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 
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<lastUpdated value="2021-07-27T02:23:03.257+00:00"/>
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<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>
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<questionnaire
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<status value="completed"/>
<authored value="2021-07-23T02:37:12.835Z"/>
<item>
<linkId value="nme1"/>
<text value="Research Study"/>
<item>
<linkId value="nme1.1"/>
<text value="Study Title:"/>
<answer>
<valueString value="The Effect of Drug A."/>
</answer>
</item>
<item>
<linkId value="nme1.3"/>
<text value="IRB Protocol Number:"/>
<answer>
<valueString value="44567hyujd"/>
</answer>
</item>
<item>
<linkId value="nme1.4"/>
<text value="Status:"/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="nochange"/>
<display value="No change in research activities"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="nme2a"/>
<text value="Site/Organization"/>
<item>
<linkId value="nme2a.1"/>
<text
value="Organization/site where the Adverse Non-Medical Event occurred"/>
<item>
<linkId value="nme2a.1.1"/>
<text
value="Name of organization/site where the Adverse Non-Medical Event occurred"/>
<answer>
<valueString value="Duke"/>
</answer>
</item>
<item>
<linkId value="nme2a.1.2"/>
<text value="City"/>
<answer>
<valueString value="Durham"/>
</answer>
</item>
<item>
<linkId value="nme2a.1.3"/>
<text value="State"/>
<answer>
<valueString value="NC"/>
</answer>
</item>
<item>
<linkId value="nme2a.1.4"/>
<text value="Country"/>
<answer>
<valueString value="USA"/>
</answer>
</item>
</item>
<item>
<linkId value="nme2a.2"/>
<text
value="Organization/site which is recording the Adverse Non-Medical Event"/>
<item>
<linkId value="nme2a.2.1"/>
<text
value="Name of organization/site which is recording the Adverse Non-Medical Event"/>
<answer>
<valueString value="Duke Regional Hospital"/>
</answer>
</item>
<item>
<linkId value="nme2a.2.2"/>
<text value="City"/>
<answer>
<valueString value="Durham"/>
</answer>
</item>
<item>
<linkId value="nme2a.2.3"/>
<text value="State"/>
<answer>
<valueString value="NC"/>
</answer>
</item>
<item>
<linkId value="nme2a.2.4"/>
<text value="Country"/>
<answer>
<valueString value="USA"/>
</answer>
</item>
</item>
</item>
<item>
<linkId value="nme2b"/>
<text
value="Site Principal Investigator for the site where Adverse Non-Medical Event occurred"/>
<item>
<linkId value="nme2b.1"/>
<text value="First Name"/>
<answer>
<valueString value="John"/>
</answer>
</item>
<item>
<linkId value="nme2b.4"/>
<text value="Last Name"/>
<answer>
<valueString value="Blake"/>
</answer>
</item>
<item>
<linkId value="nme2b.5"/>
<text value="Suffix"/>
<answer>
<valueString value="II"/>
</answer>
</item>
<item>
<linkId value="nme2b.6"/>
<text value="Degree(s)"/>
<answer>
<valueString value="MD"/>
</answer>
</item>
<item>
<linkId value="nme2b.2"/>
<text value="Phone:"/>
<answer>
<valueString value="9198726765"/>
</answer>
</item>
<item>
<linkId value="nme2b.3"/>
<text value="Email:"/>
<answer>
<valueString value="blake@duke.edu"/>
</answer>
</item>
</item>
<item>
<linkId value="nme3"/>
<text value="Report"/>
<item>
<linkId value="nme3.1"/>
<text value="Report Date:"/>
<answer>
<valueDate value="2021-07-22"/>
</answer>
</item>
<item>
<linkId value="nme3.2"/>
<text value="Report Status"/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="init"/>
<display value="Initial"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="nme3.4"/>
<text
value="New information resulted in unexpected change in risks of the research."/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="nme3.5"/>
<text value="New or increased risk"/>
<item>
<linkId value="nme3.5.1"/>
<text value="Date:"/>
<answer>
<valueDate value="2021-07-22"/>
</answer>
</item>
<item>
<linkId value="nme3.5.2"/>
<text value="Date discovered:"/>
<answer>
<valueDate value="2021-07-21"/>
</answer>
</item>
<item>
<linkId value="nme3.5.3"/>
<text value="Description:"/>
<answer>
<valueString value="[Text Description]"/>
</answer>
</item>
</item>
<item>
<linkId value="nme3.6"/>
<text
value="Unanticipated Problem Involving Risk to Participants or Others"/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="nme3.7"/>
<text value="Unanticipated Problem"/>
<item>
<linkId value="nme3.7.1"/>
<text value="Event date:"/>
<answer>
<valueDate value="2021-07-15"/>
</answer>
</item>
<item>
<linkId value="nme3.7.2"/>
