Date adverse event started" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 2;
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.3" ];
       fhir:Questionnaire.item.text [ fhir:value "Reported 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 "mae6.3_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Date of this report" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 3;
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.4" ];
       fhir:Questionnaire.item.text [ fhir:value "Recorded 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 "mae6.4_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Date this adverse event was first recorded" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 4;
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.5a" ];
       fhir:Questionnaire.item.text [ fhir:value "Narrative of the Adverse Event:" ];
       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 "mae6.5a_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Provide a discussion of the Adverse Event. If a Serious Medical Event, narrative must provide a description of the SAE including chronological clinical presentation and evolution of the SAE and associated signs/symptoms). Serious Medical Event criteria are defined in the protocol." ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 5;
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.5b" ];
       fhir:Questionnaire.item.text [ fhir:value "Medical Description of Adverse Event" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       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 "mae6.5b_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Diagnosis associated with adverse event. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related." ];
         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 "mae6.6" ];
       fhir:Questionnaire.item.text [ fhir:value "Is the Adverse Medical event still ongoing?" ];
       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 "mae6.6_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator if adverse event is still continuing" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 7;
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.7" ];
       fhir:Questionnaire.item.text [ fhir:value "Stop Date" ];
       fhir:Questionnaire.item.type [ fhir:value "date" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.6" ];
         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 "N" ]         ]       ];
       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 "mae6.7_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Date that the event resolved" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 8;
       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 "mae6.8" ];
       fhir:Questionnaire.item.text [ fhir:value "Was the event expected?" ];
       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/v2-0239" ];
           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/v2-0239" ];
           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 "mae6.8_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Adverse event was expected or not" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 9;
       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 "mae6.9" ];
       fhir:Questionnaire.item.text [ fhir:value "Severity" ];
       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/adverse-event-severity" ];
           fhir:Coding.code [ fhir:value "mild" ];
           fhir:Coding.display [ fhir:value "Mild" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/adverse-event-severity" ];
           fhir:Coding.code [ fhir:value "moderate" ];
           fhir:Coding.display [ fhir:value "Moderate" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/adverse-event-severity" ];
           fhir:Coding.code [ fhir:value "severe" ];
           fhir:Coding.display [ fhir:value "Severe" ]         ]       ];
       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 "mae6.9_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Physician assessment using sponsor defined categories" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 10;
       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 "mae6.10" ];
       fhir:Questionnaire.item.text [ fhir:value "Is the Adverse Medical Event Serious?" ];
       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/adverse-event-seriousness" ];
           fhir:Coding.code [ fhir:value "serious" ];
           fhir:Coding.display [ fhir:value "Serious" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness" ];
           fhir:Coding.code [ fhir:value "non-serious" ];
           fhir:Coding.display [ fhir:value "Non-serious" ]         ]       ];
       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 "mae6.10_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator if an undesirable experience is associated with use of a medical product" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 11;
       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 "mae6.11" ];
       fhir:Questionnaire.item.text [ fhir:value "Seriousness" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.10" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness" ];
           fhir:Coding.code [ fhir:value "serious" ]         ]       ];
       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/v2-0240" ];
           fhir:Coding.code [ fhir:value "D" ];
           fhir:Coding.display [ fhir:value "Death" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0240" ];
           fhir:Coding.code [ fhir:value "L" ];
           fhir:Coding.display [ fhir:value "Life threatening" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0240" ];
           fhir:Coding.code [ fhir:value "H" ];
           fhir:Coding.display [ fhir:value "Caused hospitalized" ]         ]       ], [
         fhir:index 3;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0240" ];
           fhir:Coding.code [ fhir:value "P" ];
           fhir:Coding.display [ fhir:value "Prolonged hospitalization" ]         ]       ], [
         fhir:index 4;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0240" ];
           fhir:Coding.code [ fhir:value "O" ];
           fhir:Coding.display [ fhir:value "Other" ]         ]       ], [
