Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use United States of America flag

This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v1.0.0: STU 1) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Example QuestionnaireResponse: Example Continuing Review Questionnaire Response

LinkIdTextDefinitionAnswerdoco
.. continuing-review-populate-exampleQRQuestionnaireResponse
... cr1Research Study
.... cr1.1Study TitleStudy of Drug A for arthritis
.... cr1.2IRB Protocol NumberPRO098765
.... cr1.3Enrollment StatusTemporary Codes open: Open for enrollment
.... cr1.4Intervention StatusTemporary Codes continue-meds: Continuing interventions
.... cr1.5Study StatusResearchStudyStatus active: Active
.... cr1.6Funding Source(check all that are applicable)Temporary Codes federal: Federal
... cr12sIRB (Reviewing Institution)
.... cr12.1sIRB (Reviewing Institution) NameX Pharmaceutical Research IRB
... cr9Submission Type
.... cr9.1Is this Continuing Review Form being submitted by the lead PI site on behalf of all of the relying sites?expandedYes-NoIndicator Y: Yes
.... ExternalDataFor_cr9.2External Data For linkId cr9.2
... cr11Site Principal Investigator Institution
.... cr11.1Site Principal Investigator Institution NameSample University Medical Center
... cr2Site Principal Investigator
.... cr2.1First NameJane
.... cr2.4Last NameDoe
.... cr2.6Degree(s)MD
.... cr2.10Site Principal Investigator Department Name or DivisionOrthopedics
.... cr2.2Phone567-123-1234
.... cr2.3Emaildrjanedoe@sampleuniversity.edu
... cr3Accrual of Participants
.... cr3.1Provide counts for the following
..... cr3.1.1Participants enrolled since activation
...... cr3.1.1.1Previous Accrual10
...... cr3.1.1.2Additional enrollees this approval period20
...... cr3.1.1.3Total30
..... cr3.1.2Participants enrolled since last approval
...... cr3.1.2.1Previous Accrual10
...... cr3.1.2.2Additional enrollees this approval period10
...... cr3.1.2.3Total20
..... cr3.1.3Participants approved to enroll
...... cr3.1.3.1Previous Accrual10
...... cr3.1.3.2Additional enrollees this approval period10
...... cr3.1.3.3Total20
..... cr3.1.4Participants consented
...... cr3.1.4.1Previous Accrual10
...... cr3.1.4.2Additional enrollees this approval period10
...... cr3.1.4.3Total20
..... cr3.1.5Participants withdrawn
...... cr3.1.5.1Previous Accrual0
...... cr3.1.5.2Additional enrollees this approval period0
...... cr3.1.5.3Total0
..... cr3.1.6Participants lost to contact
...... cr3.1.6.1Previous Accrual0
...... cr3.1.6.2Additional enrollees this approval period0
...... cr3.1.6.3Total0
..... cr3.1.7Participants with screen failures
...... cr3.1.7.1Previous Accrual0
...... cr3.1.7.2Additional enrollees this approval period0
...... cr3.1.7.3Total0
..... cr3.1.8Participants still active or follow-up
...... cr3.1.8.1Previous Accrual10
...... cr3.1.8.2Additional enrollees this approval period10
...... cr3.1.8.3Total20
..... cr3.1.9Participants completed study
...... cr3.1.9.1Previous Accrual5
...... cr3.1.9.2Additional enrollees this approval period0
...... cr3.1.9.3Total5
..... cr3.1.10By Sex
...... cr3.1.10.1Men
....... cr3.1.10.1.1Previous Accrual6
....... cr3.1.10.1.2Additional enrollees this approval period5
....... cr3.1.10.1.3Total11
...... cr3.1.10.2Women
....... cr3.1.10.2.1Previous Accrual4
....... cr3.1.10.2.2Additional enrollees this approval period15
....... cr3.1.10.2.3Total19
..... cr3.1.11By Race
...... cr3.1.11.1White
....... cr3.1.11.1.1Previous Accrual3
....... cr3.1.11.1.2Additional enrollees this approval period3
....... cr3.1.11.1.3Total6
...... cr3.1.11.2Black or African American
....... cr3.1.11.2.1Previous Accrual3
....... cr3.1.11.2.2Additional enrollees this approval period4
....... cr3.1.11.2.3Total7
...... cr3.1.11.3Asian
....... cr3.1.11.3.1Previous Accrual2
....... cr3.1.11.3.2Additional enrollees this approval period3
....... cr3.1.11.3.3Total5
...... cr3.1.11.4American Indian or Alaska Native
....... cr3.1.11.4.1Previous Accrual1
....... cr3.1.11.4.2Additional enrollees this approval period0
....... cr3.1.11.4.3Total1
...... cr3.1.11.5Native Hawaiian or other Pacific Islander
....... cr3.1.11.5.1Previous Accrual0
....... cr3.1.11.5.2Additional enrollees this approval period1
....... cr3.1.11.5.3Total1
...... cr3.1.11.6More than One Race
....... cr3.1.11.6.1Previous Accrual2
....... cr3.1.11.6.2Additional enrollees this approval period0
....... cr3.1.11.6.3Total2