<text value="Date event became aware to study team:"/>
<answer>
<valueDate value="2021-07-20"/>
</answer>
</item>
<item>
<linkId value="nme3.7.3"/>
<text value="Event Summary:"/>
<answer>
<valueString value="[Text Description]"/>
</answer>
</item>
<item>
<linkId value="nme3.7.4"/>
<text value="Was this event Unexpected?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="nme3.7.5"/>
<text value="If yes, please explain:"/>
<answer>
<valueString value="[Text Description]"/>
</answer>
</item>
<item>
<linkId value="nme3.7.6"/>
<text
value="Was this event Related or Possibly Related to participation in the research?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="nme3.7.7"/>
<text value="If yes, please explain:"/>
<answer>
<valueString value="[Text Description]"/>
</answer>
</item>
<item>
<linkId value="nme3.7.8"/>
<text
value="Does this event suggest that the research places participant(s) or others at a greater Risk of harm than was previously known?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="nme3.7.9"/>
<text value="If yes, please explain:"/>
<answer>
<valueString value="[Text Description]"/>
</answer>
</item>
</item>
<item>
<linkId value="nme3.8"/>
<text value="Protocol Deviation (accidental or unintentional)"/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="nme3.9"/>
<text value="Protocol Deviation (Non-Compliance)"/>
<item>
<linkId value="nme3.9.4"/>
<text
value="Does the deviation involve any of the following? (Check all that apply)"/>
<item>
<linkId value="nme3.9.4.1"/>
<text
value="Failure to obtain informed consent when IRB deemed required"/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="nme3.9.4.2"/>
<text
value="Modifying the protocol without IRB approval, except to avoid hazard to participants"/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="nme3.9.4.3"/>
<text
value="Conducting research prior to IRB approval, during an IRB suspension or after IRB approval ends"/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="nme3.9.4.4"/>
<text value="Please explain any Checked items:"/>
<answer>
<valueString value="[Text Description]"/>
</answer>
</item>
</item>
<item>
<linkId value="nme3.9.5"/>
<text
value="Was the deviation a substantive change from the protocol adversely affecting any of the following? (Check all that apply)"/>
<item>
<linkId value="nme3.9.5.1"/>
<text value="The rights, welfare, or safety of the participants"/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="nme3.9.5.2"/>
<text value="The integrity of the research area"/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="nme3.9.5.3"/>
<text
value="The participants' willingness to continue participation"/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="nme3.9.5.4"/>
<text value="Please explain any Checked items:"/>
<answer>
<valueString value="[Text Description]"/>
</answer>
</item>
</item>
</item>
<item>
<linkId value="nme3.10"/>
<text value="A breach of Confidentiality"/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="nme3.11"/>
<text value="Breach of Confidentiality"/>
<item>
<linkId value="nme3.11.1"/>
<text value="Date breach occurred"/>
<answer>
<valueDate value="2021-07-21"/>
</answer>
</item>
<item>
<linkId value="nme3.11.2"/>
<text value="Date discovered:"/>
<answer>
<valueDate value="2021-07-21"/>
</answer>
</item>
<item>
<linkId value="nme3.11.3"/>
<text value="Description:"/>
<answer>
<valueString value="[Text Description]"/>
</answer>
</item>
</item>
<item>
<linkId value="nme3.12"/>
<text
value="Incarceration of a participant in a protocol not approved to enroll prisoners"/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="nme3.13"/>
<text value="Incarceration"/>
<item>
<linkId value="nme3.13.1"/>
<text value="Date:"/>
<answer>
<valueDate value="2021-07-14"/>
</answer>
</item>
<item>
<linkId value="nme3.13.2"/>
<text value="Date incarceration was discovered:"/>
<answer>
<valueDate value="2021-07-14"/>
</answer>
</item>
<item>
<linkId value="nme3.13.3"/>
<text value="Description:"/>
<answer>
<valueString value="[Text Description]"/>
</answer>
</item>
</item>
<item>
<linkId value="nme3.14"/>
<text
value="Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team."/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="nme3.15"/>
<text value="Participant Complaint"/>
<item>
<linkId value="nme3.15.1"/>
<text value="Complaint Date:"/>
<answer>
<valueDate value="2021-07-15"/>
</answer>
</item>
<item>
<linkId value="nme3.15.2"/>
<text value="Date received:"/>
<answer>
<valueDate value="2021-07-22"/>
