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 
<QuestionnaireResponse xmlns="http://hl7.org/fhir">
<id value="CONTINUING-REVIEW-QR"/>
<meta>
<versionId value="2"/>
<lastUpdated value="2021-07-28T19:30:37.109+00:00"/>
<source value="#p17nsc0DW6GRC5C3"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></p><p><b>questionnaire</b>: <a href="http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire">http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire</a></p><p><b>status</b>: completed</p><p><b>authored</b>: Jul 27, 2021 3:22:08 PM</p><blockquote><p><b>item</b></p><p><b>linkId</b>: cr1</p><p><b>text</b>: Research Study</p><blockquote><p><b>item</b></p><p><b>linkId</b>: cr1.1</p><p><b>text</b>: Study Title</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr1.2</p><p><b>text</b>: IRB Protocol Number</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr1.3</p><p><b>text</b>: Enrollment Status:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr1.4</p><p><b>text</b>: Intervention Status:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr1.5</p><p><b>text</b>: Study Status:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr1.6</p><p><b>text</b>: Funding Source(check all that are applicable):</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr2</p><p><b>text</b>: Site Principal Investigator</p><blockquote><p><b>item</b></p><p><b>linkId</b>: cr2.1</p><p><b>text</b>: First Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr2.4</p><p><b>text</b>: Last Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr2.6</p><p><b>text</b>: Degree(s)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr2.2</p><p><b>text</b>: Phone</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr2.3</p><p><b>text</b>: Email:</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr3a</p><p><b>text</b>: Report Type</p><blockquote><p><b>item</b></p><p><b>linkId</b>: cr3a.1</p><p><b>text</b>: Is this an initial report?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr3</p><p><b>text</b>: Accrual of Participants</p><blockquote><p><b>item</b></p><p><b>linkId</b>: cr3.1</p><p><b>text</b>: Provide counts for the following:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr3.2</p><p><b>text</b>: Vulnerable Populations</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr4</p><p><b>text</b>: Study Report</p><blockquote><p><b>item</b></p><p><b>linkId</b>: cr4.5</p><p><b>text</b>: Since your last report (or since the study inception for an initial report):</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr5</p><p><b>text</b>: Adverse Events</p><blockquote><p><b>item</b></p><p><b>linkId</b>: cr5.1</p><p><b>text</b>: Have there been any internal or local adverse events in the research?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr5.3</p><p><b>text</b>: Have any protocol deviations or violations occurred in this study?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr6</p><p><b>text</b>: Conflict of Interest</p><blockquote><p><b>item</b></p><p><b>linkId</b>: cr6.1</p><p><b>text</b>: Has there been a change in the financial disclosure status of the Principal Investigator or other members of the Research Staff that has not been reported to the IRB?</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><p><b>item</b></p><p><b>linkId</b>: ADMIN02</p><p><b>text</b>: Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN03</p><p><b>text</b>: ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any</p></blockquote></blockquote></div>
</text>
<questionnaire
value="http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire"/>
<status value="completed"/>
<authored value="2021-07-27T15:22:08.252Z"/>
<item>
<linkId value="cr1"/>
<text value="Research Study"/>
<item>
<linkId value="cr1.1"/>
<text value="Study Title"/>
<answer>
<valueString value="A clinical study of the efficacy of Drug A"/>
</answer>
</item>
<item>
<linkId value="cr1.2"/>
<text value="IRB Protocol Number"/>
<answer>
<valueString value="A1234"/>
</answer>
</item>
<item>
<linkId value="cr1.3"/>
<text value="Enrollment Status:"/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="open"/>
<display value="Open for enrollment"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="cr1.4"/>
<text value="Intervention Status:"/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="continue-meds"/>
<display value="Continuing interventions"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="cr1.5"/>
<text value="Study Status:"/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/research-study-status"/>
<code value="active"/>
<display value="Active"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="cr1.6"/>
<text value="Funding Source(check all that are applicable):"/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="federal"/>
<display value="Federal"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="cr2"/>
<text value="Site Principal Investigator"/>
<item>
<linkId value="cr2.1"/>
<text value="First Name"/>
<answer>
<valueString value="Jane"/>
</answer>
</item>
<item>
<linkId value="cr2.4"/>
<text value="Last Name"/>
<answer>
<valueString value="Doe"/>
</answer>
</item>
<item>
<linkId value="cr2.6"/>
<text value="Degree(s)"/>
<answer>
<valueString value="MD"/>
</answer>
</item>
<item>
<linkId value="cr2.2"/>
<text value="Phone"/>
<answer>
<valueString value="111-555-1212"/>
</answer>
</item>
<item>
<linkId value="cr2.3"/>
<text value="Email:"/>
<answer>
<valueString value="xx@XX.edu"/>
</answer>
</item>
</item>
<item>
<linkId value="cr3a"/>
<text value="Report Type"/>
<item>
<linkId value="cr3a.1"/>
<text value="Is this an initial report?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="cr3"/>
<text value="Accrual of Participants"/>
<item>
<linkId value="cr3.1"/>
<text value="Provide counts for the following:"/>
<item>
<linkId value="cr3.1.1"/>
<text value="Participants enrolled since activation:"/>
<answer>
<valueInteger value="15"/>
</answer>
</item>
<item>
<linkId value="cr3.1.2"/>
<text
value="Participants enrolled since last approval (or since study inception if initial review):"/>
<answer>
<valueInteger value="15"/>
</answer>
</item>
<item>
<linkId value="cr3.1.3"/>
<text value="Participants approved to enroll:"/>