...... cr3.1.11.7Unknown/Not Reported
....... cr3.1.11.7.1Previous Accrual0
....... cr3.1.11.7.2Additional enrollees this approval period0
....... cr3.1.11.7.3Total0
..... cr3.1.12By Ethnicity
...... cr3.1.12.1Hispanic or Latino
....... cr3.1.12.1.1Previous Accrual4
....... cr3.1.12.1.2Additional enrollees this approval period5
....... cr3.1.12.1.3Total9
...... cr3.1.12.2Not Hispanic or Latino
....... cr3.1.12.2.1Previous Accrual4
....... cr3.1.12.2.2Additional enrollees this approval period5
....... cr3.1.12.2.3Total9
...... cr3.1.12.3Unknown/Not Reported
....... cr3.1.12.3.1Previous Accrual0
....... cr3.1.12.3.2Additional enrollees this approval period0
....... cr3.1.12.3.3Total0
.... cr3.2Vulnerable Populations
..... cr3.2.1Number of potentially vulnerable participants enrolled
...... cr3.2.1.1Previous Accrual0
...... cr3.2.1.2Additional enrollees this approval period0
...... cr3.2.1.3Total0
..... cr3.2.2Check the applicable checkboxes if these groups are represented in the columns above
...... cr3.2.2.3EmployeesTemporary Codes AdditionalEnrollees: Additional enrollees this approval period
...... cr3.2.2.8StudentsTemporary Codes PreviousAccrual: Previous Accrual
... cr4Study Report
.... cr4.5Since your last report:
..... cr4.5.1Summarize the study progress[answer]
..... cr4.5.2Have participants experienced any benefits?expandedYes-NoIndicator Y: Yes
..... cr4.5.3If yes, please summarize the benefits:[answer]
..... cr4.5.4Have participants been withdrawn from this study?expandedYes-NoIndicator Y: Yes
..... cr4.5.5If yes, please summarize the withdrawals:[answer]
..... cr4.5.6Have any participants or others complained about the research?expandedYes-NoIndicator Y: Yes
..... cr4.5.7If yes, please summarize the complaints:[answer]
..... cr4.5.8Has any new and relevant literature been published related to the risks or benefits associated with this research?expandedYes-NoIndicator Y: Yes
..... cr4.5.9If yes, please summarize relevance to study:[answer]
..... cr4.5.10Have there been any interim findings?expandedYes-NoIndicator Y: Yes
..... cr4.5.11If yes, please summarize findings:[answer]
..... cr4.5.12Have there been any multi-center trial reports?expandedYes-NoIndicator Y: Yes
..... cr4.5.13If yes, please summarize findings and recommendations[answer]
..... cr4.5.14Have there been any data safety monitoring board reports?expandedYes-NoIndicator Y: Yes
..... cr4.5.15If yes, please summarize findings and recommendations:[answer]
..... cr4.5.16In the opinion of the Principal Investigator, have the risks or potential benefits changed?expandedYes-NoIndicator Y: Yes
..... cr4.5.17If yes, please summarize the changes:[answer]
..... cr4.5.18Has an audit of the research been conducted by a federal agency or sponsor?expandedYes-NoIndicator Y: Yes
..... cr4.5.19Have there been any presentations or publications (including abstracts) from this research?expandedYes-NoIndicator Y: Yes
..... cr4.5.20Have there been any substantial changes to the study (protocol, consent forms, or other study documents) or to the risk-benefit assessment?expandedYes-NoIndicator Y: Yes
..... cr4.5.21If yes, please summarize the changes:[answer]
..... cr4.5.22Was informed consent obtained from all enrolled participants?expandedYes-NoIndicator N: No
..... cr4.5.23Has there been any other relevant information regarding this protocol?expandedYes-NoIndicator Y: Yes
..... cr4.5.24If yes, please summarize:[answer]
... cr5Adverse Events
.... cr5.1Have there been any internal or local adverse events in the research?expandedYes-NoIndicator Y: Yes
.... cr5.2Did these adverse events occur at the frequency and level of severity expected?expandedYes-NoIndicator Y: Yes
.... cr5.3Have any protocol deviations or violations occurred in this study?expandedYes-NoIndicator Y: Yes
.... cr5.13If yes, please describe the protocol deviations or violations[answer]
... cr6Conflict of Interest
.... cr6.1Has 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?expandedYes-NoIndicator Y: Yes
.... cr6.2If yes, please explain:[answer]
... cr17Attachments
.... cr17.2AttachmentNo display for Attachment
... ADMIN00Administrative Use Only
.... ADMIN01Link ID prefixcr
.... ADMIN02Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if anyinitiate-study-populate-exampleQR
.... ADMIN03ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if anyResearchStudyExample-sIRB

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