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 Medical Event Questionnaire Response

LinkId | Text | Definition | Answer
--- | --- | --- | ---
medical-ae-populate-exampleQR |  | QuestionnaireResponse |
mae1 | Research Study |  |
mae1.1 | Study Title |  | Study of Drug A for arthritis
mae1.2 | IRB Protocol Number |  | PRO098765
mae1.3 | Study Type |  | Temporary Codes INT: Interventional
mae1.4 | Does this protocol require an FDA exemption? |  | expandedYes-NoIndicator Y: Yes
mae1.5 | Is an IND or IDE being used in this study? |  | expandedYes-NoIndicator Y: Yes
mae4 | Organization/Site |  |
mae4.1 | Where Adverse Medical Event Occurred |  |
mae4.1.7 | Did the Adverse Medical Event occur at the lead principal investigator site? |  | expandedYes-NoIndicator N: No
ExternalDataFor_mae4.1.1 | External Data For linkId mae4.1.1 |  |
mae4.1.1 | If the Adverse Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the the relying institution and relying site principal investigator details below. |  | [not stated] : Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA
mae4.1.2 | Name of organization/site where the event occurred |  | Test Example University
mae4.7 | Site Principal Investigator |  |
mae4.7.1 | First Name |  | Xi-Yang
mae4.7.2 | Last Name |  | Lee
mae4.7.5 | Suffix |  | Jr.
mae4.7.6 | Degree(s) |  | MD, PhD
mae4.7.3 | Phone |  | 6781233456
mae4.7.4 | Email |  | XiYangLee@teu.med.edu
mae4.9 | Responsibility for Adverse Medical Event Reporting |  |
mae4.9.1 | If the Adverse Medical Event occurred at a relying site, will the lead principal investigator site be recording the Adverse Non-Medical Event? |  | expandedYes-NoIndicator Y: Yes
mae4.9.2 | Name of organization/site which is recording the Adverse Medical event |  | Sample University Medical Center
mae3 | Primary Contact |  |
mae3.1 | First Name |  | Jane
mae3.2 | Last Name |  | Doe
mae3.3 | Phone |  | 567-123-1234
mae3.4 | Email |  | drjanedoe@sampleuniversity.edu
mae5 | Participant Information |  |
mae5.1 | Patient ID |  | 12345
mae5.2 | Age |  | 58
mae5.3 | Birth Sex |  | administrativeSex M: Male
mae5.4 | Weight |  | 245 [lb]
mae5.5 | Height |  | 67 [in]
mae5.6 | Ethnicity |  | Ethnicity 2186-5: Not Hispanic or Latino
mae5.7 | Race |  | Race 2106-3: White
mae5.8 | Which Arm/Cohort/treatment group was the participant assigned to (if known)? |  | unknown
mae5.9 | Participant dosed or received study agent |  | expandedYes-NoIndicator NI: No Information
mae5.11 | Were there any Protocol Deviations/Violations/Exceptions for this participant? |  | expandedYes-NoIndicator N: No
mae6 | Adverse Medical Event Information |  |
mae6.1 | Submission Type |  | Temporary Codes INITIAL: Initial
mae6.2 | Start Date |  | 2021-11-05
mae6.3 | Reported Date |  | 2021-11-06
mae6.4 | Recorded Date |  | 2021-11-06
mae6.10 | Is the Adverse Medical Event Serious? |  | AdverseEventSeriousness serious: Serious
mae6.9 | Severity |  | AdverseEventSeverity mild: Mild
mae6.40 | Narrative of the Adverse Event: |  | Blood clot developed in right leg after several days of inactivity. Participant experienced swelling and pain.
mae6.5 | Medical Description of Adverse Event |  | Deep Vein Thrombosis
mae6.6 | Is the Adverse Medical event still ongoing? |  | expandedYes-NoIndicator N: No
mae6.7 | Stop Date |  | 2021-11-05
mae6.8 | Was the event expected? |  | eventExpected N: No
mae6.11 | Seriousness |  |
mae6.11.1 | Seriousness |  | Temporary Codes ResultsInHospitalization: Requires or prolongs inpatient hospitalization
mae6.12 | What is the date Adverse Medical Event became serious? |  | 2021-11-05
mae6.13 | Outcome of Adverse Medical Event |  | Temporary Codes RCVRED: recovered/resolved
mae6.15 | Relationship of Adverse Medical Event to Study Intervention |  | AdverseEventCausalityAssessment possible: Possible
mae6.16 | Rationale for relationship with study intervention |  | Patient was inactive for several days which might have been the cause.
mae6.23 | Action Taken |  |
mae6.23.1 | Action Taken Regarding Study Intervention |  | actionTakenInResponseToTheEvent WT: Product withdrawn temporarily
mae6.24 | If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate? |  | expandedYes-NoIndicator Y: Yes
mae6.25 | If study intervention was restarted (rechallenge) did AE recur? |  | expandedYes-NoIndicator N: No
mae6.50 | SAE Concomitant Medications, Treatments/Procedures and Tests |  |
mae6.50.26 | Did the participant receive any relevant concomitant medications in response to the SAE? |  | expandedYes-NoIndicator Y: Yes
mae6.50.28 | SAE Concomitant Medications |  |
mae6.50.28.1 | Medication Name |  | warfarin
mae6.50.28.2 | Indication |  | anticoagulant
mae6.50.28.3 | Start Date |  | 2021-11-05
mae6.50.28.4 | Stop Date |  | 2022-02-04
mae6.50.28.5 | Ongoing |  | expandedYes-NoIndicator N: No
mae6.50.29 | Did the participant receive any treatments/procedures in response to the SAE? |  | expandedYes-NoIndicator N: No
mae6.50.37 | Did the participant receive relevant laboratory or diagnostic tests in response to the SAE? |  | expandedYes-NoIndicator Y: Yes
mae6.50.38 | SAE Laboratory or Diagnostic Tests |  |
mae6.50.38.1 | Lab/Diagnostic Test |  | ultrasound
mae6.50.38.2 | Date |  | 2021-11-05
mae6.50.38.3 | Result |  | positive
mae6.50.38.6 | Comments |  | blood clot noted
mae11 | Optional Attachments |  |
mae11.1 | Describe the file that is being attached (optional) |  | Treatment instructions received from sponsor regarding this AE.
mae11.2 | Attachment |  | No display for Attachment
ADMIN00 | Administrative Use Only |  |
ADMIN01 | Link ID prefix |  | mae
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