Single Institutional Review Board (sIRB) Implementation Guide
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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 Adverse Medical Event Questionnaire Response

LinkIdTextDefinitionAnswerdoco
.. medical-ae-populate-exampleQRQuestionnaireResponse
... mae1Research Study
.... mae1.1Study TitleStudy of Drug A for arthritis
.... mae1.2IRB Protocol NumberPRO098765
.... mae1.3Study TypeTemporary Codes INT: Interventional
.... mae1.4Does this protocol require an FDA exemption?expandedYes-NoIndicator Y: Yes
.... mae1.5Is an IND or IDE being used in this study?expandedYes-NoIndicator Y: Yes
... mae4Organization/Site
.... mae4.1Where Adverse Medical Event Occurred
..... mae4.1.7Did the Adverse Medical Event occur at the lead principal investigator site?expandedYes-NoIndicator N: No
..... ExternalDataFor_mae4.1.1External Data For linkId mae4.1.1
..... mae4.1.1If 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
..... mae4.1.2Name of organization/site where the event occurredTest Example University
.... mae4.7Site Principal Investigator
..... mae4.7.1First NameXi-Yang
..... mae4.7.2Last NameLee
..... mae4.7.5SuffixJr.
..... mae4.7.6Degree(s)MD, PhD
..... mae4.7.3Phone6781233456
..... mae4.7.4EmailXiYangLee@teu.med.edu
.... mae4.9Responsibility for Adverse Medical Event Reporting
..... mae4.9.1If 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
..... mae4.9.2Name of organization/site which is recording the Adverse Medical eventSample University Medical Center
... mae3Primary Contact
.... mae3.1First NameJane
.... mae3.2Last NameDoe
.... mae3.3Phone567-123-1234
.... mae3.4Emaildrjanedoe@sampleuniversity.edu
... mae5Participant Information
.... mae5.1Patient ID12345
.... mae5.2Age58
.... mae5.3Birth SexadministrativeSex M: Male
.... mae5.4Weight245 [lb]
.... mae5.5Height67 [in]
.... mae5.6EthnicityEthnicity 2186-5: Not Hispanic or Latino
.... mae5.7RaceRace 2106-3: White
.... mae5.8Which Arm/Cohort/treatment group was the participant assigned to (if known)?unknown
.... mae5.9Participant dosed or received study agentexpandedYes-NoIndicator NI: No Information
.... mae5.11Were there any Protocol Deviations/Violations/Exceptions for this participant?expandedYes-NoIndicator N: No
... mae6Adverse Medical Event Information
.... mae6.1Submission TypeTemporary Codes INITIAL: Initial
.... mae6.2Start Date2021-11-05
.... mae6.3Reported Date2021-11-06
.... mae6.4Recorded Date2021-11-06
.... mae6.10Is the Adverse Medical Event Serious?AdverseEventSeriousness serious: Serious
.... mae6.9SeverityAdverseEventSeverity mild: Mild
.... mae6.40Narrative of the Adverse Event:Blood clot developed in right leg after several days of inactivity. Participant experienced swelling and pain.
.... mae6.5Medical Description of Adverse EventDeep Vein Thrombosis
.... mae6.6Is the Adverse Medical event still ongoing?expandedYes-NoIndicator N: No
.... mae6.7Stop Date2021-11-05
.... mae6.8Was the event expected?eventExpected N: No
.... mae6.11Seriousness
..... mae6.11.1SeriousnessTemporary Codes ResultsInHospitalization: Requires or prolongs inpatient hospitalization
.... mae6.12What is the date Adverse Medical Event became serious?2021-11-05
.... mae6.13Outcome of Adverse Medical EventTemporary Codes RCVRED: recovered/resolved
.... mae6.15Relationship of Adverse Medical Event to Study InterventionAdverseEventCausalityAssessment possible: Possible
.... mae6.16Rationale for relationship with study interventionPatient was inactive for several days which might have been the cause.
.... mae6.23Action Taken
..... mae6.23.1Action Taken Regarding Study InterventionactionTakenInResponseToTheEvent WT: Product withdrawn temporarily
.... mae6.24If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate?expandedYes-NoIndicator Y: Yes
.... mae6.25If study intervention was restarted (rechallenge) did AE recur?expandedYes-NoIndicator N: No
.... mae6.50SAE Concomitant Medications, Treatments/Procedures and Tests
..... mae6.50.26Did the participant receive any relevant concomitant medications in response to the SAE?expandedYes-NoIndicator Y: Yes
..... mae6.50.28SAE Concomitant Medications
...... mae6.50.28.1Medication Namewarfarin
...... mae6.50.28.2Indicationanticoagulant
...... mae6.50.28.3Start Date2021-11-05
...... mae6.50.28.4Stop Date2022-02-04
...... mae6.50.28.5OngoingexpandedYes-NoIndicator N: No
..... mae6.50.29Did the participant receive any treatments/procedures in response to the SAE?expandedYes-NoIndicator N: No
..... mae6.50.37Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?expandedYes-NoIndicator Y: Yes
..... mae6.50.38SAE Laboratory or Diagnostic Tests
...... mae6.50.38.1Lab/Diagnostic Testultrasound
...... mae6.50.38.2Date2021-11-05
...... mae6.50.38.3Resultpositive
...... mae6.50.38.6Commentsblood clot noted
... mae11Optional Attachments
.... mae11.1Describe the file that is being attached (optional)Treatment instructions received from sponsor regarding this AE.
.... mae11.2AttachmentNo display for Attachment
... ADMIN00Administrative Use Only
.... ADMIN01Link ID prefixmae
.... 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 ResponsesResearchStudyExample-sIRB

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