<answer>
<valueInteger value="10"/>
</answer>
</item>
<item>
<linkId value="cr3.1.4"/>
<text value="Participants consented:"/>
<answer>
<valueInteger value="10"/>
</answer>
</item>
<item>
<linkId value="cr3.1.5"/>
<text value="Participants withdrawn:"/>
<answer>
<valueInteger value="1"/>
</answer>
</item>
<item>
<linkId value="cr3.1.6"/>
<text value="Participants lost to contact:"/>
</item>
<item>
<linkId value="cr3.1.7"/>
<text value="Participants with screen failures:"/>
<answer>
<valueInteger value="100"/>
</answer>
</item>
<item>
<linkId value="cr3.1.8"/>
<text value="Participants still active or follow-up:"/>
<answer>
<valueInteger value="9"/>
</answer>
</item>
<item>
<linkId value="cr3.1.9"/>
<text value="Participants completed study:"/>
</item>
<item>
<linkId value="cr3.1.10"/>
<text value="By Sex:"/>
<item>
<linkId value="cr3.1.10.1"/>
<text value="Men:"/>
<answer>
<valueInteger value="4"/>
</answer>
</item>
<item>
<linkId value="cr3.1.10.2"/>
<text value="Women:"/>
<answer>
<valueInteger value="5"/>
</answer>
</item>
</item>
<item>
<linkId value="cr3.1.11"/>
<text value="By Race"/>
<item>
<linkId value="cr3.1.11.1"/>
<text value="White:"/>
<answer>
<valueInteger value="2"/>
</answer>
</item>
<item>
<linkId value="cr3.1.11.2"/>
<text value="Black or African American:"/>
<answer>
<valueInteger value="3"/>
</answer>
</item>
<item>
<linkId value="cr3.1.11.3"/>
<text value="Asian:"/>
<answer>
<valueInteger value="3"/>
</answer>
</item>
<item>
<linkId value="cr3.1.11.5"/>
<text value="Native Hawaiian or other Pacific Islander:"/>
<answer>
<valueInteger value="1"/>
</answer>
</item>
</item>
<item>
<linkId value="cr3.1.12"/>
<text value="By Ethnicity"/>
<item>
<linkId value="cr3.1.12.1"/>
<text value="Hispanic or Latino:"/>
<answer>
<valueInteger value="2"/>
</answer>
</item>
<item>
<linkId value="cr3.1.12.2"/>
<text value="Not Hispanic or Latino:"/>
<answer>
<valueInteger value="7"/>
</answer>
</item>
</item>
</item>
<item>
<linkId value="cr3.2"/>
<text value="Vulnerable Populations"/>
<item>
<linkId value="cr3.2.1"/>
<text value="Number of potentially vulnerable participants enrolled:"/>
</item>
</item>
</item>
<item>
<linkId value="cr4"/>
<text value="Study Report"/>
<item>
<linkId value="cr4.5"/>
<text
value="Since your last report (or since the study inception for an initial report):"/>
<item>
<linkId value="cr4.5.1"/>
<text value="Summarize the study progress:"/>
<answer>
<valueString value="Study is started, continuing"/>
</answer>
</item>
<item>
<linkId value="cr4.5.2"/>
<text value="Have participants experienced any benefits?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="cr4.5.4"/>
<text value="Have participants been withdrawn from this study?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="cr4.5.5"/>
<text value="If yes, please summarize the withdrawals:"/>
<answer>
<valueString value="Participant Choice"/>
</answer>
</item>
<item>
<linkId value="cr4.5.6"/>
<text
value="Have any participants or others complained about the research?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="cr4.5.8"/>
<text
value="Has any new and relevant literature been published related to the risks or benefits associated with this research?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="cr4.5.10"/>
<text value="Have there been any interim findings?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="cr4.5.12"/>
<text value="Have there been any multi-center trial reports?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="cr4.5.14"/>
<text value="Have there been any data safety monitoring board reports?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="cr4.5.16"/>
<text
value="In the opinion of the Principal Investigator, have the risks or potential benefits changed?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="cr4.5.18"/>
<text
value="Has an audit of the research been conducted by a federal agency or sponsor?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="cr4.5.19"/>
<text
value="Have there been any presentations or publications (including abstracts) from this research?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="cr4.5.20"/>
<text
value="Have there been any substantial changes to the study (protocol, consent forms, or other study documents) or to the risk-benefit assessment?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="cr4.5.21"/>
<text value="If yes, please summarize the changes:"/>
<answer>
<valueString value="Modified allowance for blood draw amount."/>
</answer>
</item>
<item>
<linkId value="cr4.5.22"/>
<text
value="Was informed consent obtained from all enrolled participants?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="cr4.5.23"/>
<text
value="Has there been any other relevant information regarding this protocol?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
</item>
</item>
<item>
<linkId value="cr5"/>
<text value="Adverse Events"/>
<item>
<linkId value="cr5.1"/>
<text
value="Have there been any internal or local adverse events in the research?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="cr5.3"/>
<text
value="Have any protocol deviations or violations occurred in this study?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="cr6"/>
<text value="Conflict of Interest"/>
<item>
<linkId value="cr6.1"/>
<text
value="Has there been a change in the financial disclosure status of the Principal Investigator or other members of the Research Staff that has not been reported to the IRB?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="ADMIN00"/>
<text value="Administrative Use Only"/>
<item>
<linkId value="ADMIN01"/>
<text value="Link ID prefix"/>
<answer>
<valueString value="cr"/>
</answer>
</item>
<item>
<linkId value="ADMIN02"/>
<text
value="Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any"/>
<answer>
<valueString value="temporarily unavailable"/>
</answer>
</item>
<item>
<linkId value="ADMIN03"/>
<text
value="ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any"/>
<answer>
<valueString value="temporarily unavailable"/>
</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
Links: Table of Contents |
QA Report
| Version History |
Search |
|
Propose a change