Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot

This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

Example Questionnaire: Adverse Medical Event Questionnaire

The Adverse Events Questionnaire is intended to create a Medical Adverse Event Report to the sIRB to notify them of the Medical Adverse Event, the medical description of the event, the resolution of the event, whether there were associated protocol violations and the relationship of the medical event to the study agent.

Structure
LinkIdTextCardinalityTypeFlagsDescription & Constraintsdoco
.. AE_QuestionnaireQuestionnaire
... mae1RESEARCH STUDY0..1group
.... mae1.1Study Title0..1string
..... mae1.1_helpStudy Title from the Informed Consent0..1display
.... mae1.2IRB Protocol Number0..1string
..... mae1.2_helpNumber assigned to the protocol by IRB0..1display
.... mae1.3Study Type0..1choiceOptions: 2 options
..... mae1.3_helpSelect the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)0..1display
.... mae1.4Does this protocol require an FDA exemption?0..1choiceOptions: 2 options
..... mae1.4_helpIndicator for use of FDA regulated product0..1display
.... mae1.5Is an IND or IDE being used in this study?0..1choiceOptions: 2 options
..... mae1.5_helpIs an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?0..1display
.... mae1.6IND/IDE Number0..1stringEnable When:
... mae2Site Principal Investigator0..1group
.... mae2.1First Name0..1string
..... mae2.1_helpFirst or given name associated with the site principal investigator0..1display
.... mae2.2Last Name0..1string
..... mae2.2_helpSurname or family name associated with the site principal investigator0..1display
.... mae2.5Suffix0..1string
..... mae2.5_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the site principal investigator's name0..1display
.... mae2.6Degree(s)0..1string
..... mae2.6_helpProfessional and Academic degrees associated with the site investigator0..1display
.... mae2.3Phone0..1string
.... mae2.4Email0..1string
... mae3Primary Contact0..1group
.... mae3_helpPersonnel completing the adverse event documentation at the relying site0..1display
.... mae3.1First Name0..1string
.... mae3.2Last Name0..1string
.... mae3.3Phone0..1string
.... mae3.4Email0..1string
... mae4Site/Organization0..1group
.... mae4_helpLocation where adverse event is recorded0..1display
.... mae4.1Name of organization/site where the event occurred0..1string
.... mae4.2Name of organization/site which is recording the Adverse Medical event0..1string
... mae5Participant Information0..1group
.... mae5.1Patient ID0..1string
..... mae5.1_helpParticipant identifier from study case report form0..1display
.... mae5.2Age0..1string
.... mae5.3Birth Sex0..1choiceOptions: 4 options
.... mae5.4Weight0..1quantity
.... mae5.5Height0..1quantity
.... mae5.6Ethnicity0..1choiceOptions: 2 options
.... mae5.7Race0..*choiceOptions: 5 options
.... mae5.8Which Arm/Cohort/treatment group was the participant assigned to (if known)?0..1string
..... mae5.8_helpPatient's treatment strategy assignment, if known.0..1display
.... mae5.9Participant dosed or received study agent0..1choiceOptions: 4 options
..... mae5.9_helpDid the participant receive the investigational agent? If answer is unknown due to blinding, select No Information.0..1display
.... mae5.10What study agent was received:0..1choiceEnable When:
Options: 3 options
..... mae5.10_helpinvestigational agent or placebo or blinded study0..1display
.... mae5.11Were there any Protocol Deviations/Violations/Exceptions for this participant?0..1choiceOptions: 2 options
..... mae5.11_helpIndicator if adverse medical event occurred with protocol deviation, violation, exception0..1display
.... mae5.12Describe the Protocol Deviations/Violations/Exceptions0..1textEnable When:
..... mae5.12_helpDescription of protocol deviations, violations, or exceptions that occurred for this participant0..1display
... mae6Adverse Medical Event Information0..1group
.... mae6.1Submission Type0..1choiceOptions: 2 options
