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 Non-Medical Event Questionnaire

The Non-Medical Adverse Questionnaire is intended to create a Non-Medical Adverse Event Report to the sIRB. An example of a Non-Medical Adverse Event is the inadvertent disclosure to several participants that they are receiving the placebo in a blind study. The Non-Medical Adverse Questionnaire captures details for the report such as the root cause of the event, the corrective action plan and associated changes to the protocol or consent form as a result of the event.

Structure
LinkIdTextCardinalityTypeFlagsDescription & Constraintsdoco
.. NonMedical_eventsQuestionnaire
... nme1Research Study0..1group
.... nme1.1Study Title:0..1string
..... nme1.1_helpStudy Title from the Informed Consent0..1display
.... nme1.3IRB Protocol Number:0..1string
..... nme1.3_helpIRB Number from the Informed Consent0..1display
.... nme1.4Status:0..1choiceOptions: 4 options
..... nme1.4_helpStatus of study research activities0..1display
.... nme1.5If partial, please explain:0..1textEnable When:
..... nme1.5_helpExplanation for voluntary hold on new participant enrollment.0..1display
... nme2aSite/Organization0..1group
.... nme2a_helpLocation of Adverse Non-Medical Event0..1display
.... nme2a.1Organization/site where the Adverse Non-Medical Event occurred0..1group
..... nme2a.1.1Name of organization/site where the Adverse Non-Medical Event occurred0..1string
..... nme2a.1.2City0..1string
..... nme2a.1.3State0..1string
..... nme2a.1.4Country0..1string
.... nme2a.2Organization/site which is recording the Adverse Non-Medical Event0..1group
..... nme2a.2.1Name of organization/site which is recording the Adverse Non-Medical Event0..1string
..... nme2a.2.2City0..1string
..... nme2a.2.3State0..1string
..... nme2a.2.4Country0..1string
... nme2bSite Principal Investigator for the site where Adverse Non-Medical Event occurred0..1group
.... nme2b_helpSite Principal Investigator responsible for the research study at the site where Adverse Non-Medical Event occurred0..1display
.... nme2b.1First Name0..1string
..... nme2b.1_helpFirst or given name associated with the site PI0..1display
.... nme2b.4Last Name0..1string
..... nme2b.4_helpSurname or family name associated with the principal investigator0..1display
.... nme2b.5Suffix0..1string
..... nme2b.5_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the principal investigator's name0..1display
.... nme2b.6Degree(s)0..1string
..... nme2b.6_helpProfessional and Academic degrees associated with the principal investigator0..1display
.... nme2b.2Phone:0..1string
..... nme2b.2_helpPhone number for site PI0..1display
.... nme2b.3Email:0..1string
..... nme2b.3_helpEmail address for site PI0..1display
... nme3Report0..1group
.... nme3_helpNon-medical adverse event report0..1display
.... nme3.1Report Date:0..1date
..... nme3.1_helpDate report is created0..1display
.... nme3.2Report Status0..1choiceOptions: 2 options
..... nme3.2_helpIndicator if report is the Initial report or follow-up report0..1display
.... nme3.3Check at least one of the following criteria:0..1group
..... nme3.3_helpReason for uanticipated problem reporting0..1display
.... nme3.4New information resulted in unexpected change in risks of the research.0..1boolean
..... nme3.4_helpIndicator if new information resulted in unexpected change in risks of research0..1display
.... nme3.5New or increased risk0..1groupEnable When:
..... nme3.5.1Date:0..1date
...... nme3.5.1_helpDate new or increased risk first documented0..1display
..... nme3.5.2Date discovered:0..1date
...... nme3.5.2_helpDate new or increased risk discovered0..1display
..... nme3.5.3Description:0..1text
...... nme3.5.3_helpDescription of new or increased risk0..1display
.... nme3.6Unanticipated Problem Involving Risk to Participants or Others0..1boolean
..... nme3.6_helpIndicator if problem Involved risk to participants or others0..1display
