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 Medical Event Questionnaire Response - JSON Representation

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    {
      "resourceType" : "QuestionnaireResponse",
      "id" : "medical-ae-populate-exampleQR",
      "meta" : {
        "versionId" : "1",
        "lastUpdated" : "2022-03-12T01:53:26.773+00:00"
      },
      "text" : {
        "status" : "generated",
        "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\"/> medical-ae-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\"/> mae1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Research Study</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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\"/> mae1.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Study Title</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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\"/> mae1.2</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_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\"/> mae1.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Study Type</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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-INT\">Temporary Codes</a> INT: Interventional</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\"/> mae1.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Does this protocol require an FDA exemption?</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_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\"/> mae1.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is an IND or IDE being used in this study?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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_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\"/> mae4</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\"/> mae4.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Where Adverse 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\"/> mae4.1.7</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 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\"/> ExternalDataFor_mae4.1.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">External Data For linkId mae4.1.1</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\"/> mae4.1.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If the Adverse Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the the relying institution and relying site principal investigator details below.</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>[not stated] : Test Example University  |     |  Xi-Yang Lee, Jr., MD, PhD  |  Example, MA</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_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\"/> mae4.1.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Name of organization/site where the event occurred</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Test Example University</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> mae4.7</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Site Principal Investigator</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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\"/> mae4.7.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">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\">Xi-Yang</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\"/> mae4.7.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">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\">Lee</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\"/> mae4.7.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Suffix</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\">Jr.</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\"/> mae4.7.6</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Degree(s)</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\">MD, PhD</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\"/> mae4.7.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Phone</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\">6781233456</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> mae4.7.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Email</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\">XiYangLee@teu.med.edu</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\"/> mae4.9</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Responsibility for Adverse Medical Event Reporting</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\"/> mae4.9.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If the Adverse Medical Event occurred at a relying site, will the lead principal investigator site be 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\"><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_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\"/> mae4.9.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Name of organization/site which is recording the Adverse 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\">Sample University Medical Center</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\"/> mae3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Primary Contact</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\"/> mae3.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">First Name</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Jane</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\"/> mae3.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Last Name</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Doe</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\"/> mae3.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Phone</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">567-123-1234</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\"/> mae3.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Email</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">drjanedoe@sampleuniversity.edu</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\"/> mae5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Participant Information</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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\"/> mae5.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Patient ID</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">12345</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\"/> mae5.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Age</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\">58</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\"/> mae5.3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Birth Sex</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-v2-0001.html#v2-0001-M\">administrativeSex</a> M: Male</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\"/> mae5.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Weight</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>245 [lb]</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\"/> mae5.5</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Height</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>67 [in]</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\"/> mae5.6</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Ethnicity</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-v3-Ethnicity.html#v3-Ethnicity-2186-5\">Ethnicity</a> 2186-5: Not Hispanic or Latino</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\"/> mae5.7</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Race</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-v3-Race.html#v3-Race-2106-3\">Race</a> 2106-3: White</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\"/> mae5.8</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Which Arm/Cohort/treatment group was the participant assigned to (if known)?