         fhir:index 5;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0240" ];
           fhir:Coding.code [ fhir:value "C" ];
           fhir:Coding.display [ fhir:value "Congenital anomaly/birth defect" ]         ]       ], [
         fhir:index 6;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0240" ];
           fhir:Coding.code [ fhir:value "I" ];
           fhir:Coding.display [ fhir:value "Incapacity which is significant, persistent or permanent" ]         ]       ], [
         fhir:index 7;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0240" ];
           fhir:Coding.code [ fhir:value "J" ];
           fhir:Coding.display [ fhir:value "Disability which is significant, persistent or permanent" ]         ]       ], [
         fhir:index 8;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0240" ];
           fhir:Coding.code [ fhir:value "R" ];
           fhir:Coding.display [ fhir:value "Required intervention to prevent permanent impairment/damage" ]         ]       ];
       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 "mae6.11_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Serious criteria are defined in the protocol" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 12;
       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 "mae6.11b" ];
       fhir:Questionnaire.item.text [ fhir:value "Other-specify" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.11" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0240" ];
           fhir:Coding.code [ fhir:value "O" ]         ]       ];
       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 "mae6.11b_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Describe other serious consequences or other medically important condition" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 13;
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.12" ];
       fhir:Questionnaire.item.text [ fhir:value "What is the date Adverse Medical Event became serious?" ];
       fhir:Questionnaire.item.type [ fhir:value "date" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.10" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness" ];
           fhir:Coding.code [ fhir:value "serious" ]         ]       ];
       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 "mae6.12_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Date adverse event qualified as serious" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 14;
       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 "mae6.13" ];
       fhir:Questionnaire.item.text [ fhir:value "Outcome of Adverse Medical Event" ];
       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/v2-0241" ];
           fhir:Coding.code [ fhir:value "F" ];
           fhir:Coding.display [ fhir:value "Fully recovered" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0241" ];
           fhir:Coding.code [ fhir:value "R" ];
           fhir:Coding.display [ fhir:value "Recovering" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0241" ];
           fhir:Coding.code [ fhir:value "N" ];
           fhir:Coding.display [ fhir:value "Not recovering/unchanged" ]         ]       ], [
         fhir:index 3;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0241" ];
           fhir:Coding.code [ fhir:value "S" ];
           fhir:Coding.display [ fhir:value "Sequelae" ]         ]       ], [
         fhir:index 4;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0241" ];
           fhir:Coding.code [ fhir:value "D" ];
           fhir:Coding.display [ fhir:value "Died" ]         ]       ], [
         fhir:index 5;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0241" ];
           fhir:Coding.code [ fhir:value "W" ];
           fhir:Coding.display [ fhir:value "Worsening" ]         ]       ], [
         fhir:index 6;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0241" ];
           fhir:Coding.code [ fhir:value "U" ];
           fhir:Coding.display [ fhir:value "Unknown" ]         ]       ];
       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 "mae6.13_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Participant's status after the adverse event" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 15;
       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 "mae6.14" ];
       fhir:Questionnaire.item.text [ fhir:value "Was autopsy performed?" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.13" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0241" ];
           fhir:Coding.code [ fhir:value "D" ]         ]       ];
       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:index 2;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "UNK" ];
           fhir:Coding.display [ fhir:value "Unknown" ]         ]       ];
       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 "mae6.14_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Indicator if participant was autopsied" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 16;
       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 "mae6.15" ];
       fhir:Questionnaire.item.text [ fhir:value "Relationship of Adverse Medical Event to Study Intervention" ];
       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/v2-0250" ];
           fhir:Coding.code [ fhir:value "N" ];
           fhir:Coding.display [ fhir:value "Not related" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0250" ];
           fhir:Coding.code [ fhir:value "I" ];
           fhir:Coding.display [ fhir:value "Improbable" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0250" ];
           fhir:Coding.code [ fhir:value "S" ];
           fhir:Coding.display [ fhir:value "Somewhat probable" ]         ]       ], [
         fhir:index 3;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0250" ];
           fhir:Coding.code [ fhir:value "M" ];
           fhir:Coding.display [ fhir:value "Moderately probable" ]         ]       ], [
         fhir:index 4;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0250" ];
           fhir:Coding.code [ fhir:value "H" ];
           fhir:Coding.display [ fhir:value "Highly probable" ]         ]       ]     ], [
       fhir:index 17;
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.16" ];
       fhir:Questionnaire.item.text [ fhir:value "Rationale for relationship with study intervention" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.15" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0250" ];
