Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use

Single Institutional Review Board (sIRB) Implementation Guide, published by HL7 International - BR&R Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/fhir-sirb/ and changes regularly. See the Directory of published versions

## : Example Adverse Non-Medical Event Questionnaire Response - TTL Representation

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

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

     a fhir: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, \" 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, \" 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 ;
    fhir:contentType [ fhir:v "application/vnd.openxmlformats-officedocument.wordprocessingml.document" ] ;
    fhir:data [ fhir:v " "^^xsd:base64Binary ] ;
    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" ]       ] )     ] )
      ] ) . #