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 QuestionnaireResponse: Example Continuing Review Questionnaire Response

LinkId | Text | Definition | Answer
--- | --- | --- | ---
continuing-review-populate-exampleQR |  | QuestionnaireResponse |
cr1 | Research Study |  |
cr1.1 | Study Title |  | Study of Drug A for arthritis
cr1.2 | IRB Protocol Number |  | PRO098765
cr1.3 | Enrollment Status |  | Temporary Codes open: Open for enrollment
cr1.4 | Intervention Status |  | Temporary Codes continue-meds: Continuing interventions
cr1.5 | Study Status |  | ResearchStudyStatus active: Active
cr1.6 | Funding Source(check all that are applicable) |  | Temporary Codes federal: Federal
cr12 | sIRB (Reviewing Institution) |  |
cr12.1 | sIRB (Reviewing Institution) Name |  | X Pharmaceutical Research IRB
cr9 | Submission Type |  |
cr9.1 | Is this Continuing Review Form being submitted by the lead PI site on behalf of all of the relying sites? |  | expandedYes-NoIndicator Y: Yes
ExternalDataFor_cr9.2 | External Data For linkId cr9.2 |  |
cr11 | Site Principal Investigator Institution |  |
cr11.1 | Site Principal Investigator Institution Name |  | Sample University Medical Center
cr2 | Site Principal Investigator |  |
cr2.1 | First Name |  | Jane
cr2.4 | Last Name |  | Doe
cr2.6 | Degree(s) |  | MD
cr2.10 | Site Principal Investigator Department Name or Division |  | Orthopedics
cr2.2 | Phone |  | 567-123-1234
cr2.3 | Email |  | drjanedoe@sampleuniversity.edu
cr3 | Accrual of Participants |  |
cr3.1 | Provide counts for the following |  |
cr3.1.1 | Participants enrolled since activation |  |
cr3.1.1.1 | Previous Accrual |  | 10
cr3.1.1.2 | Additional enrollees this approval period |  | 20
cr3.1.1.3 | Total |  | 30
cr3.1.2 | Participants enrolled since last approval |  |
cr3.1.2.1 | Previous Accrual |  | 10
cr3.1.2.2 | Additional enrollees this approval period |  | 10
cr3.1.2.3 | Total |  | 20
cr3.1.3 | Participants approved to enroll |  |
cr3.1.3.1 | Previous Accrual |  | 10
cr3.1.3.2 | Additional enrollees this approval period |  | 10
cr3.1.3.3 | Total |  | 20
cr3.1.4 | Participants consented |  |
cr3.1.4.1 | Previous Accrual |  | 10
cr3.1.4.2 | Additional enrollees this approval period |  | 10
cr3.1.4.3 | Total |  | 20
cr3.1.5 | Participants withdrawn |  |
cr3.1.5.1 | Previous Accrual |  | 0
cr3.1.5.2 | Additional enrollees this approval period |  | 0
cr3.1.5.3 | Total |  | 0
cr3.1.6 | Participants lost to contact |  |
cr3.1.6.1 | Previous Accrual |  | 0
cr3.1.6.2 | Additional enrollees this approval period |  | 0
cr3.1.6.3 | Total |  | 0
cr3.1.7 | Participants with screen failures |  |
cr3.1.7.1 | Previous Accrual |  | 0
cr3.1.7.2 | Additional enrollees this approval period |  | 0
cr3.1.7.3 | Total |  | 0
cr3.1.8 | Participants still active or follow-up |  |
cr3.1.8.1 | Previous Accrual |  | 10
cr3.1.8.2 | Additional enrollees this approval period |  | 10
cr3.1.8.3 | Total |  | 20
cr3.1.9 | Participants completed study |  |
cr3.1.9.1 | Previous Accrual |  | 5
cr3.1.9.2 | Additional enrollees this approval period |  | 0
cr3.1.9.3 | Total |  | 5
cr3.1.10 | By Sex |  |
cr3.1.10.1 | Men |  |
cr3.1.10.1.1 | Previous Accrual |  | 6
cr3.1.10.1.2 | Additional enrollees this approval period |  | 5
cr3.1.10.1.3 | Total |  | 11
cr3.1.10.2 | Women |  |
cr3.1.10.2.1 | Previous Accrual |  | 4
cr3.1.10.2.2 | Additional enrollees this approval period |  | 15
cr3.1.10.2.3 | Total |  | 19
cr3.1.11 | By Race |  |
cr3.1.11.1 | White |  |
cr3.1.11.1.1 | Previous Accrual |  | 3
cr3.1.11.1.2 | Additional enrollees this approval period |  | 3
cr3.1.11.1.3 | Total |  | 6
cr3.1.11.2 | Black or African American |  |
cr3.1.11.2.1 | Previous Accrual |  | 3
cr3.1.11.2.2 | Additional enrollees this approval period |  | 4
cr3.1.11.2.3 | Total |  | 7
cr3.1.11.3 | Asian |  |
cr3.1.11.3.1 | Previous Accrual |  | 2
cr3.1.11.3.2 | Additional enrollees this approval period |  | 3
cr3.1.11.3.3 | Total |  | 5
cr3.1.11.4 | American Indian or Alaska Native |  |
cr3.1.11.4.1 | Previous Accrual |  | 1
cr3.1.11.4.2 | Additional enrollees this approval period |  | 0
cr3.1.11.4.3 | Total |  | 1
cr3.1.11.5 | Native Hawaiian or other Pacific Islander |  |
cr3.1.11.5.1 | Previous Accrual |  | 0
cr3.1.11.5.2 | Additional enrollees this approval period |  | 1
cr3.1.11.5.3 | Total |  | 1
cr3.1.11.6 | More than One Race |  |
cr3.1.11.6.1 | Previous Accrual |  | 2
cr3.1.11.6.2 | Additional enrollees this approval period |  | 0
