Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use
Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use
This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v1.0.0: STU 1) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions 
@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:QuestionnaireResponse ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "nme-populate-exampleQR"] ; # fhir:meta [ fhir:versionId [ fhir:v "1" ] ; fhir:lastUpdated [ fhir:v "2022-02-28T01:16:20.863+00:00"^^xsd:dateTime ] ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><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\">Definition</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\">Answer</a><span style=\"float: right\"><a href=\"http://hl7.org/fhir/R4/formats.html#table\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" 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=\"QuestionnaireResponseRoot\" class=\"hierarchy\"/> nme-populate-exampleQR</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\">QuestionnaireResponse</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></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\"/> nme1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Research Study</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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=\"Item\" class=\"hierarchy\"/> nme1.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Study Title</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Study of Drug A for arthritis</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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme1.3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #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\">PRO098765</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_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=\"Item\" class=\"hierarchy\"/> nme1.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Status</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span><span><a href=\"CodeSystem-temporarycodes.html#temporarycodes-nochange\">Temporary Codes</a> nochange: No change in research activities</span></span></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\"/> nme7</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Organization/Site</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme7.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Where Adverse Non-Medical Event Occurred</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme7.1.8</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 Adverse Non-Medical Event occur at the lead principal investigator site?</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\"><span><span><a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-N\">expandedYes-NoIndicator</a> N: No</span></span></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_bck1110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme7.1.11</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 Adverse Non-Medical Event occur at one of the relying sites?</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\"><span><span><a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-Y\">expandedYes-NoIndicator</a> Y: Yes</span></span></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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> ExternalDataFor_nme7.1.9</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">External Data For linkId nme7.1.9</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme7.1.9</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If the Adverse Non-Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the relying institution and relying site principal investigator details below.</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\"><span><span>[not stated] : Central Campus Test University | | Maria Smith, PhD | Central, MI</span></span></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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme7.1.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Name of organization/site where the Adverse Non-Medical Event occurred</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Central Campus Test University</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_bck1110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme7.1.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">City</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Central</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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme7.1.3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">State</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">MI</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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme7.1.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Country</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">United States</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_bck101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme7.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Responsibility for Adverse Non-Medical Event Reporting</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme7.2.8</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If the Adverse Non-Medical Event occurred at a relying site or at another organization (unrelated to the lead principal investigator organization/site or relying sites), will the lead principal investigator site be recording the Adverse Non-Medical Event?