.... nme3.7Unanticipated Problem0..1groupEnable When:
..... nme3.7.1Event date:0..1date
...... nme3.7.1_helpDate event occurred0..1display
..... nme3.7.2Date event became aware to study team:0..1date
...... nme3.7.2_helpDate site research team first became aware of unanticipated problem0..1display
..... nme3.7.3Event Summary:0..1text
...... nme3.7.3_helpSummary description of unanticipated problem0..1display
..... nme3.7.4Was this event Unexpected?0..1choiceOptions: 2 options
...... nme3.7.4_helpIndicator if unanticipated problem was unexpected0..1display
..... nme3.7.5If yes, please explain:0..1textEnable When:
...... nme3.7.5_helpExplanation for why unanticipated problem was unexpected0..1display
..... nme3.7.6Was this event Related or Possibly Related to participation in the research?0..1choiceOptions: 2 options
...... nme3.7.6_helpUnanticipated problem associated with participation in the research study0..1display
..... nme3.7.7If yes, please explain:0..1textEnable When:
...... nme3.7.7_helpExplanation for why unanticipated problem is associated with participation in this research0..1display
..... nme3.7.8Does this event suggest that the research places participant(s) or others at a greater Risk of harm than was previously known?0..1choiceOptions: 2 options
...... nme3.7.8_helpIndicator if unanticipated problem increased risk of harm to participants0..1display
..... nme3.7.9If yes, please explain:0..1textEnable When:
...... nme3.7.9_helpExplanation for why unanticipated problem is associated with increased risk of harm for research participants0..1display
.... nme3.8Protocol Deviation (accidental or unintentional)0..1boolean
..... nme3.8_helpIndicator protocol deviation was accidental or unintentional0..1display
.... nme3.9Protocol Deviation (Non-Compliance)0..1groupEnable When:
..... nme3.9.1Date:0..1date
...... nme3.9.1_helpDate non-compliance first identified0..1display
..... nme3.9.2Date discovered:0..1date
...... nme3.9.2_helpDate site research team first discovered non-compliance protocol deviation0..1display
..... nme3.9.3Description:0..1text
...... nme3.9.3_helpDescription of non-compliance protocol deviation0..1display
..... nme3.9.4Does the deviation involve any of the following? (Check all that apply)0..1group
...... nme3.9.4_helpReason for protocol deviation0..1display
...... nme3.9.4.1Failure to obtain informed consent when IRB deemed required0..1boolean
....... nme3.9.4.1_helpInformed consent not obtained when required by IRB0..1display
...... nme3.9.4.2Modifying the protocol without IRB approval, except to avoid hazard to participants0..1boolean
....... nme3.9.4.2_helpProtocol modified without IRB approval0..1display
...... nme3.9.4.3Conducting research prior to IRB approval, during an IRB suspension or after IRB approval ends0..1boolean
....... nme3.9.4.3_helpConducting research without IRB approval0..1display
...... nme3.9.4.4Please explain any Checked items:0..1textEnable When:
....... nme3.9.9.4_helpExplanation for why protocol deviation category checked0..1display
..... nme3.9.5Was the deviation a substantive change from the protocol adversely affecting any of the following? (Check all that apply)0..1group
...... nme3.9.5.1The rights, welfare, or safety of the participants0..1boolean
...... nme3.9.5.2The integrity of the research area0..1boolean
...... nme3.9.5.3The participants' willingness to continue participation0..1boolean
...... nme3.9.5.4Please explain any Checked items:0..1textEnable When:
.... nme3.10A breach of Confidentiality0..1boolean
..... nme3.10_helpIndicator of breach of confidentiality0..1display
.... nme3.11Breach of Confidentiality0..1groupEnable When:
..... nme3.11.1Date breach occurred0..1date
...... nme3.11.1_helpDate breach of confidentiality first documented0..1display
..... nme3.11.2Date discovered:0..1date
...... nme3.11.2_helpDate site study team discovered breach of confidentiality0..1display
..... nme3.11.3Description:0..1text
