Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot
Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot
This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions 
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:QuestionnaireResponse;
fhir:nodeRole fhir:treeRoot;
fhir:Resource.id [ fhir:value "NME-QR"];
fhir:Resource.meta [
fhir:Meta.versionId [ fhir:value "3" ];
fhir:Meta.lastUpdated [ fhir:value "2021-07-27T02:23:03.257+00:00"^^xsd:dateTime ];
fhir:Meta.source [ fhir:value "#Eo51qLbujzofNeCw" ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>questionnaire</b>: <a href=\"https://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevents-questionnaire\">https://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevents-questionnaire</a></p><p><b>status</b>: completed</p><p><b>authored</b>: Jul 23, 2021 2:37:12 AM</p><blockquote><p><b>item</b></p><p><b>linkId</b>: nme1</p><p><b>text</b>: Research Study</p><blockquote><p><b>item</b></p><p><b>linkId</b>: nme1.1</p><p><b>text</b>: Study Title:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme1.3</p><p><b>text</b>: IRB Protocol Number:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme1.4</p><p><b>text</b>: Status:</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2a</p><p><b>text</b>: Site/Organization</p><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2a.1</p><p><b>text</b>: Organization/site where the Adverse Non-Medical Event occurred</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2a.2</p><p><b>text</b>: Organization/site which is recording the Adverse Non-Medical Event</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2b</p><p><b>text</b>: Site Principal Investigator for the site where Adverse Non-Medical Event occurred</p><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2b.1</p><p><b>text</b>: First Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2b.4</p><p><b>text</b>: Last Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2b.5</p><p><b>text</b>: Suffix</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2b.6</p><p><b>text</b>: Degree(s)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2b.2</p><p><b>text</b>: Phone:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme2b.3</p><p><b>text</b>: Email:</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3</p><p><b>text</b>: Report</p><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.1</p><p><b>text</b>: Report Date:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.2</p><p><b>text</b>: Report Status</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.4</p><p><b>text</b>: New information resulted in unexpected change in risks of the research.</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.5</p><p><b>text</b>: New or increased risk</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.6</p><p><b>text</b>: Unanticipated Problem Involving Risk to Participants or Others</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.7</p><p><b>text</b>: Unanticipated Problem</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.8</p><p><b>text</b>: Protocol Deviation (accidental or unintentional)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.9</p><p><b>text</b>: Protocol Deviation (Non-Compliance)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.10</p><p><b>text</b>: A breach of Confidentiality</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.11</p><p><b>text</b>: Breach of Confidentiality</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.12</p><p><b>text</b>: Incarceration of a participant in a protocol not approved to enroll prisoners</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.13</p><p><b>text</b>: Incarceration</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.14</p><p><b>text</b>: Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team.</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.15</p><p><b>text</b>: Participant Complaint</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.16</p><p><b>text</b>: Other Type of Adverse Non-Medical Event</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme3.17</p><p><b>text</b>: Other Type</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme4</p><p><b>text</b>: Reporting</p><blockquote><p><b>item</b></p><p><b>linkId</b>: nme4.1</p><p><b>text</b>: Was the Sponsor notified?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme4.2</p><p><b>text</b>: Notification date:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme4.3</p><p><b>text</b>: Was the IRB notified?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme4.4</p><p><b>text</b>: Notification date:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme4.5</p><p><b>text</b>: Were any Other Parties notified?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme4.6</p><p><b>text</b>: Please list other notified parties</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme5</p><p><b>text</b>: Corrective and Preventative Action Plan</p><blockquote><p><b>item</b></p><p><b>linkId</b>: nme5.1</p><p><b>text</b>: Was a Root Cause analysis performed?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme5.2a</p><p><b>text</b>: If yes, provide determination:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme5.3</p><p><b>text</b>: Was Corrective Action implemented?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme5.4</p><p><b>text</b>: If Corrective Action was implemented or is pending, provide a summary:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme5.5</p><p><b>text</b>: Was Preventitive Action implemented?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme5.6</p><p><b>text</b>: If Preventitive Action was implemented or is pending, provide a summary:</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme6</p><p><b>text</b>: Study Protocol and Informed Consent</p><blockquote><p><b>item</b></p><p><b>linkId</b>: nme6.1a</p><p><b>text</b>: Are changes required to the Study Protocol as a result of this report?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme6.3a</p><p><b>text</b>: Are changes required to the Informed Consent as a result of this report?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme6.5</p><p><b>text</b>: Are notifications or re-consenting of participants required as a result of this change?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: nme6.6</p><p><b>text</b>: If yes, detail how the notification and/or re-consent will occur:</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN00</p><p><b>text</b>: Administrative Use Only</p><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN01</p><p><b>text</b>: Link ID prefix</p></blockquote></blockquote></div>"
];
fhir:QuestionnaireResponse.questionnaire [
fhir:value "https://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevents-questionnaire";
fhir:link <https://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevents-questionnaire>
];
fhir:QuestionnaireResponse.status [ fhir:value "completed"];
fhir:QuestionnaireResponse.authored [ fhir:value "2021-07-23T02:37:12.835Z"^^xsd:dateTime];
fhir:QuestionnaireResponse.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Research Study" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme1.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Study Title:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "The Effect of Drug A." ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme1.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "IRB Protocol Number:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "44567hyujd" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme1.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Status:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
fhir:Coding.code [ fhir:value "nochange" ];
fhir:Coding.display [ fhir:value "No change in research activities" ] ] ] ]
], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2a" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Site/Organization" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2a.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Organization/site where the Adverse Non-Medical Event occurred" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2a.1.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Name of organization/site where the Adverse Non-Medical Event occurred" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Duke" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2a.1.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "City" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Durham" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2a.1.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "State" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "NC" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2a.1.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Country" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "USA" ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2a.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Organization/site which is recording the Adverse Non-Medical Event" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2a.2.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Name of organization/site which is recording the Adverse Non-Medical Event" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Duke Regional Hospital" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2a.2.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "City" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Durham" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2a.2.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "State" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "NC" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2a.2.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Country" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "USA" ] ] ] ]
], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2b" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Site Principal Investigator for the site where Adverse Non-Medical Event occurred" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2b.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "First Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "John" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2b.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Last Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Blake" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2b.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Suffix" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "II" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2b.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Degree(s)" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "MD" ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2b.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Phone:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "9198726765" ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme2b.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Email:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "blake@duke.edu" ] ] ]
], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Report" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Report Date:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-07-22"^^xsd:date ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Report Status" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
fhir:Coding.code [ fhir:value "init" ];
fhir:Coding.display [ fhir:value "Initial" ] ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "New information resulted in unexpected change in risks of the research." ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueBoolean [ fhir:value "true"^^xsd:boolean ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "New or increased risk" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.5.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Date:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-07-22"^^xsd:date ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.5.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Date discovered:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-07-21"^^xsd:date ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.5.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Description:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[Text Description]" ] ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Unanticipated Problem Involving Risk to Participants or Others" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueBoolean [ fhir:value "true"^^xsd:boolean ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Unanticipated Problem" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.7.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Event date:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-07-15"^^xsd:date ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.7.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Date event became aware to study team:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-07-20"^^xsd:date ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.7.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Event Summary:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[Text Description]" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.7.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Was this event Unexpected?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.7.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "If yes, please explain:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[Text Description]" ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.7.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Was this event Related or Possibly Related to participation in the research?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 6;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.7.7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "If yes, please explain:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[Text Description]" ] ] ], [
fhir:index 7;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.7.8" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Does this event suggest that the research places participant(s) or others at a greater Risk of harm than was previously known?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 8;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.7.9" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "If yes, please explain:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[Text Description]" ] ] ] ], [
fhir:index 6;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.8" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Protocol Deviation (accidental or unintentional)" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueBoolean [ fhir:value "true"^^xsd:boolean ] ] ], [
fhir:index 7;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.9" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Protocol Deviation (Non-Compliance)" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.9.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Does the deviation involve any of the following? (Check all that apply)" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.9.4.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Failure to obtain informed consent when IRB deemed required" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueBoolean [ fhir:value "true"^^xsd:boolean ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.9.4.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Modifying the protocol without IRB approval, except to avoid hazard to participants" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueBoolean [ fhir:value "true"^^xsd:boolean ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.9.4.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Conducting research prior to IRB approval, during an IRB suspension or after IRB approval ends" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueBoolean [ fhir:value "true"^^xsd:boolean ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.9.4.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Please explain any Checked items:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[Text Description]" ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.9.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Was the deviation a substantive change from the protocol adversely affecting any of the following? (Check all that apply)" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.9.5.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "The rights, welfare, or safety of the participants" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueBoolean [ fhir:value "true"^^xsd:boolean ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.9.5.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "The integrity of the research area" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueBoolean [ fhir:value "true"^^xsd:boolean ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.9.5.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "The participants' willingness to continue participation" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueBoolean [ fhir:value "true"^^xsd:boolean ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.9.5.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Please explain any Checked items:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[Text Description]" ] ] ] ] ], [
fhir:index 8;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.10" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "A breach of Confidentiality" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueBoolean [ fhir:value "true"^^xsd:boolean ] ] ], [