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span><span><a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-Y\">expandedYes-NoIndicator</a> Y: Yes</span></span></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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme7.2.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Name of organization/site which is recording the Adverse Non-Medical Event</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Sample University Medical Center</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_bck1010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme7.2.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">City</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Sample City</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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme7.2.3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">State</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">NC</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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme7.2.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Country</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">United States</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\"/> nme8</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 for the site where Adverse Non-Medical Event occurred</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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=\"Item\" class=\"hierarchy\"/> nme8.1</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\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Maria</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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme8.4</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\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Smith</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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme8.6</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\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">PhD</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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme8.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Phone</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\">8901231234</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_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=\"Item\" class=\"hierarchy\"/> nme8.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Email</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">maria.smith@CCTU.med.edu</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\"/> nme3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Report</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=\"Item\" class=\"hierarchy\"/> nme3.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Report Date</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">2022-02-27</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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Report Status</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\"><span><span><a href=\"CodeSystem-temporarycodes.html#temporarycodes-init\">Temporary Codes</a> init: Initial</span></span></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_bck101.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme3.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Select at least one of the following criteria:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">New information resulted in unexpected change in risks of the research</td><td style=\"vertical-align: top; text-align : left; background-color: #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\">true</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_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-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme3.3.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">New or increased risk</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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_bck10110.png)\" class=\"hierarchy\"><img src=\"tbl_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.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.5.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">2022-02-27</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_bck10110.png)\" class=\"hierarchy\"><img src=\"tbl_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.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.5.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date discovered:</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\">2022-02-26</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_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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.5.3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Description:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">[answer]</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_bck1010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.6</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Unanticipated Problem Involving Risk to Participants or Others</td><td style=\"vertical-align: top; text-align : left; background-color: 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\">true</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme3.3.7</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Unanticipated Problem</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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_bck10110.png)\" class=\"hierarchy\"><img src=\"tbl_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.