</td><td style=\"vertical-align: top; text-align : left; background-color: 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\">unknown</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\"/> mae5.9</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Participant dosed or received study agent</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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-NI\">expandedYes-NoIndicator</a> NI: No Information</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\"/> mae5.11</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Were there any Protocol Deviations/Violations/Exceptions for this participant?</td><td style=\"vertical-align: top; text-align : left; background-color: 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-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: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> mae6</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Adverse Medical Event Information</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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\"/> mae6.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Submission Type</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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-INITIAL\">Temporary Codes</a> INITIAL: Initial</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\"/> mae6.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Start Date</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\">2021-11-05</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\"/> mae6.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Reported Date</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">2021-11-06</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\"/> mae6.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Recorded 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\">2021-11-06</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\"/> mae6.10</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is the Adverse Medical Event Serious?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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-adverse-event-seriousness.html#adverse-event-seriousness-serious\">AdverseEventSeriousness</a> serious: Serious</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\"/> mae6.9</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Severity</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-adverse-event-severity.html#adverse-event-severity-mild\">AdverseEventSeverity</a> mild: Mild</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\"/> mae6.40</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Narrative of the Adverse Event:</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Blood clot developed in right leg after several days of inactivity.  Participant experienced swelling and pain.</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\"/> mae6.5</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Medical Description of Adverse Event</td><td style=\"vertical-align: top; text-align : left; background-color: #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\">Deep Vein Thrombosis</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\"/> mae6.6</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is the Adverse Medical event still ongoing?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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-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: #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\"/> mae6.7</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Stop Date</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\">2021-11-05</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\"/> mae6.8</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Was the event expected?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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-v2-0239.html#v2-0239-N\">eventExpected</a> N: No</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_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> mae6.11</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Seriousness</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> mae6.11.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Seriousness</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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-ResultsInHospitalization\">Temporary Codes</a> ResultsInHospitalization: Requires or prolongs inpatient hospitalization</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\"/> mae6.12</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">What is the date Adverse Medical Event became serious?</td><td style=\"vertical-align: top; text-align : left; background-color: #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\">2021-11-05</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\"/> mae6.13</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Outcome of Adverse Medical Event</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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-RCVRED\">Temporary Codes</a> RCVRED: recovered/resolved</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\"/> mae6.15</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Relationship of Adverse Medical Event to Study Intervention</td><td style=\"vertical-align: top; text-align : left; background-color: #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-adverse-event-causality-assess.html#adverse-event-causality-assess-possible\">AdverseEventCausalityAssessment</a> possible: Possible</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\"/> mae6.16</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Rationale for relationship with study intervention</td><td style=\"vertical-align: top; text-align : left; background-color: 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\">Patient was inactive for several days which might have been the cause.</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> mae6.23</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Action Taken</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> mae6.23.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Action Taken Regarding Study Intervention</td><td style=\"vertical-align: top; text-align : left; background-color: 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-v2-0251.html#v2-0251-WT\">actionTakenInResponseToTheEvent</a> WT: Product withdrawn temporarily</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\"/> mae6.24</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate?</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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\"/> mae6.25</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If study intervention was restarted (rechallenge) did AE recur?</td><td style=\"vertical-align: top; text-align : left; background-color: 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-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: #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\"/> mae6.50</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">SAE Concomitant Medications, Treatments/Procedures and Tests</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\"/> mae6.50.26</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Did the participant receive any relevant concomitant medications in response to the SAE?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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_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\"/> mae6.50.28</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">SAE Concomitant Medications</td><td style=\"vertical-align: top; text-align : left; background-color: #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\"/> mae6.50.28.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Medication Name</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">warfarin</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\"/> mae6.50.28.