           fhir:Coding.code [ fhir:value "S" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.15" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0250" ];
           fhir:Coding.code [ fhir:value "M" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.15" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0250" ];
           fhir:Coding.code [ fhir:value "H" ]         ]       ];
       fhir:Questionnaire.item.enableBehavior [ fhir:value "any" ];
       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 "mae6.16_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Explanation for relationship between study intervention and adverse event" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 18;
       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 "mae6.17" ];
       fhir:Questionnaire.item.text [ fhir:value "What are possible alternate causes of the SAE?" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.15" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0250" ];
           fhir:Coding.code [ fhir:value "N" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.15" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0250" ];
           fhir:Coding.code [ fhir:value "I" ]         ]       ];
       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://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "PRMYDIS" ];
           fhir:Coding.display [ fhir:value "Primary disease" ]         ]       ], [
         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 "STDYPRO" ];
           fhir:Coding.display [ fhir:value "Study Procedure" ]         ]       ], [
         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 "PRE" ];
           fhir:Coding.display [ fhir:value "Pre-existing condition" ]         ]       ], [
         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 "UNDERLYINGDIS" ];
           fhir:Coding.display [ fhir:value "Underlying disease" ]         ]       ], [
         fhir:index 4;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "CONCMITMED" ];
           fhir:Coding.display [ fhir:value "Concomitant medication" ]         ]       ], [
         fhir:index 5;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
           fhir:Coding.code [ fhir:value "OTHERCAUSE" ];
           fhir:Coding.display [ fhir:value "Other known or suspected cause" ]         ]       ];
       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 "mae6.17_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Reason for possible alternative serious adverse event causes" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 19;
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.18" ];
       fhir:Questionnaire.item.text [ fhir:value "Study Procedure-specify" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.17" ];
         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 "STDYPRO" ]         ]       ];
       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 "mae6.18_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Study procedure associated with SAE" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 20;
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.19" ];
       fhir:Questionnaire.item.text [ fhir:value "Pre-existing condition-specify" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.17" ];
         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 "PRE" ]         ]       ];
       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 "mae6.19_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Pre-existing condition associated with SAE" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 21;
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.20" ];
       fhir:Questionnaire.item.text [ fhir:value "Underlying disease-specify" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.17" ];
         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 "UNDERLYINGDIS" ]         ]       ];
       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 "mae6.20_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Underlying disease associated with SAE" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 22;
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.21" ];
       fhir:Questionnaire.item.text [ fhir:value "Concomittant medication-specify" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.17" ];
         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 "CONCMITMED" ]         ]       ];
       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 "mae6.21_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Concomitant medication associated with SAE" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 23;
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.22" ];
       fhir:Questionnaire.item.text [ fhir:value "Other known or suspected cause-specify" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.17" ];
         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 "OTHERCAUSE" ]         ]       ];
       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 "mae6.22_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Other causal reason was associated with SAE" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 24;
       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 "mae6.23" ];
       fhir:Questionnaire.item.text [ fhir:value "Action Taken Regarding Study Intervention" ];
       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/v2-0251" ];
           fhir:Coding.code [ fhir:value "N" ];
           fhir:Coding.display [ fhir:value "None" ]         ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0251" ];
           fhir:Coding.code [ fhir:value "WP" ];
           fhir:Coding.display [ fhir:value "Product withdrawn permanently" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0251" ];
           fhir:Coding.code [ fhir:value "WT" ];
           fhir:Coding.display [ fhir:value "Product withdrawn temporarily" ]         ]       ], [
         fhir:index 3;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0251" ];
           fhir:Coding.code [ fhir:value "DR" ];
           fhir:Coding.display [ fhir:value "Product dose or frequency of use reduced" ]         ]       ], [
         fhir:index 4;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0251" ];