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.7.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Event date:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">2022-02-26</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_bck10110.png)\" class=\"hierarchy\"><img src=\"tbl_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.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.7.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date event became aware to study team:</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\">2022-02-27</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_bck10110.png)\" class=\"hierarchy\"><img src=\"tbl_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.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.7.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Event Summary:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">[answer]</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_bck10110.png)\" class=\"hierarchy\"><img src=\"tbl_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.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.7.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was this event Unexpected?</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span><span><a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-Y\">expandedYes-NoIndicator</a> Y: Yes</span></span></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_bck10110.png)\" class=\"hierarchy\"><img src=\"tbl_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.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.7.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If yes, please explain:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">[answer]</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_bck10110.png)\" class=\"hierarchy\"><img src=\"tbl_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.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.7.6</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was this event Related or Possibly Related to participation in the research?</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span><span><a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-Y\">expandedYes-NoIndicator</a> Y: Yes</span></span></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_bck10110.png)\" class=\"hierarchy\"><img src=\"tbl_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.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.7.7</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If yes, please explain:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">[answer]</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_bck10110.png)\" class=\"hierarchy\"><img src=\"tbl_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.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.7.8</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Does this event suggest that the research places participant(s) or others at a greater Risk of harm than was previously known?</td><td style=\"vertical-align: top; text-align : left; background-color: #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\"><span><span><a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-Y\">expandedYes-NoIndicator</a> Y: Yes</span></span></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.7.9</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If yes, please explain:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">[answer]</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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.10</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">A breach of Confidentiality</td><td style=\"vertical-align: top; text-align : left; background-color: #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\">false</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_bck1010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.14</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team</td><td style=\"vertical-align: top; text-align : left; background-color: 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\">true</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_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-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme3.3.15</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Participant Complaint</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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_bck10010.png)\" class=\"hierarchy\"><img src=\"tbl_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.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.15.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Complaint Date:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">2022-02-27</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_bck10010.png)\" class=\"hierarchy\"><img src=\"tbl_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.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.15.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date received:</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\">2022-02-27</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme3.3.15.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Description:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">[answer]</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\"/> nme4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Reporting</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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=\"Item\" class=\"hierarchy\"/> nme4.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was the Sponsor notified?