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indication</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\">anticoagulant</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\"/> mae6.50.28.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Start Date</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">2021-11-05</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\"/> mae6.50.28.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Stop Date</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\">2022-02-04</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\"/> mae6.50.28.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Ongoing</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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-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: #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\"/> mae6.50.29</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Did the participant receive any treatments/procedures in response to the SAE?</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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_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\"/> mae6.50.37</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><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_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\"/> mae6.50.38</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">SAE Laboratory or Diagnostic Tests</td><td style=\"vertical-align: top; text-align : left; background-color: #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\"/> mae6.50.38.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Lab/Diagnostic Test</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">ultrasound</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\"/> mae6.50.38.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Date</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">2021-11-05</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_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\"/> mae6.50.38.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Result</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">positive</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> mae6.50.38.6</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Comments</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">blood clot noted</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\"/> mae11</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\"/> mae11.1</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\">Treatment instructions received from sponsor regarding this AE.</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\"/> mae11.2</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\">mae</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>"
      },
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/workflow-researchStudy",
          "valueReference" : {
            "reference" : "ResearchStudy/ResearchStudyExample-sIRB",
            "display" : "ResearchStudyExample-sIRB"
          }
        }
      ],
      "questionnaire" : "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire-populate",
      "status" : "completed",
      "authored" : "2022-03-12T01:53:25.336Z",
      "item" : [
        {
          "linkId" : "mae1",
          "text" : "Research Study",
          "item" : [
            {
              "linkId" : "mae1.1",
              "text" : "Study Title",
              "answer" : [
                {
                  "valueString" : "Study of Drug A for arthritis"
                }
              ]
            },
            {
              "linkId" : "mae1.2",
              "text" : "IRB Protocol Number",
              "answer" : [
                {
                  "valueString" : "PRO098765"
                }
              ]
            },
            {
              "linkId" : "mae1.3",
              "text" : "Study Type",
              "answer" : [
                {
                  "valueCoding" : {
                    "system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code" : "INT",
                    "display" : "Interventional"
                  }
                }
              ]
            },
            {
              "linkId" : "mae1.4",
              "text" : "Does this protocol require an FDA exemption?",
              "answer" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "Y",
                    "display" : "Yes"
                  }
                }
              ]
            },
            {
              "linkId" : "mae1.5",
              "text" : "Is an IND or IDE being used in this study?",
              "answer" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "Y",
                    "display" : "Yes"
                  }
                }
              ]
            }
          ]
        },
        {
          "linkId" : "mae4",
          "text" : "Organization/Site",
          "item" : [
            {
              "linkId" : "mae4.1",
              "text" : "Where Adverse Medical Event Occurred",
              "item" : [
                {
                  "linkId" : "mae4.1.7",
                  "text" : "Did the Adverse Medical Event occur at the lead principal investigator site?",
                  "answer" : [
                    {
                      "valueCoding" : {
                        "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                        "code" : "N",
                        "display" : "No"
                      }
                    }
                  ]
                },
                {
                  "linkId" : "ExternalDataFor_mae4.1.1",
                  "text" : "External Data For linkId mae4.1.1",
                  "answer" : [
                    {
                      "valueString" : "Sample University Medical Center  |     |  Jane Doe, MD  |  Sample City, NC"
                    },
                    {
                      "valueString" : "Test Example University  |     |  Xi-Yang Lee, Jr., MD, PhD  |  Example, MA"
                    },
                    {
                      "valueString" : "Central Campus Test University  |     |  Maria Smith, PhD  |  Central, MI"
                    }
                  ]
                },
                {
                  "linkId" : "mae4.1.1",
                  "text" : "If the Adverse Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the the relying institution and relying site principal investigator details below.",
                  "answer" : [
                    {
                      "valueCoding" : {
                        "display" : "Test Example University  |     |  Xi-Yang Lee, Jr., MD, PhD  |  Example, MA"
                      }
                    }
                  ]
                },
                {
                  "linkId" : "mae4.1.2",
                  "text" : "Name of organization/site where the event occurred",
                  "answer" : [
                    {
                      "valueString" : "Test Example University"
                    }
                  ]
                }
              ]
            },
            {
              "linkId" : "mae4.7",
              "text" : "Site Principal Investigator",
              "item" : [
                {
                  "linkId" : "mae4.7.1",
                  "text" : "First Name",
                  "answer" : [
                    {
                      "valueString" : "Xi-Yang"
                    }
                  ]
                },
                {
                  "linkId" : "mae4.7.2",
                  "text" : "Last Name",
                  "answer" : [
                    {
                      "valueString" : "Lee"
                    }
                  ]
                },
                {
                  "linkId" : "mae4.7.5",
                  "text" : "Suffix",
                  "answer" : [
                    {
                      "valueString" : "Jr."
