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 Adverse Non-Medical Event Questionnaire Response

LinkId | Text | Definition | Answer
--- | --- | --- | ---
nme-populate-exampleQR |  | QuestionnaireResponse |
nme1 | Research Study |  |
nme1.1 | Study Title |  | Study of Drug A for arthritis
nme1.3 | IRB Protocol Number |  | PRO098765
nme1.4 | Status |  | Temporary Codes nochange: No change in research activities
nme7 | Organization/Site |  |
nme7.1 | Where Adverse Non-Medical Event Occurred |  |
nme7.1.8 | Did the Adverse Non-Medical Event occur at the lead principal investigator site? |  | expandedYes-NoIndicator N: No
nme7.1.11 | Did the Adverse Non-Medical Event occur at one of the relying sites? |  | expandedYes-NoIndicator Y: Yes
ExternalDataFor_nme7.1.9 | External Data For linkId nme7.1.9 |  |
nme7.1.9 | If the Adverse Non-Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the relying institution and relying site principal investigator details below. |  | [not stated] : Central Campus Test University | | Maria Smith, PhD | Central, MI
nme7.1.1 | Name of organization/site where the Adverse Non-Medical Event occurred |  | Central Campus Test University
nme7.1.2 | City |  | Central
nme7.1.3 | State |  | MI
nme7.1.4 | Country |  | United States
nme7.2 | Responsibility for Adverse Non-Medical Event Reporting |  |
nme7.2.8 | If the Adverse Non-Medical Event occurred at a relying site or at another organization (unrelated to the lead principal investigator organization/site or relying sites), will the lead principal investigator site be recording the Adverse Non-Medical Event? |  | expandedYes-NoIndicator Y: Yes
nme7.2.1 | Name of organization/site which is recording the Adverse Non-Medical Event |  | Sample University Medical Center
nme7.2.2 | City |  | Sample City
nme7.2.3 | State |  | NC
nme7.2.4 | Country |  | United States
nme8 | Site Principal Investigator for the site where Adverse Non-Medical Event occurred |  |
nme8.1 | First Name |  | Maria
nme8.4 | Last Name |  | Smith
nme8.6 | Degree(s) |  | PhD
nme8.2 | Phone |  | 8901231234
nme8.3 | Email |  | maria.smith@CCTU.med.edu
nme3 | Report |  |
nme3.1 | Report Date |  | 2022-02-27
nme3.2 | Report Status |  | Temporary Codes init: Initial
nme3.3 | Select at least one of the following criteria: |  |
nme3.3.4 | New information resulted in unexpected change in risks of the research |  | true
nme3.3.5 | New or increased risk |  |
nme3.3.5.1 | Date: |  | 2022-02-27
nme3.3.5.2 | Date discovered: |  | 2022-02-26
nme3.3.5.3 | Description: |  | [answer]
nme3.3.6 | Unanticipated Problem Involving Risk to Participants or Others |  | true
nme3.3.7 | Unanticipated Problem |  |
nme3.3.7.1 | Event date: |  | 2022-02-26
nme3.3.7.2 | Date event became aware to study team: |  | 2022-02-27
nme3.3.7.3 | Event Summary: |  | [answer]
nme3.3.7.4 | Was this event Unexpected? |  | expandedYes-NoIndicator Y: Yes
nme3.3.7.5 | If yes, please explain: |  | [answer]
nme3.3.7.6 | Was this event Related or Possibly Related to participation in the research? |  | expandedYes-NoIndicator Y: Yes
nme3.3.7.7 | If yes, please explain: |  | [answer]
nme3.3.7.8 | Does this event suggest that the research places participant(s) or others at a greater Risk of harm than was previously known? |  | expandedYes-NoIndicator Y: Yes
nme3.3.7.9 | If yes, please explain: |  | [answer]
nme3.3.10 | A breach of Confidentiality |  | false
nme3.3.14 | Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team |  | true
nme3.3.15 | Participant Complaint |  |
nme3.3.15.1 | Complaint Date: |  | 2022-02-27
nme3.3.15.2 | Date received: |  | 2022-02-27
nme3.3.15.3 | Description: |  | [answer]
nme4 | Reporting |  |
nme4.1 | Was the Sponsor notified? |  | expandedYes-NoIndicator Y: Yes
nme4.2 | Notification date: |  | 2022-02-27
nme4.3 | Was the IRB notified? |  | expandedYes-NoIndicator Y: Yes
nme4.4 | Notification date: |  | 2022-02-27
nme4.5 | Were any Other Parties notified? |  | expandedYes-NoIndicator Y: Yes
nme4.6 | List other notified parties |  | [answer]
nme5 | Corrective and Preventative Action Plan |  |
nme5.1 | Was a Root Cause analysis performed? |  | Temporary Codes pending: Pending - Currently under development
nme5.2b | If pending, describe status and interim findings, if any: |  | [answer]
nme5.3 | Was Corrective Action implemented? |  | Temporary Codes pending: Pending - Currently under development
nme5.4 | If Corrective Action was implemented or is pending, provide a summary: |  | [answer]
nme5.5 | Was Preventitive Action implemented? |  | Temporary Codes completed: Done, performed or completed
nme5.6 | If Preventitive Action was implemented or is pending, provide a summary: |  | [answer]
nme6 | Study Protocol and Informed Consent |  |
nme6.1a | Are changes required to the Study Protocol as a result of this report? |  | expandedYes-NoIndicator Y: Yes
nme6.3a | Are changes required to the Informed Consent as a result of this report? |  | expandedYes-NoIndicator Y: Yes
nme6.5 | Are notifications or re-consenting of participants required as a result of changes in Study Protocol or Informed Consent? |  | expandedYes-NoIndicator Y: Yes
nme6.6 | If yes, detail how the notification and/or re-consent will occur: |  | [answer]
nme11 | Optional Attachments |  |
nme11.1 | Describe the file that is being attached (optional) |  | [answer]
nme11.2 | Attachment |  | No display for Attachment
ADMIN00 | Administrative Use Only |  |
ADMIN01 | Link ID prefix |  | nme
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 |  | ResearchStudyExample-sIRB
Documentation for this format