</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\"><span><span><a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-Y\">expandedYes-NoIndicator</a> Y: Yes</span></span></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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme4.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Notification date:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">2022-02-27</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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme4.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was the IRB notified?</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\"><span><span><a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-Y\">expandedYes-NoIndicator</a> Y: Yes</span></span></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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme4.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Notification date:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">2022-02-27</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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme4.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Were any Other Parties notified?</td><td style=\"vertical-align: top; text-align : left; background-color: 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\"><span><span><a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-Y\">expandedYes-NoIndicator</a> Y: Yes</span></span></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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme4.6</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">List other notified parties</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">[answer]</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Corrective and Preventative Action Plan</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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=\"Item\" class=\"hierarchy\"/> nme5.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was a Root Cause analysis performed?</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\"><span><span><a href=\"CodeSystem-temporarycodes.html#temporarycodes-pending\">Temporary Codes</a> pending: Pending - Currently under development</span></span></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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme5.2b</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If pending, describe status and interim findings, if any:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">[answer]</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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme5.3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was Corrective Action implemented?</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\"><span><span><a href=\"CodeSystem-temporarycodes.html#temporarycodes-pending\">Temporary Codes</a> pending: Pending - Currently under development</span></span></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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme5.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If Corrective Action was implemented or is pending, provide a summary:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">[answer]</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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme5.5</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was Preventitive Action implemented?</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\"><span><span><a href=\"CodeSystem-temporarycodes.html#temporarycodes-completed\">Temporary Codes</a> completed: Done, performed or completed</span></span></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_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=\"Item\" class=\"hierarchy\"/> nme5.6</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If Preventitive Action was implemented or is pending, provide a summary:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">[answer]</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\"/> nme6</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Study Protocol and Informed Consent</td><td style=\"vertical-align: top; text-align : left; background-color: #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=\"Item\" class=\"hierarchy\"/> nme6.1a</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Are changes required to the Study Protocol as a result of this report?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span><span><a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-Y\">expandedYes-NoIndicator</a> Y: Yes</span></span></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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme6.3a</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Are changes required to the Informed Consent as a result of this report?</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span><span><a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-Y\">expandedYes-NoIndicator</a> Y: Yes</span></span></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-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme6.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Are notifications or re-consenting of participants required as a result of changes in Study Protocol or Informed Consent?