                    }
                  ]
                },
                {
                  "linkId" : "mae4.7.6",
                  "text" : "Degree(s)",
                  "answer" : [
                    {
                      "valueString" : "MD, PhD"
                    }
                  ]
                },
                {
                  "linkId" : "mae4.7.3",
                  "text" : "Phone",
                  "answer" : [
                    {
                      "valueString" : "6781233456"
                    }
                  ]
                },
                {
                  "linkId" : "mae4.7.4",
                  "text" : "Email",
                  "answer" : [
                    {
                      "valueString" : "XiYangLee@teu.med.edu"
                    }
                  ]
                }
              ]
            },
            {
              "linkId" : "mae4.9",
              "text" : "Responsibility for Adverse Medical Event Reporting",
              "item" : [
                {
                  "linkId" : "mae4.9.1",
                  "text" : "If the Adverse Medical Event occurred at a relying site, will the lead principal investigator site be recording the Adverse Non-Medical Event?",
                  "answer" : [
                    {
                      "valueCoding" : {
                        "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                        "code" : "Y",
                        "display" : "Yes"
                      }
                    }
                  ]
                },
                {
                  "linkId" : "mae4.9.2",
                  "text" : "Name of organization/site which is recording the Adverse Medical event",
                  "answer" : [
                    {
                      "valueString" : "Sample University Medical Center"
                    }
                  ]
                }
              ]
            }
          ]
        },
        {
          "linkId" : "mae3",
          "text" : "Primary Contact",
          "item" : [
            {
              "linkId" : "mae3.1",
              "text" : "First Name",
              "answer" : [
                {
                  "valueString" : "Jane"
                }
              ]
            },
            {
              "linkId" : "mae3.2",
              "text" : "Last Name",
              "answer" : [
                {
                  "valueString" : "Doe"
                }
              ]
            },
            {
              "linkId" : "mae3.3",
              "text" : "Phone",
              "answer" : [
                {
                  "valueString" : "567-123-1234"
                }
              ]
            },
            {
              "linkId" : "mae3.4",
              "text" : "Email",
              "answer" : [
                {
                  "valueString" : "drjanedoe@sampleuniversity.edu"
                }
              ]
            }
          ]
        },
        {
          "linkId" : "mae5",
          "text" : "Participant Information",
          "item" : [
            {
              "linkId" : "mae5.1",
              "text" : "Patient ID",
              "answer" : [
                {
                  "valueString" : "12345"
                }
              ]
            },
            {
              "linkId" : "mae5.2",
              "text" : "Age",
              "answer" : [
                {
                  "valueString" : "58"
                }
              ]
            },
            {
              "linkId" : "mae5.3",
              "text" : "Birth Sex",
              "answer" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0001",
                    "code" : "M",
                    "display" : "Male"
                  }
                }
              ]
            },
            {
              "linkId" : "mae5.4",
              "text" : "Weight",
              "answer" : [
                {
                  "valueQuantity" : {
                    "value" : 245,
                    "unit" : "[lb]"
                  }
                }
              ]
            },
            {
              "linkId" : "mae5.5",
              "text" : "Height",
              "answer" : [
                {
                  "valueQuantity" : {
                    "value" : 67,
                    "unit" : "[in]"
                  }
                }
              ]
            },
            {
              "linkId" : "mae5.6",
              "text" : "Ethnicity",
              "answer" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v3-Ethnicity",
                    "code" : "2186-5",
                    "display" : "Not Hispanic or Latino"
                  }
                }
              ]
            },
            {
              "linkId" : "mae5.7",
              "text" : "Race",
              "answer" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v3-Race",
                    "code" : "2106-3",
                    "display" : "White"
                  }
                }
              ]
            },
            {
              "linkId" : "mae5.8",
              "text" : "Which Arm/Cohort/treatment group was the participant assigned to (if known)?",
              "answer" : [
                {
                  "valueString" : "unknown"
                }
              ]
            },
            {
              "linkId" : "mae5.9",
              "text" : "Participant dosed or received study agent",
              "answer" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "NI",
                    "display" : "No Information"
                  }
                }
              ]
            },
            {
              "linkId" : "mae5.11",
              "text" : "Were there any Protocol Deviations/Violations/Exceptions for this participant?",
              "answer" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "N",
                    "display" : "No"
                  }
                }
              ]
            }
          ]
        },
        {
          "linkId" : "mae6",
          "text" : "Adverse Medical Event Information",
          "item" : [
            {
              "linkId" : "mae6.1",
              "text" : "Submission Type",
              "answer" : [
                {
                  "valueCoding" : {
                    "system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code" : "INITIAL",
                    "display" : "Initial"
                  }
                }
              ]
            },
            {
              "linkId" : "mae6.2",
              "text" : "Start Date",
              "answer" : [
                {
                  "valueDate" : "2021-11-05"
                }
              ]
            },
            {
              "linkId" : "mae6.3",
              "text" : "Reported Date",
              "answer" : [
                {
                  "valueDate" : "2021-11-06"
                }
              ]
            },
            {
              "linkId" : "mae6.4",
              "text" : "Recorded Date",
              "answer" : [
                {
                  "valueDate" : "2021-11-06"
                }
              ]
            },
            {
              "linkId" : "mae6.10",
              "text" : "Is the Adverse Medical Event Serious?",
              "answer" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
                    "code" : "serious",
                    "display" : "Serious"
                  }
                }
              ]
            },
            {
              "linkId" : "mae6.9",
              "text" : "Severity",
              "answer" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
                    "code" : "mild",
                    "display" : "Mild"
                  }
                }
              ]
            },
            {
              "linkId" : "mae6.40",
              "text" : "Narrative of the Adverse Event:",
              "answer" : [
                {
                  "valueString" : "Blood clot developed in right leg after several days of inactivity.  Participant experienced swelling and pain."