...... nme3.11.3_helpBreach of confidentiality description0..1display
..... nme3.11_helpIndicator of breach of confidentiality0..1display
.... nme3.12Incarceration of a participant in a protocol not approved to enroll prisoners0..1boolean
..... nme3.12_helpIndicator of a study participant incarcerated when the protocol is not approved for prisoner enrollment0..1display
.... nme3.13Incarceration0..1groupEnable When:
..... nme3.13.1Date:0..1date
...... nme3.13.1_helpDate site first documented participant incarceration.0..1display
..... nme3.13.2Date incarceration was discovered:0..1date
...... nme3.13.2_helpData site study team discovered patient incarceration0..1display
..... nme3.13.3Description:0..1text
...... nme3.13.3_helpDescription of patient incarceration0..1display
.... nme3.14Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team.0..1boolean
..... nme3.14_helpIndicator if participant complaint of unexpected risks was not resolved by study team. Complaint information is related to study site.0..1display
.... nme3.15Participant Complaint0..1groupEnable When:
..... nme3.15.1Complaint Date:0..1date
...... nme3.15.1_helpDate site first documented participant unexpected risk complaint0..1display
..... nme3.15.2Date received:0..1date
...... nme3.15.2_helpDate site personnel first received participant unexpected risk complaint0..1display
..... nme3.15.3Description:0..1text
...... nme3.15.3_helpDescription of participant unexpected risk complaint0..1display
.... nme3.16Other Type of Adverse Non-Medical Event0..1boolean
..... nme3.16_helpIndicator for other type of Adverse Non-Medical Event0..1display
.... nme3.17Other Type0..1groupEnable When:
..... nme3.17.1Event date:0..1date
...... nme3.17.1_helpDate event occurred0..1display
..... nme3.17.2Date study team became aware of event:0..1date
...... nme3.17.2_helpDate site research team first became aware of the event0..1display
..... nme3.17.3Event Summary:0..1text
...... nme3.17.3_helpSummary description of the event0..1display
..... nme3.17.4Was this Adverse Non-Medical Event Unexpected?0..1choiceOptions: 2 options
...... nme3.17.4_helpIndicator if event was unexpected0..1display
..... nme3.17.5If yes, please explain:0..1textEnable When:
...... nme3.17.5_helpExplanation for why event was unexpected0..1display
..... nme3.17.6Was this event Related or Possibly Related to participation in the research?0..1choiceOptions: 2 options
...... nme3.17.6_helpAdverse Non-Medical Event association with participation in the research study0..1display
..... nme3.17.7If yes, please explain:0..1textEnable When:
...... nme3.17.7_helpExplanation for why the event is associated with participation in this research0..1display
... nme4Reporting0..1group
.... nme4_helpReporting information to Sponsor and both relying and reviewing IRBs0..1display
.... nme4.1Was the Sponsor notified?0..1choiceOptions: 2 options
..... nme4.1_helpIndicator if Sponsor was notified of non-medical adverse event0..1display
.... nme4.2Notification date:0..1dateEnable When:
..... nme4.2_helpDate sponsor notified of non-medical adverse event0..1display
.... nme4.3Was the IRB notified?0..1choiceOptions: 2 options
..... nme4.3_helpIndicator if study site IRB notified of non-medical adverse event0..1display
.... nme4.4Notification date:0..1dateEnable When:
..... nme4.4_helpDate study site IRB notified of non-medical adverse event0..1display
.... nme4.5Were any Other Parties notified?0..1choiceOptions: 2 options
..... nme4.5_helpOther parties notified of non-medical adverse event (such as coordinating center, other study sites, FDA)0..1display
.... nme4.6Please list other notified parties0..1textEnable When:
... nme5Corrective and Preventative Action Plan0..1group
.... nme5_helpDescription of corrective and preventative action plan0..1display
.... nme5.1Was a Root Cause analysis performed?0..1choiceOptions: 3 options