..... mae6.1_helpType of adverse event report being submitted0..1display
.... mae6.2Start Date0..1date
..... mae6.2_helpDate adverse event started0..1display
.... mae6.3Reported Date0..1date
..... mae6.3_helpDate of this report0..1display
.... mae6.4Recorded Date0..1date
..... mae6.4_helpDate this adverse event was first recorded0..1display
.... mae6.5aNarrative of the Adverse Event:0..1text
..... mae6.5a_helpProvide a discussion of the Adverse Event. If a Serious Medical Event, narrative must provide a description of the SAE including chronological clinical presentation and evolution of the SAE and associated signs/symptoms). Serious Medical Event criteria are defined in the protocol.0..1display
.... mae6.5bMedical Description of Adverse Event0..1text
..... mae6.5b_helpDiagnosis associated with adverse event. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.0..1display
.... mae6.6Is the Adverse Medical event still ongoing?0..1choiceOptions: 2 options
..... mae6.6_helpIndicator if adverse event is still continuing0..1display
.... mae6.7Stop Date0..1dateEnable When:
..... mae6.7_helpDate that the event resolved0..1display
.... mae6.8Was the event expected?0..1choiceOptions: 2 options
..... mae6.8_helpAdverse event was expected or not0..1display
.... mae6.9Severity0..1choiceOptions: 3 options
..... mae6.9_helpPhysician assessment using sponsor defined categories0..1display
.... mae6.10Is the Adverse Medical Event Serious?0..1choiceOptions: 2 options
..... mae6.10_helpIndicator if an undesirable experience is associated with use of a medical product0..1display
.... mae6.11Seriousness0..1choiceEnable When:
Options: 9 options
..... mae6.11_helpSerious criteria are defined in the protocol0..1display
.... mae6.11bOther-specify0..1textEnable When:
..... mae6.11b_helpDescribe other serious consequences or other medically important condition0..1display
.... mae6.12What is the date Adverse Medical Event became serious?0..1dateEnable When:
..... mae6.12_helpDate adverse event qualified as serious0..1display
.... mae6.13Outcome of Adverse Medical Event0..1choiceOptions: 7 options
..... mae6.13_helpParticipant's status after the adverse event0..1display
.... mae6.14Was autopsy performed?0..1choiceEnable When:
Options: 3 options
..... mae6.14_helpIndicator if participant was autopsied0..1display
.... mae6.15Relationship of Adverse Medical Event to Study Intervention0..1choiceOptions: 5 options
.... mae6.16Rationale for relationship with study intervention0..1textEnable When:
..... mae6.16_helpExplanation for relationship between study intervention and adverse event0..1display
.... mae6.17What are possible alternate causes of the SAE?0..1choiceEnable When:
Options: 6 options
..... mae6.17_helpReason for possible alternative serious adverse event causes0..1display
.... mae6.18Study Procedure-specify0..1textEnable When:
..... mae6.18_helpStudy procedure associated with SAE0..1display
.... mae6.19Pre-existing condition-specify0..1textEnable When:
..... mae6.19_helpPre-existing condition associated with SAE0..1display
.... mae6.20Underlying disease-specify0..1textEnable When:
..... mae6.20_helpUnderlying disease associated with SAE0..1display
.... mae6.21Concomittant medication-specify0..1textEnable When:
..... mae6.21_helpConcomitant medication associated with SAE0..1display
.... mae6.22Other known or suspected cause-specify0..1textEnable When:
..... mae6.22_helpOther causal reason was associated with SAE0..1display
.... mae6.23Action Taken Regarding Study Intervention0..1choiceOptions: 6 options
..... mae6.23_helpChanges to study intervention made after adverse event was detected0..1display
.... mae6.23bOther-specify0..1textEnable When:
..... mae6.23b_helpDescribe other changes to intervention made after adverse event was detected0..1display
.... mae6.24If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did AE diminish/abate?0..1choiceOptions: 3 options