                }
              ]
            },
            {
              "linkId" : "mae6.5",
              "text" : "Medical Description of Adverse Event",
              "answer" : [
                {
                  "valueString" : "Deep Vein Thrombosis"
                }
              ]
            },
            {
              "linkId" : "mae6.6",
              "text" : "Is the Adverse Medical event still ongoing?",
              "answer" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "N",
                    "display" : "No"
                  }
                }
              ]
            },
            {
              "linkId" : "mae6.7",
              "text" : "Stop Date",
              "answer" : [
                {
                  "valueDate" : "2021-11-05"
                }
              ]
            },
            {
              "linkId" : "mae6.8",
              "text" : "Was the event expected?",
              "answer" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0239",
                    "code" : "N",
                    "display" : "No"
                  }
                }
              ]
            },
            {
              "linkId" : "mae6.11",
              "text" : "Seriousness",
              "item" : [
                {
                  "linkId" : "mae6.11.1",
                  "text" : "Seriousness",
                  "answer" : [
                    {
                      "valueCoding" : {
                        "system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                        "code" : "ResultsInHospitalization",
                        "display" : "Requires or prolongs inpatient hospitalization"
                      }
                    }
                  ]
                }
              ]
            },
            {
              "linkId" : "mae6.12",
              "text" : "What is the date Adverse Medical Event became serious?",
              "answer" : [
                {
                  "valueDate" : "2021-11-05"
                }
              ]
            },
            {
              "linkId" : "mae6.13",
              "text" : "Outcome of Adverse Medical Event",
              "answer" : [
                {
                  "valueCoding" : {
                    "system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code" : "RCVRED",
                    "display" : "recovered/resolved"
                  }
                }
              ]
            },
            {
              "linkId" : "mae6.15",
              "text" : "Relationship of Adverse Medical Event to Study Intervention",
              "answer" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
                    "code" : "possible",
                    "display" : "Possible"
                  }
                }
              ]
            },
            {
              "linkId" : "mae6.16",
              "text" : "Rationale for relationship with study intervention",
              "answer" : [
                {
                  "valueString" : "Patient was inactive for several days which might have been the cause."
                }
              ]
            },
            {
              "linkId" : "mae6.23",
              "text" : "Action Taken",
              "item" : [
                {
                  "linkId" : "mae6.23.1",
                  "text" : "Action Taken Regarding Study Intervention",
                  "answer" : [
                    {
                      "valueCoding" : {
                        "system" : "http://terminology.hl7.org/CodeSystem/v2-0251",
                        "code" : "WT",
                        "display" : "Product withdrawn temporarily"
                      }
                    }
                  ]
                }
              ]
            },
            {
              "linkId" : "mae6.24",
              "text" : "If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate?",
              "answer" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "Y",
                    "display" : "Yes"
                  }
                }
              ]
            },
            {
              "linkId" : "mae6.25",
              "text" : "If study intervention was restarted (rechallenge) did AE recur?",
              "answer" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "N",
                    "display" : "No"
                  }
                }
              ]
            },
            {
              "linkId" : "mae6.50",
              "text" : "SAE Concomitant Medications, Treatments/Procedures and Tests",
              "item" : [
                {
                  "linkId" : "mae6.50.26",
                  "text" : "Did the participant receive any relevant concomitant medications in response to the SAE?",
                  "answer" : [
                    {
                      "valueCoding" : {
                        "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                        "code" : "Y",
                        "display" : "Yes"
                      }
                    }
                  ]
                },
                {
                  "linkId" : "mae6.50.28",
                  "text" : "SAE Concomitant Medications",
                  "item" : [
                    {
                      "linkId" : "mae6.50.28.1",
                      "text" : "Medication Name",
                      "answer" : [
                        {
                          "valueString" : "warfarin"
                        }
                      ]
                    },
                    {
                      "linkId" : "mae6.50.28.2",