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span><span><a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-Y\">expandedYes-NoIndicator</a> Y: Yes</span></span></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-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> nme6.6</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If yes, detail how the notification and/or re-consent will occur:</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">[answer]</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> nme11</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Optional Attachments</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=\"Item\" class=\"hierarchy\"/> nme11.1</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 file that is being attached (optional)</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\">[answer]</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_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=\"Item\" class=\"hierarchy\"/> nme11.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Attachment</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\"><span><span>No display for Attachment</span></span></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_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: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> ADMIN00</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #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_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=\"Item\" class=\"hierarchy\"/> ADMIN01</td><td style=\"vertical-align: top; text-align : left; background-color: white; 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: 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\">nme</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=\"Item\" class=\"hierarchy\"/> ADMIN02</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #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\">initiate-study-populate-exampleQR</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=\"Item\" class=\"hierarchy\"/> ADMIN03</td><td style=\"vertical-align: top; text-align : left; background-color: white; 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: 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\">ResearchStudyExample-sIRB</td></tr>\r\n<tr><td colspan=\"4\" class=\"hierarchy\"><br/><a href=\"http://hl7.org/fhir/R4/formats.html#table\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format</a></td></tr></table></div>" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/workflow-researchStudy"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "ResearchStudy/ResearchStudyExample-sIRB" ] ; fhir:display [ fhir:v "ResearchStudyExample-sIRB" ] ] ] ) ; # fhir:questionnaire [ fhir:v "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevent-questionnaire-populate"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevent-questionnaire-populate> ] ; # fhir:status [ fhir:v "completed"] ; # fhir:authored [ fhir:v "2022-02-28T01:16:19.909Z"^^xsd:dateTime] ; # fhir:item ( [ fhir:linkId [ fhir:v "nme1" ] ; fhir:text [ fhir:v "Research Study" ] ; ( fhir:item [ fhir:linkId [ fhir:v "nme1.1" ] ; fhir:text [ fhir:v "Study Title" ] ; ( fhir:answer [ fhir:value [ fhir:v "Study of Drug A for arthritis" ] ] ) ] [ fhir:linkId [ fhir:v "nme1.3" ] ; fhir:text [ fhir:v "IRB Protocol Number" ] ; ( fhir:answer [ fhir:value [ fhir:v "PRO098765" ] ] ) ] [ fhir:linkId [ fhir:v "nme1.4" ] ; fhir:text [ fhir:v "Status" ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"^^xsd:anyURI ] ; fhir:code [ fhir:v "nochange" ] ; fhir:display [ fhir:v "No change in research activities" ] ] ] ) ] ) ] [ fhir:linkId [ fhir:v "nme7" ] ; fhir:text [ fhir:v "Organization/Site" ] ; ( fhir:item [ fhir:linkId [ fhir:v "nme7.1" ] ; fhir:text [ fhir:v "Where Adverse Non-Medical Event Occurred" ] ; ( fhir:item [ fhir:linkId [ fhir:v "nme7.1.8" ] ; fhir:text [ fhir:v "Did the Adverse Non-Medical Event occur at the lead principal investigator site?" ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0532"^^xsd:anyURI ] ; fhir:code [ fhir:v "N" ] ; fhir:display [ fhir:v "No" ] ] ] ) ] [ fhir:linkId [ fhir:v "nme7.1.11" ] ; fhir:text [ fhir:v "Did the Adverse Non-Medical Event occur at one of the relying sites?" ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0532"^^xsd:anyURI ] ; fhir:code [ fhir:v "Y" ] ; fhir:display [ fhir:v "Yes" ] ] ] ) ] [ fhir:linkId [ fhir:v "ExternalDataFor_nme7.1.9" ] ; fhir:text [ fhir:v "External Data For linkId nme7.1.9" ] ; ( fhir:answer [ fhir:value [ fhir:v "Sample University Medical Center | | Jane Doe, MD | Sample City, NC" ] ] [ fhir:value [ fhir:v "Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA" ] ] [ fhir:value [ fhir:v "Central Campus Test University | | Maria Smith, PhD | Central, MI" ] ] ) ] [ fhir:linkId [ fhir:v "nme7.1.9" ] ; fhir:text [ fhir:v "If the Adverse Non-Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the relying institution and relying site principal investigator details below." ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:display [ fhir:v "Central Campus Test University | | Maria Smith, PhD | Central, MI" ] ] ] ) ] [ fhir:linkId [ fhir:v "nme7.1.1" ] ; fhir:text [ fhir:v "Name of organization/site where the Adverse Non-Medical Event occurred" ] ; ( fhir:answer [ fhir:value [ fhir:v "Central Campus Test University" ] ] ) ] [ fhir:linkId [ fhir:v "nme7.1.2" ] ; fhir:text [ fhir:v "City" ] ; ( fhir:answer [ fhir:value [ fhir:v "Central" ] ] ) ] [ fhir:linkId [ fhir:v "nme7.1.3" ] ; fhir:text [ fhir:v "State" ] ; ( fhir:answer [ fhir:value [ fhir:v "MI" ] ] ) ] [ fhir:linkId [ fhir:v "nme7.1.4" ] ; fhir:text [ fhir:v "Country" ] ; ( fhir:answer [ fhir:value [ fhir:v "United States" ] ] ) ] ) ] [ fhir:linkId [ fhir:v "nme7.2" ] ; fhir:text [ fhir:v "Responsibility for Adverse Non-Medical Event Reporting" ] ; ( fhir:item [ fhir:linkId [ fhir:v "nme7.2.8" ] ; fhir:text [ fhir:v "If the Adverse Non-Medical Event occurred at a relying site or at another organization (unrelated to the lead principal investigator organization/site or relying sites), will the lead principal investigator site be recording the Adverse Non-Medical Event?" ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0532"^^xsd:anyURI ] ; fhir:code [ fhir:v "Y" ] ; fhir:display [ fhir:v "Yes" ] ] ] ) ] [ fhir:linkId [ fhir:v "nme7.2.1" ] ; fhir:text [ fhir:v "Name of organization/site which is recording the Adverse Non-Medical Event" ] ; ( fhir:answer [ fhir:value [ fhir:v "Sample University Medical Center" ] ] ) ] [ fhir:linkId [ fhir:v "nme7.2.2" ] ; fhir:text [ fhir:v "City" ] ; ( fhir:answer [ fhir:value [ fhir:v "Sample City" ] ] ) ] [ fhir:linkId [ fhir:v "nme7.2.3" ] ; fhir:text [ fhir:v "State" ] ; ( fhir:answer [ fhir:value [ fhir:v "NC" ] ] ) ] [ fhir:linkId [ fhir:v "nme7.2.4" ] ; fhir:text [ fhir:v "Country" ] ; ( fhir:answer [ fhir:value [ fhir:v "United States" ] ] ) ] ) ] ) ] [ fhir:linkId [ fhir:v "nme8" ] ; fhir:text [ fhir:v "Site Principal Investigator for the site where Adverse Non-Medical Event occurred" ] ; ( fhir:item [ fhir:linkId [ fhir:v "nme8.1" ] ; fhir:text [ fhir:v "First Name" ] ; ( fhir:answer [ fhir:value [ fhir:v "Maria" ] ] ) ] [ fhir:linkId [ fhir:v "nme8.4" ] ; fhir:text [ fhir:v "Last Name" ] ; ( fhir:answer [ fhir:value [ fhir:v "Smith" ] ] ) ] [ fhir:linkId [ fhir:v "nme8.6" ] ; fhir:text [ fhir:v "Degree(s)" ] ; ( fhir:answer [ fhir:value [ fhir:v "PhD" ] ] ) ] [ fhir:linkId [ fhir:v "nme8.2" ] ; fhir:text [ fhir:v "Phone" ] ; ( fhir:answer [ fhir:value [ fhir:v "8901231234" ] ] ) ] [ fhir:linkId [ fhir:v "nme8.3" ] ; fhir:text [ fhir:v "Email" ] ; ( fhir:answer [ fhir:value [ fhir:v "maria.smith@CCTU.med.edu" ] ] ) ] ) ] [ fhir:linkId [ fhir:v "nme3" ] ; fhir:text [ fhir:v "Report" ] ; ( fhir:item [ fhir:linkId [ fhir:v "nme3.1" ] ; fhir:text [ fhir:v "Report Date" ] ; ( fhir:answer [ fhir:value [ fhir:v "2022-02-27"^^xsd:date ] ] ) ] [ fhir:linkId [ fhir:v "nme3.2" ] ; fhir:text [ fhir:v "Report Status" ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"^^xsd:anyURI ] ; fhir:code [ fhir:v "init" ] ; fhir:display [ fhir:v "Initial" ] ] ] ) ] [ fhir:linkId [ fhir:v "nme3.3" ] ; fhir:text [ fhir:v "Select at least one of the following criteria:" ] ; ( fhir:item [ fhir:linkId [ fhir:v "nme3.3.4" ] ; fhir:text [ fhir:v "New information resulted in unexpected change in risks of the research" ] ; ( fhir:answer [ fhir:value [ fhir:v "true"^^xsd:boolean ] ] ) ] [ fhir:linkId [ fhir:v "nme3.3.5" ] ; fhir:text [ fhir:v "New or increased risk" ] ; ( fhir:item [ fhir:linkId [ fhir:v "nme3.3.5.1" ] ; fhir:text [ fhir:v "Date:" ] ; ( fhir:answer [ fhir:value [ fhir:v "2022-02-27"^^xsd:date ] ] ) ] [ fhir:linkId [ fhir:v "nme3.3.5.2" ] ; fhir:text [ fhir:v "Date discovered:" ] ; ( fhir:answer [ fhir:value [ fhir:v "2022-02-26"^^xsd:date ] ] ) ] [ fhir:linkId [ fhir:v "nme3.3.5.3" ] ; fhir:text [ fhir:v "Description:" ] ; ( fhir:answer [ fhir:value [ fhir:v "[answer]" ] ] ) ] ) ] [ fhir:linkId [ fhir:v "nme3.3.6" ] ; fhir:text [ fhir:v "Unanticipated Problem Involving Risk to Participants or Others" ] ; ( fhir:answer [ fhir:value [ fhir:v "true"^^xsd:boolean ] ] ) ] [ fhir:linkId [ fhir:v "nme3.3.7" ] ; fhir:text [ fhir:v "Unanticipated Problem" ] ; ( fhir:item [ fhir:linkId [ fhir:v "nme3.3.7.1" ] ; fhir:text [ fhir:v "Event date:" ] ; ( fhir:answer [ fhir:value [ fhir:v "2022-02-26"^^xsd:date ] ] ) ] [ fhir:linkId [ fhir:v "nme3.3.7.2" ] ; fhir:text [ fhir:v "Date event became aware to study team:" ] ; ( fhir:answer [ fhir:value [ fhir:v "2022-02-27"^^xsd:date ] ] ) ] [ fhir:linkId [ fhir:v "nme3.3.7.3" ] ; fhir:text [ fhir:v "Event Summary:" ] ; ( fhir:answer [ fhir:value [ fhir:v "[answer]" ] ] ) ] [ fhir:linkId [ fhir:v "nme3.3.7.4" ] ; fhir:text [ fhir:v "Was this event Unexpected?" ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0532"^^xsd:anyURI ] ; fhir:code [ fhir:v "Y" ] ; fhir:display [ fhir:v "Yes" ] ] ] ) ] [ fhir:linkId [ fhir:v "nme3.3.7.5" ] ; fhir:text [ fhir:v "If yes, please explain:" ] ; ( fhir:answer [ fhir:value [ fhir:v "[answer]" ] ] ) ] [ fhir:linkId [ fhir:v "nme3.3.7.6" ] ; fhir:text [ fhir:v "Was this event Related or Possibly Related to participation in the research?" ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0532"^^xsd:anyURI ] ; fhir:code [ fhir:v "Y" ] ; fhir:display [ fhir:v "Yes" ] ] ] ) ] [ fhir:linkId [ fhir:v "nme3.3.7.7" ] ; fhir:text [ fhir:v "If yes, please explain:" ] ; ( fhir:answer [ fhir:value [ fhir:v "[answer]" ] ] ) ] [ fhir:linkId [ fhir:v "nme3.3.7.8" ] ; fhir:text [ fhir:v "Does this event suggest that the research places participant(s) or others at a greater Risk of harm than was previously known?" ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0532"^^xsd:anyURI ] ; fhir:code [ fhir:v "Y" ] ; fhir:display [ fhir:v "Yes" ] ] ] ) ] [ fhir:linkId [ fhir:v "nme3.3.7.9" ] ; fhir:text [ fhir:v "If yes, please explain:" ] ; ( fhir:answer [ fhir:value [ fhir:v "[answer]" ] ] ) ] ) ] [ fhir:linkId [ fhir:v "nme3.3.10" ] ; fhir:text [ fhir:v "A breach of Confidentiality" ] ; ( fhir:answer [ fhir:value [ fhir:v "false"^^xsd:boolean ] ] ) ] [ fhir:linkId [ fhir:v "nme3.3.14" ] ; fhir:text [ fhir:v "Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team" ] ; ( fhir:answer [ fhir:value [ fhir:v "true"^^xsd:boolean ] ] ) ] [ fhir:linkId [ fhir:v "nme3.3.15" ] ; fhir:text [ fhir:v "Participant Complaint" ] ; ( fhir:item [ fhir:linkId [ fhir:v "nme3.3.15.1" ] ; fhir:text [ fhir:v "Complaint Date:" ] ; ( fhir:answer [ fhir:value [ fhir:v "2022-02-27"^^xsd:date ] ] ) ] [ fhir:linkId [ fhir:v "nme3.3.15.2" ] ; fhir:text [ fhir:v "Date received:" ] ; ( fhir:answer [ fhir:value [ fhir:v "2022-02-27"^^xsd:date ] ] ) ] [ fhir:linkId [ fhir:v "nme3.3.15.3" ] ; fhir:text [ fhir:v "Description:" ] ; ( fhir:answer [ fhir:value [ fhir:v "[answer]" ] ] ) ] ) ] ) ] ) ] [ fhir:linkId [ fhir:v "nme4" ] ; fhir:text [ fhir:v "Reporting" ] ; ( fhir:item [ fhir:linkId [ fhir:v "nme4.1" ] ; fhir:text [ fhir:v "Was the Sponsor notified?" ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0532"^^xsd:anyURI ] ; fhir:code [ fhir:v "Y" ] ; fhir:display [ fhir:v "Yes" ] ] ] ) ] [ fhir:linkId [ fhir:v "nme4.2" ] ; fhir:text [ fhir:v "Notification date:" ] ; ( fhir:answer [ fhir:value [ fhir:v "2022-02-27"^^xsd:date ] ] ) ] [ fhir:linkId [ fhir:v "nme4.3" ] ; fhir:text [ fhir:v "Was the IRB notified?" ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0532"^^xsd:anyURI ] ; fhir:code [ fhir:v "Y" ] ; fhir:display [ fhir:v "Yes" ] ] ] ) ] [ fhir:linkId [ fhir:v "nme4.4" ] ; fhir:text [ fhir:v "Notification date:" ] ; ( fhir:answer [ fhir:value [ fhir:v "2022-02-27"^^xsd:date ] ] ) ] [ fhir:linkId [ fhir:v "nme4.5" ] ; fhir:text [ fhir:v "Were any Other Parties notified?" ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0532"^^xsd:anyURI ] ; fhir:code [ fhir:v "Y" ] ; fhir:display [ fhir:v "Yes" ] ] ] ) ] [ fhir:linkId [ fhir:v "nme4.6" ] ; fhir:text [ fhir:v "List other notified parties" ] ; ( fhir:answer [ fhir:value [ fhir:v "[answer]" ] ] ) ] ) ] [ fhir:linkId [ fhir:v "nme5" ] ; fhir:text [ fhir:v "Corrective and Preventative Action Plan" ] ; ( fhir:item [ fhir:linkId [ fhir:v "nme5.1" ] ; fhir:text [ fhir:v "Was a Root Cause analysis performed?" ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"^^xsd:anyURI ] ; fhir:code [ fhir:v "pending" ] ; fhir:display [ fhir:v "Pending - Currently under development" ] ] ] ) ] [ fhir:linkId [ fhir:v "nme5.2b" ] ; fhir:text [ fhir:v "If pending, describe status and interim findings, if any:" ] ; ( fhir:answer [ fhir:value [ fhir:v "[answer]" ] ] ) ] [ fhir:linkId [ fhir:v "nme5.3" ] ; fhir:text [ fhir:v "Was Corrective Action implemented?" ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"^^xsd:anyURI ] ; fhir:code [ fhir:v "pending" ] ; fhir:display [ fhir:v "Pending - Currently under development" ] ] ] ) ] [ fhir:linkId [ fhir:v "nme5.4" ] ; fhir:text [ fhir:v "If Corrective Action was implemented or is pending, provide a summary:" ] ; ( fhir:answer [ fhir:value [ fhir:v "[answer]" ] ] ) ] [ fhir:linkId [ fhir:v "nme5.5" ] ; fhir:text [ fhir:v "Was Preventitive Action implemented?" ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"^^xsd:anyURI ] ; fhir:code [ fhir:v "completed" ] ; fhir:display [ fhir:v "Done, performed or completed" ] ] ] ) ] [ fhir:linkId [ fhir:v "nme5.6" ] ; fhir:text [ fhir:v "If Preventitive Action was implemented or is pending, provide a summary:" ] ; ( fhir:answer [ fhir:value [ fhir:v "[answer]" ] ] ) ] ) ] [ fhir:linkId [ fhir:v "nme6" ] ; fhir:text [ fhir:v "Study Protocol and Informed Consent" ] ; ( fhir:item [ fhir:linkId [ fhir:v "nme6.1a" ] ; fhir:text [ fhir:v "Are changes required to the Study Protocol as a result of this report?" ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0532"^^xsd:anyURI ] ; fhir:code [ fhir:v "Y" ] ; fhir:display [ fhir:v "Yes" ] ] ] ) ] [ fhir:linkId [ fhir:v "nme6.3a" ] ; fhir:text [ fhir:v "Are changes required to the Informed Consent as a result of this report?" ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0532"^^xsd:anyURI ] ; fhir:code [ fhir:v "Y" ] ; fhir:display [ fhir:v "Yes" ] ] ] ) ] [ fhir:linkId [ fhir:v "nme6.5" ] ; fhir:text [ fhir:v "Are notifications or re-consenting of participants required as a result of changes in Study Protocol or Informed Consent?" ] ; ( fhir:answer [ fhir:value [ a fhir:Coding ; fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0532"^^xsd:anyURI ] ; fhir:code [ fhir:v "Y" ] ; fhir:display [ fhir:v "Yes" ] ] ] ) ] [ fhir:linkId [ fhir:v "nme6.6" ] ; fhir:text [ fhir:v "If yes, detail how the notification and/or re-consent will occur:" ] ; ( fhir:answer [ fhir:value [ fhir:v "[answer]" ] ] ) ] ) ] [ fhir:linkId [ fhir:v "nme11" ] ; fhir:text [ fhir:v "Optional Attachments" ] ; ( fhir:item [ fhir:linkId [ fhir:v "nme11.1" ] ; fhir:text [ fhir:v "Describe the file that is being attached (optional)" ] ; ( fhir:answer [ fhir:value [ fhir:v "[answer]" ] ] ) ] [ fhir:linkId [ fhir:v "nme11.2" ] ; fhir:text [ fhir:v "Attachment" ] ; ( fhir:answer [ fhir:value [ a fhir:Attachment 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] ; fhir:title [ fhir:v "Example attachment.docx" ] ; fhir:creation [ fhir:v "2022-02-27T22:24:16.963Z"^^xsd:dateTime ] ] ] ) ] ) ] [ fhir:linkId [ fhir:v "ADMIN00" ] ; fhir:text [ fhir:v "Administrative Use Only" ] ; ( fhir:item [ fhir:linkId [ fhir:v "ADMIN01" ] ; fhir:text [ fhir:v "Link ID prefix" ] ; ( fhir:answer [ fhir:value [ fhir:v "nme" ] ] ) ] [ fhir:linkId [ fhir:v "ADMIN02" ] ; fhir:text [ fhir:v "Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any" ] ; ( fhir:answer [ fhir:value [ fhir:v "initiate-study-populate-exampleQR" ] ] ) ] [ fhir:linkId [ fhir:v "ADMIN03" ] ; fhir:text [ fhir:v "ID of the Research Study FHIR Resource associated with the study Questionnaire Responses" ] ; ( fhir:answer [ fhir:value [ fhir:v "ResearchStudyExample-sIRB" ] ] ) ] ) ] ) . #
IG © 2020+ HL7 International - BR&R Work Group. Package hl7.fhir.us.sirb#1.0.0 based on FHIR 4.0.1. Generated 2023-04-20
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