Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use United States of America flag

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

Questionnaire: Adverse Non-Medical Event Questionnaire

Official URL: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevent-questionnaire-populate Version: 1.0.0
Draft as of 2023-04-20 Computable Name: NonMedical_events
Structure
LinkIdTextCardinalityTypeFlagsDescription & Constraintsdoco
.. NonMedical_eventsQuestionnairehttp://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevent-questionnaire-populate#1.0.0
... nme1Research Study0..1group
.... nme1.1Study Title0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value
..... nme1.1_helpStudy Title from the Informed Consent0..1display
.... nme1.3IRB Protocol Number0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value
..... nme1.3_helpNumber assigned by IRB; this number is the same as that on the Consent Form0..1display
.... nme1.4Status0..1choiceOptions: 4 options
..... nme1.4_helpStatus of study research activities0..1display
.... nme1.5If partial, please explain:0..1textEnable When: nme1.4 = Partial voluntary hold on some research activities for all participants (explain below) (Temporary Codes#partial)
..... nme1.5_helpExplanation for voluntary hold on new participant enrollment.0..1display
... nme7Organization/Site0..1group
.... nme7.1Where Adverse Non-Medical Event Occurred0..1group
..... nme7.1.8Did the Adverse Non-Medical Event occur at the lead principal investigator site?1..1choiceOptions: 2 options
...... nme7.1.8_helpSelect "Yes" if the Adverse Non-Medical Event occurred at the lead principal investigator site, the study coordinating center or other administrative unit for the overall study.0..1display
..... nme7.1.11Did the Adverse Non-Medical Event occur at one of the relying sites?1..1choiceEnable When: nme7.1.8 = No (expandedYes-NoIndicator#N)
Options: 2 options
..... ExternalDataFor_nme7.1.9External Data For linkId nme7.1.90..*open-choiceiconExpressions:
  • Initial Value: %lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value
..... 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.0..1choiceEnable When:
...... nme7.1.9_helpThis question and its answer will not print on the Adverse Non-Medical Event Form but are necessary for the form logic. If you do not want pre-population to occur, leave this question blank and manually fill in the relying institution and relying site principal investigator details.0..1display
..... nme7.1.12If the Adverse Non-Medical Event occurred at another organization (unrelated to the lead principal investigator organization/site or relying sites), fill in the details below.0..1displayEnable When:
..... nme7.1.1Name of organization/site where the Adverse Non-Medical Event occurred0..1stringEnable When:
Expressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value)
..... nme7.1.2City0..1stringEnable When:
Expressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.2').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.2').answer.value)
..... nme7.1.3State0..1stringEnable When:
Expressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.3').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.3').answer.value)
..... nme7.1.4Country0..1stringEnable When:
Expressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.5').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.5').answer.value)
.... nme7.2Responsibility for Adverse Non-Medical Event Reporting0..1groupEnable When:
..... 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?1..1choiceEnable When: nme7.1.8 = No (expandedYes-NoIndicator#N)
Options: 2 options
...... nme7.2.8_helpSelect "Yes" if the Adverse Non-Medical Event is being recorded by the lead principal investigator site, the study coordinating center or other administrative unit for the overall study.0..1display
..... nme7.2.1Name of organization/site which is recording the Adverse Non-Medical Event0..1stringExpressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y' or %relyingSiteEventReportedByLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value, iif(%relyingSiteEventReportedByLeadPISite = 'N', %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value) )
..... nme7.2.2City0..1stringExpressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y' or %relyingSiteEventReportedByLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.2').answer.value, iif(%relyingSiteEventReportedByLeadPISite = 'N', %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.2').answer.value) )
..... nme7.2.3State0..1stringExpressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y' or %relyingSiteEventReportedByLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.3').answer.value, iif(%relyingSiteEventReportedByLeadPISite = 'N', %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.3').answer.value) )