</answer>
</item>
<item>
<linkId value="nme3.15.3"/>
<text value="Description:"/>
<answer>
<valueString value="[Text Description]"/>
</answer>
</item>
</item>
<item>
<linkId value="nme3.16"/>
<text value="Other Type of Adverse Non-Medical Event"/>
<answer>
<valueBoolean value="true"/>
</answer>
</item>
<item>
<linkId value="nme3.17"/>
<text value="Other Type"/>
<item>
<linkId value="nme3.17.1"/>
<text value="Event date:"/>
<answer>
<valueDate value="2021-07-07"/>
</answer>
</item>
<item>
<linkId value="nme3.17.2"/>
<text value="Date study team became aware of event:"/>
<answer>
<valueDate value="2021-07-14"/>
</answer>
</item>
<item>
<linkId value="nme3.17.3"/>
<text value="Event Summary:"/>
<answer>
<valueString value="[Text Description]"/>
</answer>
</item>
<item>
<linkId value="nme3.17.4"/>
<text value="Was this Adverse Non-Medical Event Unexpected?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="nme3.17.5"/>
<text value="If yes, please explain:"/>
<answer>
<valueString value="[Text Description]"/>
</answer>
</item>
<item>
<linkId value="nme3.17.6"/>
<text
value="Was this event Related or Possibly Related to participation in the research?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="nme3.17.7"/>
<text value="If yes, please explain:"/>
<answer>
<valueString value="[Text Description]"/>
</answer>
</item>
</item>
</item>
<item>
<linkId value="nme4"/>
<text value="Reporting"/>
<item>
<linkId value="nme4.1"/>
<text value="Was the Sponsor notified?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="nme4.2"/>
<text value="Notification date:"/>
<answer>
<valueDate value="2021-07-22"/>
</answer>
</item>
<item>
<linkId value="nme4.3"/>
<text value="Was the IRB notified?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="nme4.4"/>
<text value="Notification date:"/>
<answer>
<valueDate value="2021-07-22"/>
</answer>
</item>
<item>
<linkId value="nme4.5"/>
<text value="Were any Other Parties notified?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="nme4.6"/>
<text value="Please list other notified parties"/>
<answer>
<valueString value="[answer text]"/>
</answer>
</item>
</item>
<item>
<linkId value="nme5"/>
<text value="Corrective and Preventative Action Plan"/>
<item>
<linkId value="nme5.1"/>
<text value="Was a Root Cause analysis performed?"/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="completed"/>
<display value="Done, performed or completed"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="nme5.2a"/>
<text value="If yes, provide determination:"/>
<answer>
<valueString value="[Text Description]"/>
</answer>
</item>
<item>
<linkId value="nme5.3"/>
<text value="Was Corrective Action implemented?"/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="pending"/>
<display value="Pending - Currently under development"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="nme5.4"/>
<text
value="If Corrective Action was implemented or is pending, provide a summary:"/>
<answer>
<valueString value="[Text Description]"/>
</answer>
</item>
<item>
<linkId value="nme5.5"/>
<text value="Was Preventitive Action implemented?"/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="completed"/>
<display value="Done, performed or completed"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="nme5.6"/>
<text
value="If Preventitive Action was implemented or is pending, provide a summary:"/>
<answer>
<valueString value="[Text Description]"/>
</answer>
</item>
</item>
<item>
<linkId value="nme6"/>
<text value="Study Protocol and Informed Consent"/>
<item>
<linkId value="nme6.1a"/>
<text
value="Are changes required to the Study Protocol as a result of this report?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="nme6.3a"/>
<text
value="Are changes required to the Informed Consent as a result of this report?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="nme6.5"/>
<text
value="Are notifications or re-consenting of participants required as a result of this change?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="nme6.6"/>
<text
value="If yes, detail how the notification and/or re-consent will occur:"/>
<answer>
<valueString value="[Text Description]"/>
</answer>
</item>
</item>
<item>
<linkId value="ADMIN00"/>
<text value="Administrative Use Only"/>
<item>
<linkId value="ADMIN01"/>
<text value="Link ID prefix"/>
<answer>
<valueString value="nme"/>
</answer>
</item>
</item>
</QuestionnaireResponse>
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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