                      "text" : "Indication",
                      "answer" : [
                        {
                          "valueString" : "anticoagulant"
                        }
                      ]
                    },
                    {
                      "linkId" : "mae6.50.28.3",
                      "text" : "Start Date",
                      "answer" : [
                        {
                          "valueDate" : "2021-11-05"
                        }
                      ]
                    },
                    {
                      "linkId" : "mae6.50.28.4",
                      "text" : "Stop Date",
                      "answer" : [
                        {
                          "valueDate" : "2022-02-04"
                        }
                      ]
                    },
                    {
                      "linkId" : "mae6.50.28.5",
                      "text" : "Ongoing",
                      "answer" : [
                        {
                          "valueCoding" : {
                            "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                            "code" : "N",
                            "display" : "No"
                          }
                        }
                      ]
                    }
                  ]
                },
                {
                  "linkId" : "mae6.50.29",
                  "text" : "Did the participant receive any treatments/procedures in response to the SAE?",
                  "answer" : [
                    {
                      "valueCoding" : {
                        "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                        "code" : "N",
                        "display" : "No"
                      }
                    }
                  ]
                },
                {
                  "linkId" : "mae6.50.37",
                  "text" : "Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?",
                  "answer" : [
                    {
                      "valueCoding" : {
                        "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                        "code" : "Y",
                        "display" : "Yes"
                      }
                    }
                  ]
                },
                {
                  "linkId" : "mae6.50.38",
                  "text" : "SAE Laboratory or Diagnostic Tests",
                  "item" : [
                    {
                      "linkId" : "mae6.50.38.1",
                      "text" : "Lab/Diagnostic Test",
                      "answer" : [
                        {
                          "valueString" : "ultrasound"
                        }
                      ]
                    },
                    {
                      "linkId" : "mae6.50.38.2",
                      "text" : "Date",
                      "answer" : [
                        {
                          "valueDate" : "2021-11-05"
                        }
                      ]
                    },
                    {
                      "linkId" : "mae6.50.38.3",
                      "text" : "Result",
                      "answer" : [
                        {
                          "valueString" : "positive"
                        }
                      ]
                    },
                    {
                      "linkId" : "mae6.50.38.6",
                      "text" : "Comments",
                      "answer" : [
                        {
                          "valueString" : "blood clot noted"
                        }
                      ]
                    }
                  ]
                }
              ]
            }
          ]
        },
        {
          "linkId" : "mae11",
          "text" : "Optional Attachments",
          "item" : [
            {
              "linkId" : "mae11.1",
              "text" : "Describe the file that is being attached (optional)",
              "answer" : [
                {
                  "valueString" : "Treatment instructions received from sponsor regarding this AE."
                }
              ]
            },
            {
              "linkId" : "mae11.2",
              "text" : "Attachment",
              "answer" : [
                {
                  "valueAttachment" : {
                    "url" : "http://example.org/NationalGovernmentFunder/AE/NationalGovernmentFunderInstructions.pdf",
                    "title" : "NationalGovernmentFunderInstructions.pdf"
                  }
                }
              ]
            }
          ]
        },
        {
          "linkId" : "ADMIN00",
          "text" : "Administrative Use Only",
          "item" : [
            {
              "linkId" : "ADMIN01",
              "text" : "Link ID prefix",
              "answer" : [
                {
                  "valueString" : "mae"
                }
              ]
            },
            {
              "linkId" : "ADMIN02",
              "text" : "Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any",
              "answer" : [
                {
                  "valueString" : "initiate-study-populate-exampleQR"
                }
              ]
            },
            {
              "linkId" : "ADMIN03",
              "text" : "ID of the Research Study FHIR Resource associated with the study Questionnaire Responses",
              "answer" : [
                {
                  "valueString" : "ResearchStudyExample-sIRB"
                }
              ]
            }
          ]
        }
      ]
    }