cr3.1.11.6.3 | Total |  | 2
cr3.1.11.7 | Unknown/Not Reported |  |
cr3.1.11.7.1 | Previous Accrual |  | 0
cr3.1.11.7.2 | Additional enrollees this approval period |  | 0
cr3.1.11.7.3 | Total |  | 0
cr3.1.12 | By Ethnicity |  |
cr3.1.12.1 | Hispanic or Latino |  |
cr3.1.12.1.1 | Previous Accrual |  | 4
cr3.1.12.1.2 | Additional enrollees this approval period |  | 5
cr3.1.12.1.3 | Total |  | 9
cr3.1.12.2 | Not Hispanic or Latino |  |
cr3.1.12.2.1 | Previous Accrual |  | 4
cr3.1.12.2.2 | Additional enrollees this approval period |  | 5
cr3.1.12.2.3 | Total |  | 9
cr3.1.12.3 | Unknown/Not Reported |  |
cr3.1.12.3.1 | Previous Accrual |  | 0
cr3.1.12.3.2 | Additional enrollees this approval period |  | 0
cr3.1.12.3.3 | Total |  | 0
cr3.2 | Vulnerable Populations |  |
cr3.2.1 | Number of potentially vulnerable participants enrolled |  |
cr3.2.1.1 | Previous Accrual |  | 0
cr3.2.1.2 | Additional enrollees this approval period |  | 0
cr3.2.1.3 | Total |  | 0
cr3.2.2 | Check the applicable checkboxes if these groups are represented in the columns above |  |
cr3.2.2.3 | Employees |  | Temporary Codes AdditionalEnrollees: Additional enrollees this approval period
cr3.2.2.8 | Students |  | Temporary Codes PreviousAccrual: Previous Accrual
cr4 | Study Report |  |
cr4.5 | Since your last report: |  |
cr4.5.1 | Summarize the study progress |  | [answer]
cr4.5.2 | Have participants experienced any benefits? |  | expandedYes-NoIndicator Y: Yes
cr4.5.3 | If yes, please summarize the benefits: |  | [answer]
cr4.5.4 | Have participants been withdrawn from this study? |  | expandedYes-NoIndicator Y: Yes
cr4.5.5 | If yes, please summarize the withdrawals: |  | [answer]
cr4.5.6 | Have any participants or others complained about the research? |  | expandedYes-NoIndicator Y: Yes
cr4.5.7 | If yes, please summarize the complaints: |  | [answer]
cr4.5.8 | Has any new and relevant literature been published related to the risks or benefits associated with this research? |  | expandedYes-NoIndicator Y: Yes
cr4.5.9 | If yes, please summarize relevance to study: |  | [answer]
cr4.5.10 | Have there been any interim findings? |  | expandedYes-NoIndicator Y: Yes
cr4.5.11 | If yes, please summarize findings: |  | [answer]
cr4.5.12 | Have there been any multi-center trial reports? |  | expandedYes-NoIndicator Y: Yes
cr4.5.13 | If yes, please summarize findings and recommendations |  | [answer]
cr4.5.14 | Have there been any data safety monitoring board reports? |  | expandedYes-NoIndicator Y: Yes
cr4.5.15 | If yes, please summarize findings and recommendations: |  | [answer]
cr4.5.16 | In the opinion of the Principal Investigator, have the risks or potential benefits changed? |  | expandedYes-NoIndicator Y: Yes
cr4.5.17 | If yes, please summarize the changes: |  | [answer]
cr4.5.18 | Has an audit of the research been conducted by a federal agency or sponsor? |  | expandedYes-NoIndicator Y: Yes
cr4.5.19 | Have there been any presentations or publications (including abstracts) from this research? |  | expandedYes-NoIndicator Y: Yes
cr4.5.20 | Have 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
cr4.5.21 | If yes, please summarize the changes: |  | [answer]
cr4.5.22 | Was informed consent obtained from all enrolled participants? |  | expandedYes-NoIndicator N: No
cr4.5.23 | Has there been any other relevant information regarding this protocol? |  | expandedYes-NoIndicator Y: Yes
cr4.5.24 | If yes, please summarize: |  | [answer]
cr5 | Adverse Events |  |
cr5.1 | Have there been any internal or local adverse events in the research? |  | expandedYes-NoIndicator Y: Yes
cr5.2 | Did these adverse events occur at the frequency and level of severity expected? |  | expandedYes-NoIndicator Y: Yes
cr5.3 | Have any protocol deviations or violations occurred in this study? |  | expandedYes-NoIndicator Y: Yes
cr5.13 | If yes, please describe the protocol deviations or violations |  | [answer]
cr6 | Conflict of Interest |  |
cr6.1 | 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? |  | expandedYes-NoIndicator Y: Yes
cr6.2 | If yes, please explain: |  | [answer]
cr17 | Attachments |  |
cr17.2 | Attachment |  | No display for Attachment
ADMIN00 | Administrative Use Only |  |
ADMIN01 | Link ID prefix |  | cr
ADMIN02 | Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any |  | initiate-study-populate-exampleQR
ADMIN03 | ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any |  | ResearchStudyExample-sIRB
Documentation for this format