..... mae6.24_helpAdverse event diminished/abated after study intervention was discontinued, interrupted, or dose reduced (dechallenged)0..1display
.... mae6.25If study intervention was restarted (rechallenge) did AE recur?0..1choiceOptions: 3 options
..... mae6.25_helpAdverse event recurred when the study intervention was restarted0..1display
.... mae6.26Did the participant receive any relevant concomitant medications in response to the SAE?0..1choiceEnable When:
Options: 2 options
.... mae6.27SAE Concomitant Medications0..*groupEnable When:
..... mae6.27_helpConcomitant medication associated with SAE0..1display
..... mae6.28.1Medication Name0..1string
...... mae6.28.1_helpName of concomitant medication given to participant in response to SAE0..1display
..... mae6.28.2Indication0..1string
...... mae6.28.2_helpIndication for giving the concomitant medication to participant0..1display
..... mae6.28.3Start Date0..1date
...... mae6.28.3_helpStart date for the concomitant medication given to participant0..1display
..... mae6.28.4Stop Date0..1date
...... mae6.28.4_helpStop date for the concomitant medication given to the participant0..1display
..... mae6.28.5Ongoing0..1choiceOptions: 2 options
...... mae6.28.5_helpIs concomitant medication administration for participant ongoing?0..1display
.... mae6.29Did the participant receive any treatments/procedures in response to the SAE?0..1open-choiceEnable When:
Options: 2 options
..... mae6.29_helpTreatments/procedures administered in response to SAE0..1display
.... mae6.30SAE Treatments/Procedures0..*groupEnable When:
..... mae6.30_helpName of SAE treatment/procedure participant received0..1display
..... mae6.30.1Treatment/Procedure0..1string
...... mae6.30.1_helpName of SAE treatment/procedure participant received0..1display
..... mae6.30.2Start Date0..1date
...... mae6.30.2_helpStart date for SAE treatment/procedure participant received0..1display
..... mae6.30.3Stop Date0..1date
...... mae6.30.3_helpStop date for SAE treatment/procedure participant received0..1display
..... mae6.30.4Ongoing0..1choiceOptions: 2 options
...... mae6.30.4_helpIs the SAE treatment/procedure for the participant ongoing0..1display
... mae7Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?0..1open-choiceEnable When:
Options: 2 options
.... mae7_helpWere any laboratory or diagnostic tests administered to the participant in response to the SAE?0..1display
... mae8SAE Laboratory or Diagnostic Tests0..*groupEnable When:
.... mae8_helpLaboratory or diagnostic tests obtained in response to AE0..1display
.... mae8.1Lab/Diagnostic Test0..1string
.... mae8.2Date0..1date
.... mae8.3Result0..1string
.... mae8.4Low Range0..1string
.... mae8.5High Range0..1string
.... mae8.6Comments0..1string
... ADMIN00Administrative Use Only0..1group
.... ADMIN01Link ID prefix0..1stringInitial Value: string = mae
.... ADMIN02Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any0..1stringInitial Value: string = temporarily unavailable
.... ADMIN03ID of the Research Study FHIR Resource associated with the study Questionnaire Responses0..1stringInitial Value: string = temporarily unavailable
.... ADMIN04Questionnaire Response ID of the local considerations Questionnaire Response, if any0..1string

doco Documentation for this format

Option Sets

Answer options for mae1.3

Answer options for mae1.4

Answer options for mae1.5

Answer options for mae5.3

Answer options for mae5.6

Answer options for mae5.7

Answer options for mae5.9

Answer options for mae5.10

Answer options for mae5.11

Answer options for mae6.1

Answer options for mae6.6

Answer options for mae6.8

Answer options for mae6.9

Answer options for mae6.10

Answer options for mae6.11

Answer options for mae6.13

Answer options for mae6.14

Answer options for mae6.15

Answer options for mae6.17

Answer options for mae6.23

Answer options for mae6.24

Answer options for mae6.25

Answer options for mae6.26

Answer options for mae6.28.5

Answer options for mae6.29

Answer options for mae6.30.4

Answer options for mae7