..... nme5.1_helpIndicataor if analysis of underlying causes or problems that led to the non-medical adverse event was performed0..1display
.... nme5.2aIf yes, provide determination:0..1textEnable When:
..... nme5.2a_helpDescription of what the root cause analysis determined the adverse event was caused by0..1display
.... nme5.2bIf pending, describe status and interim findings, if any:0..1textEnable When:
..... nme5.2b_helpDescribe status and any interim findings of the root cause analysis0..1display
.... nme5.3Was Corrective Action implemented?0..1choiceOptions: 3 options
..... nme5.3_helpIndicator if corrective action is implemented for non-medical adverse event0..1display
.... nme5.4If Corrective Action was implemented or is pending, provide a summary:0..1textEnable When:
..... nme5.4_helpSummary of corrective action implemented for non-medical adverse event. If still pending, provide a status of the corrective action plan0..1display
.... nme5.5Was Preventitive Action implemented?0..1choiceOptions: 3 options
..... nme5.5_helpIndicator if preventative action for non-medical adverse event is implemented0..1display
.... nme5.6If Preventitive Action was implemented or is pending, provide a summary:0..1textEnable When:
..... nme5.6_helpSummary of preventative action implemented for non-medical adverse event. If still pending, provide status.0..1display
... nme6Study Protocol and Informed Consent0..1group
.... nme6_helpDescription of protocol and informed consent changes0..1display
.... nme6.1aAre changes required to the Study Protocol as a result of this report?0..1choiceOptions: 2 options
..... nme6.1a_helpIndicator if changes are required in study protocol resulting from the non-medical adverse event report0..1display
.... nme6.1bReason(s) why changes are not required in the Study Protocol:0..1choiceEnable When:
Options: 3 options
.... nme6.2Justify your decision to not change the study protocol:0..1textEnable When:
..... nme6.2_helpJustification for decision not to change study protocol based upon non-medical adverse event report0..1display
.... nme6.3aAre changes required to the Informed Consent as a result of this report?0..1choiceOptions: 2 options
..... nme6.3a_helpIndicator if changes are required to the informed consent as a result of the non-medical adverse event report0..1display
.... nme6.3bReason(s) why changes are not required in the Informed Consent:0..1choiceEnable When:
Options: 3 options
.... nme6.4Justify your decision to not change the Informed Consent:0..1textEnable When:
..... nme6.4_helpJustification for decision not to change informed consent based upon non-medical adverse event report0..1display
.... nme6.5Are notifications or re-consenting of participants required as a result of this change?0..1choiceEnable When:
Options: 2 options
..... nme6.5_helpIndicator if notification or reconsenting of participants is required due to changes in Study Protocol or Informed Consent0..1display
.... nme6.6If yes, detail how the notification and/or re-consent will occur:0..1textEnable When:
..... nme6.6_helpDescription of how notification or re-consent will occur0..1display
.... nme6.7If no, justify your decision to not notify (re-consent) participants:0..1textEnable When:
..... nme6.7_helpRationale for not notifying (re-consenting) study participants0..1display
... ADMIN00Administrative Use Only0..1group
.... ADMIN01Link ID prefix0..1stringInitial Value: string = nme
.... 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 nme1.4

Answer options for nme3.2

Answer options for nme3.7.4

Answer options for nme3.7.6

Answer options for nme3.7.8

Answer options for nme3.17.4

Answer options for nme3.17.6

Answer options for nme4.1

Answer options for nme4.3

Answer options for nme4.5

Answer options for nme5.1

Answer options for nme5.3

Answer options for nme5.5

Answer options for nme6.1a

Answer options for nme6.1b

Answer options for nme6.3a

Answer options for nme6.3b

Answer options for nme6.5