fhir:index 9;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.11" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Breach of Confidentiality" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.11.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Date breach occurred" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-07-21"^^xsd:date ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.11.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Date discovered:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-07-21"^^xsd:date ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.11.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Description:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[Text Description]" ] ] ] ], [
fhir:index 10;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.12" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Incarceration of a participant in a protocol not approved to enroll prisoners" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueBoolean [ fhir:value "true"^^xsd:boolean ] ] ], [
fhir:index 11;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.13" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Incarceration" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.13.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Date:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-07-14"^^xsd:date ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.13.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Date incarceration was discovered:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-07-14"^^xsd:date ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.13.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Description:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[Text Description]" ] ] ] ], [
fhir:index 12;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.14" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team." ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueBoolean [ fhir:value "true"^^xsd:boolean ] ] ], [
fhir:index 13;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.15" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Participant Complaint" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.15.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Complaint Date:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-07-15"^^xsd:date ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.15.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Date received:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-07-22"^^xsd:date ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.15.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Description:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[Text Description]" ] ] ] ], [
fhir:index 14;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.16" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Other Type of Adverse Non-Medical Event" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueBoolean [ fhir:value "true"^^xsd:boolean ] ] ], [
fhir:index 15;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.17" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Other Type" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.17.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Event date:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-07-07"^^xsd:date ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.17.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Date study team became aware of event:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-07-14"^^xsd:date ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.17.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Event Summary:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[Text Description]" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.17.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Was this Adverse Non-Medical Event Unexpected?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.17.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "If yes, please explain:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[Text Description]" ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.17.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Was this event Related or Possibly Related to participation in the research?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 6;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme3.17.7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "If yes, please explain:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[Text Description]" ] ] ] ]
], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Reporting" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme4.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Was the Sponsor notified?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme4.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Notification date:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-07-22"^^xsd:date ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme4.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Was the IRB notified?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme4.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Notification date:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-07-22"^^xsd:date ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme4.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Were any Other Parties notified?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme4.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Please list other notified parties" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[answer text]" ] ] ]
], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Corrective and Preventative Action Plan" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme5.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Was a Root Cause analysis performed?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
fhir:Coding.code [ fhir:value "completed" ];
fhir:Coding.display [ fhir:value "Done, performed or completed" ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme5.2a" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "If yes, provide determination:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[Text Description]" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme5.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Was Corrective Action implemented?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
fhir:Coding.code [ fhir:value "pending" ];
fhir:Coding.display [ fhir:value "Pending - Currently under development" ] ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme5.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "If Corrective Action was implemented or is pending, provide a summary:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[Text Description]" ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme5.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Was Preventitive Action implemented?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
fhir:Coding.code [ fhir:value "completed" ];
fhir:Coding.display [ fhir:value "Done, performed or completed" ] ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme5.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "If Preventitive Action was implemented or is pending, provide a summary:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[Text Description]" ] ] ]
], [
fhir:index 6;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Study Protocol and Informed Consent" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme6.1a" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Are changes required to the Study Protocol as a result of this report?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme6.3a" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Are changes required to the Informed Consent as a result of this report?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme6.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Are notifications or re-consenting of participants required as a result of this change?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "nme6.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "If yes, detail how the notification and/or re-consent will occur:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "[Text Description]" ] ] ]
], [
fhir:index 7;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "ADMIN00" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Administrative Use Only" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "ADMIN01" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Link ID prefix" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "nme" ] ] ]
].
# - ontology header ------------------------------------------------------------
a owl:Ontology;
owl:imports fhir:fhir.ttl.
IG © 2020+ HL7 International - BR&R Work Group. Package hl7.fhir.us.sirb#0.1.0 based on FHIR 4.0.1. Generated 2021-08-10
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