           fhir:Coding.code [ fhir:value "DI" ];
           fhir:Coding.display [ fhir:value "Product dose or frequency of use increased" ]         ]       ], [
         fhir:index 5;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0251" ];
           fhir:Coding.code [ fhir:value "OT" ];
           fhir:Coding.display [ fhir:value "Other" ]         ]       ];
       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 "mae6.23_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Changes to study intervention made after adverse event was detected" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 25;
       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 "mae6.23b" ];
       fhir:Questionnaire.item.text [ fhir:value "Other-specify" ];
       fhir:Questionnaire.item.type [ fhir:value "text" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.23" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0251" ];
           fhir:Coding.code [ fhir:value "OT" ]         ]       ];
       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 "mae6.23b_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Describe other changes to intervention made after adverse event was detected" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 26;
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.24" ];
       fhir:Questionnaire.item.text [ fhir:value "If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did AE diminish/abate?" ];
       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:index 2;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "NA" ];
           fhir:Coding.display [ fhir:value "not applicable" ]         ]       ];
       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 "mae6.24_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Adverse event diminished/abated after study intervention was discontinued, interrupted, or dose reduced (dechallenged)" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 27;
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.25" ];
       fhir:Questionnaire.item.text [ fhir:value "If study intervention was restarted (rechallenge) did AE recur?" ];
       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:index 2;
         fhir:Questionnaire.item.answerOption.valueCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
           fhir:Coding.code [ fhir:value "NA" ];
           fhir:Coding.display [ fhir:value "not applicable" ]         ]       ];
       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 "mae6.25_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Adverse event recurred when the study intervention was restarted" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 28;
       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 "mae6.26" ];
       fhir:Questionnaire.item.text [ fhir:value "Did the participant receive any relevant concomitant medications in response to the SAE?" ];
       fhir:Questionnaire.item.type [ fhir:value "choice" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.10" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness" ];
           fhir:Coding.code [ fhir:value "serious" ]         ]       ];
       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:index 29;
       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 "gtable" ];
             fhir:Coding.display [ fhir:value "Group Table" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Group Table" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.27" ];
       fhir:Questionnaire.item.text [ fhir:value "SAE Concomitant Medications" ];
       fhir:Questionnaire.item.type [ fhir:value "group" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.26" ];
         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.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.repeats [ fhir:value "true"^^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 "mae6.27_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Concomitant medication associated with SAE" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.linkId [ fhir:value "mae6.28.1" ];
         fhir:Questionnaire.item.text [ fhir:value "Medication 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 "mae6.28.1_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Name of concomitant medication given to participant in response to SAE" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.linkId [ fhir:value "mae6.28.2" ];
         fhir:Questionnaire.item.text [ fhir:value "Indication" ];
         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 "mae6.28.2_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Indication for giving the concomitant medication to participant" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 3;
         fhir:Questionnaire.item.linkId [ fhir:value "mae6.28.3" ];
         fhir:Questionnaire.item.text [ fhir:value "Start 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 "mae6.28.3_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Start date for the concomitant medication given to participant" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 4;
         fhir:Questionnaire.item.linkId [ fhir:value "mae6.28.4" ];
         fhir:Questionnaire.item.text [ fhir:value "Stop 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 "mae6.28.4_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Stop date for the concomitant medication given to the participant" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 5;
         fhir:Questionnaire.item.linkId [ fhir:value "mae6.28.5" ];
         fhir:Questionnaire.item.text [ fhir:value "Ongoing" ];
         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 "mae6.28.5_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Is concomitant medication administration for participant ongoing?" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ]     ], [
       fhir:index 30;
       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 "mae6.29" ];
       fhir:Questionnaire.item.text [ fhir:value "Did the participant receive any treatments/procedures in response to the SAE?" ];
       fhir:Questionnaire.item.type [ fhir:value "open-choice" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.10" ];
         fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
         fhir:Questionnaire.item.enableWhen.answerCoding [
           fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness" ];
           fhir:Coding.code [ fhir:value "serious" ]         ]       ];
       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 "mae6.29_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Treatments/procedures administered in response to  SAE" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ]     ], [
       fhir:index 31;
       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 "gtable" ];
             fhir:Coding.display [ fhir:value "Group Table" ]           ];
           fhir:CodeableConcept.text [ fhir:value "Group Table" ]         ]       ];
       fhir:Questionnaire.item.linkId [ fhir:value "mae6.30" ];
       fhir:Questionnaire.item.text [ fhir:value "SAE Treatments/Procedures" ];
       fhir:Questionnaire.item.type [ fhir:value "group" ];
       fhir:Questionnaire.item.enableWhen [
         fhir:index 0;
         fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.29" ];
         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.required [ fhir:value "false"^^xsd:boolean ];
       fhir:Questionnaire.item.repeats [ fhir:value "true"^^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 "mae6.30_help" ];
         fhir:Questionnaire.item.text [ fhir:value "Name of SAE treatment/procedure participant received" ];
         fhir:Questionnaire.item.type [ fhir:value "display" ]       ], [
         fhir:index 1;
         fhir:Questionnaire.item.linkId [ fhir:value "mae6.30.1" ];
         fhir:Questionnaire.item.text [ fhir:value "Treatment/Procedure" ];
         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 "mae6.30.1_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Name of SAE treatment/procedure participant received" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 2;
         fhir:Questionnaire.item.linkId [ fhir:value "mae6.30.2" ];
         fhir:Questionnaire.item.text [ fhir:value "Start 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 "mae6.30.2_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Start date for SAE treatment/procedure participant received" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 3;
         fhir:Questionnaire.item.linkId [ fhir:value "mae6.30.3" ];
         fhir:Questionnaire.item.text [ fhir:value "Stop 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 "mae6.30.3_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Stop date for SAE treatment/procedure participant received" ];
           fhir:Questionnaire.item.type [ fhir:value "display" ]         ]       ], [
         fhir:index 4;
         fhir:Questionnaire.item.linkId [ fhir:value "mae6.30.4" ];
         fhir:Questionnaire.item.text [ fhir:value "Ongoing" ];
         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 "mae6.30.4_help" ];
           fhir:Questionnaire.item.text [ fhir:value "Is the SAE treatment/procedure for the participant ongoing" ];
           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 "mae7" ];
     fhir:Questionnaire.item.text [ fhir:value "Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?" ];
     fhir:Questionnaire.item.type [ fhir:value "open-choice" ];
     fhir:Questionnaire.item.enableWhen [
       fhir:index 0;
       fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae6.10" ];
       fhir:Questionnaire.item.enableWhen.operator [ fhir:value "=" ];
       fhir:Questionnaire.item.enableWhen.answerCoding [
         fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness" ];
         fhir:Coding.code [ fhir:value "serious" ]       ]     ];
     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 "mae7_help" ];
       fhir:Questionnaire.item.text [ fhir:value "Were any laboratory or diagnostic tests administered to the participant in response to the SAE?" ];
       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 "gtable" ];
           fhir:Coding.display [ fhir:value "Group Table" ]         ];
         fhir:CodeableConcept.text [ fhir:value "Group Table" ]       ]     ];
     fhir:Questionnaire.item.linkId [ fhir:value "mae8" ];
     fhir:Questionnaire.item.text [ fhir:value "SAE Laboratory or Diagnostic Tests" ];
     fhir:Questionnaire.item.type [ fhir:value "group" ];
     fhir:Questionnaire.item.enableWhen [
       fhir:index 0;
       fhir:Questionnaire.item.enableWhen.question [ fhir:value "mae7" ];
       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.required [ fhir:value "false"^^xsd:boolean ];
     fhir:Questionnaire.item.repeats [ fhir:value "true"^^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 "mae8_help" ];
       fhir:Questionnaire.item.text [ fhir:value "Laboratory or diagnostic tests obtained in response to AE" ];
       fhir:Questionnaire.item.type [ fhir:value "display" ]     ], [
       fhir:index 1;
       fhir:Questionnaire.item.linkId [ fhir:value "mae8.1" ];
       fhir:Questionnaire.item.text [ fhir:value "Lab/Diagnostic Test" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]     ], [
       fhir:index 2;
       fhir:Questionnaire.item.linkId [ fhir:value "mae8.2" ];
       fhir:Questionnaire.item.text [ fhir:value "Date" ];
       fhir:Questionnaire.item.type [ fhir:value "date" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]     ], [
       fhir:index 3;
       fhir:Questionnaire.item.linkId [ fhir:value "mae8.3" ];
       fhir:Questionnaire.item.text [ fhir:value "Result" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]     ], [
       fhir:index 4;
       fhir:Questionnaire.item.linkId [ fhir:value "mae8.4" ];
       fhir:Questionnaire.item.text [ fhir:value "Low Range" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]     ], [
       fhir:index 5;
       fhir:Questionnaire.item.linkId [ fhir:value "mae8.5" ];
       fhir:Questionnaire.item.text [ fhir:value "High Range" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]     ], [
       fhir:index 6;
       fhir:Questionnaire.item.linkId [ fhir:value "mae8.6" ];
       fhir:Questionnaire.item.text [ fhir:value "Comments" ];
       fhir:Questionnaire.item.type [ fhir:value "string" ];
       fhir:Questionnaire.item.required [ fhir:value "false"^^xsd:boolean ]     ]
  ], [
     fhir:index 8;
     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 "mae" ]       ]     ], [
       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.