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 Non-Medical Event Questionnaire Response

LinkIdTextDefinitionAnswerdoco
.. nme-populate-exampleQRQuestionnaireResponse
... nme1Research Study
.... nme1.1Study TitleStudy of Drug A for arthritis
.... nme1.3IRB Protocol NumberPRO098765
.... nme1.4StatusTemporary Codes nochange: No change in research activities
... nme7Organization/Site
.... nme7.1Where Adverse Non-Medical Event Occurred
..... nme7.1.8Did the Adverse Non-Medical Event occur at the lead principal investigator site?expandedYes-NoIndicator N: No
..... nme7.1.11Did the Adverse Non-Medical Event occur at one of the relying sites?expandedYes-NoIndicator Y: Yes
..... ExternalDataFor_nme7.1.9External Data For linkId nme7.1.9
..... nme7.1.9If 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
..... nme7.1.1Name of organization/site where the Adverse Non-Medical Event occurredCentral Campus Test University
..... nme7.1.2CityCentral
..... nme7.1.3StateMI
..... nme7.1.4CountryUnited States
.... nme7.2Responsibility for Adverse Non-Medical Event Reporting
..... nme7.2.8If 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
..... nme7.2.1Name of organization/site which is recording the Adverse Non-Medical EventSample University Medical Center
..... nme7.2.2CitySample City
..... nme7.2.3StateNC
..... nme7.2.4CountryUnited States
... nme8Site Principal Investigator for the site where Adverse Non-Medical Event occurred
.... nme8.1First NameMaria
.... nme8.4Last NameSmith
.... nme8.6Degree(s)PhD
.... nme8.2Phone8901231234
.... nme8.3Emailmaria.smith@CCTU.med.edu
... nme3Report
.... nme3.1Report Date2022-02-27
.... nme3.2Report StatusTemporary Codes init: Initial
.... nme3.3Select at least one of the following criteria:
..... nme3.3.4New information resulted in unexpected change in risks of the researchtrue
..... nme3.3.5New or increased risk
...... nme3.3.5.1Date:2022-02-27
...... nme3.3.5.2Date discovered:2022-02-26
...... nme3.3.5.3Description:[answer]
..... nme3.3.6Unanticipated Problem Involving Risk to Participants or Otherstrue
..... nme3.3.7Unanticipated Problem
...... nme3.3.7.1Event date:2022-02-26
...... nme3.3.7.2Date event became aware to study team:2022-02-27
...... nme3.3.7.3Event Summary:[answer]
...... nme3.3.7.4Was this event Unexpected?expandedYes-NoIndicator Y: Yes
...... nme3.3.7.5If yes, please explain:[answer]
...... nme3.3.7.6Was this event Related or Possibly Related to participation in the research?expandedYes-NoIndicator Y: Yes
...... nme3.3.7.7If yes, please explain:[answer]
...... nme3.3.7.8Does 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
...... nme3.3.7.9If yes, please explain:[answer]
..... nme3.3.10A breach of Confidentialityfalse
..... nme3.3.14Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by teamtrue
..... nme3.3.15Participant Complaint
...... nme3.3.15.1Complaint Date:2022-02-27
...... nme3.3.15.2Date received:2022-02-27
...... nme3.3.15.3Description:[answer]
... nme4Reporting
.... nme4.1Was the Sponsor notified?expandedYes-NoIndicator Y: Yes
.... nme4.2Notification date:2022-02-27
.... nme4.3Was the IRB notified?expandedYes-NoIndicator Y: Yes
.... nme4.4Notification date:2022-02-27
.... nme4.5Were any Other Parties notified?expandedYes-NoIndicator Y: Yes
.... nme4.6List other notified parties[answer]
... nme5Corrective and Preventative Action Plan
.... nme5.1Was a Root Cause analysis performed?Temporary Codes pending: Pending - Currently under development
.... nme5.2bIf pending, describe status and interim findings, if any:[answer]
.... nme5.3Was Corrective Action implemented?Temporary Codes pending: Pending - Currently under development
.... nme5.4If Corrective Action was implemented or is pending, provide a summary:[answer]
.... nme5.5Was Preventitive Action implemented?Temporary Codes completed: Done, performed or completed
.... nme5.6If Preventitive Action was implemented or is pending, provide a summary:[answer]
... nme6Study Protocol and Informed Consent
.... nme6.1aAre changes required to the Study Protocol as a result of this report?expandedYes-NoIndicator Y: Yes
.... nme6.3aAre changes required to the Informed Consent as a result of this report?expandedYes-NoIndicator Y: Yes
.... nme6.5Are notifications or re-consenting of participants required as a result of changes in Study Protocol or Informed Consent?expandedYes-NoIndicator Y: Yes
.... nme6.6If yes, detail how the notification and/or re-consent will occur:[answer]
... nme11Optional Attachments
.... nme11.1Describe the file that is being attached (optional)[answer]
.... nme11.2AttachmentNo display for Attachment
... ADMIN00Administrative Use Only
.... ADMIN01Link ID prefixnme
.... 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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