..... nme7.2.4Country0..1stringExpressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y' or %relyingSiteEventReportedByLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.5').answer.value, iif(%relyingSiteEventReportedByLeadPISite = 'N', %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.5').answer.value) )
.... nme7_helpLocation where Adverse Non-Medical Event occurred. Adverse non-medical events are: unexpected, related or possibly related to participation in the research, and place the participants or others at a greater risk of harm than was previously known or recognized.0..1display
... nme8Site Principal Investigator for the site where Adverse Non-Medical Event occurred0..1groupEnable When:
.... nme8.1First Name0..1stringExpressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.1').answer.value)
..... nme8.1_helpFirst or given name of the site PI0..1display
.... nme8.4Last Name0..1stringExpressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.2').answer.value)
..... nme8.4_helpSurname or family name0..1display
.... nme8.5Suffix0..1stringExpressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.3').answer.value)
..... nme8.5_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.0..1display
.... nme8.6Degree(s)0..1stringExpressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.4').answer.value)
..... nme8.6_helpProfessional and Academic degrees of the site principal investigator0..1display
.... nme8.2Phone0..1stringExpressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value)
..... nme8.2_help10 digit phone number, including area code0..1display
.... nme8.3Email0..1stringExpressions:
  • Calculated Value: iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value)
.... nme8_helpPrincipal Investigator at Relying Site conducting the study0..1display
... nme3Report0..1group
.... nme3_helpNon-medical adverse event report0..1display
.... nme3.1Report Date0..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
.... nme3.3Select at least one of the following criteria:0..1group
..... nme3.3_helpDetails about adverse non-medical event0..1display
..... nme3.3.4New information resulted in unexpected change in risks of the research0..1boolean
...... nme3.3.4_helpIndicator if new information resulted in unexpected change in risks of research0..1display
..... nme3.3.5New or increased risk0..1groupEnable When: nme3.3.4 = true
...... nme3.3.5.1Date:0..1date
....... nme3.3.5.1_helpDate new or increased risk first documented0..1display
...... nme3.3.5.2Date discovered:0..1date
....... nme3.3.5.2_helpDate new or increased risk discovered0..1display
...... nme3.3.5.3Description:0..1text
....... nme3.3.5.3_helpDescription of new or increased risk0..1display
..... nme3.3.6Unanticipated Problem Involving Risk to Participants or Others0..1boolean
...... nme3.3.6_helpIndicator if problem Involved risk to participants or others0..1display
..... nme3.3.7Unanticipated Problem0..1groupEnable When: nme3.3.6 = true
...... nme3.3.7.1Event date:0..1date
....... nme3.3.7.1_helpDate event occurred0..1display
...... nme3.3.7.2Date event became aware to study team:0..1date
....... nme3.3.7.2_helpDate site research team first became aware of unanticipated problem0..1display
...... nme3.3.7.3Event Summary:0..1text
....... nme3.3.7.3_helpSummary description of unanticipated problem0..1display
...... nme3.3.7.4Was this event Unexpected?0..1choiceOptions: 2 options
....... nme3.3.7.4_helpIndicator if unanticipated problem was unexpected0..1display
...... nme3.3.7.5If yes, please explain:0..1textEnable When: nme3.3.7.4 = Yes (expandedYes-NoIndicator#Y)
....... nme3.3.7.5_helpExplanation for why unanticipated problem was unexpected0..1display
...... nme3.3.7.6Was this event Related or Possibly Related to participation in the research?0..1choiceOptions: 2 options
....... nme3.3.7.6_helpUnanticipated problem associated with participation in the research study0..1display
...... nme3.3.7.7If yes, please explain:0..1textEnable When: nme3.3.7.6 = Yes (expandedYes-NoIndicator#Y)
....... nme3.3.7.7_helpExplanation for why unanticipated problem is associated with participation in this research0..1display
...... 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?0..1choiceOptions: 2 options
....... nme3.3.7.8_helpIndicator if unanticipated problem increased risk of harm to participants0..1display
...... nme3.3.7.9If yes, please explain:0..1textEnable When: nme3.3.7.8 = Yes (expandedYes-NoIndicator#Y)
....... nme3.3.7.9_helpExplanation for why unanticipated problem is associated with increased risk of harm for research participants0..1display
..... nme3.3.8Protocol Deviation (accidental or unintentional)0..1boolean
...... nme3.3.8_helpIndicator protocol deviation was accidental or unintentional0..1display
..... nme3.3.9Protocol Deviation (Non-Compliance)0..1groupEnable When: nme3.3.8 = true
...... nme3.3.9.1Date:0..1date
....... nme3.3.9.1_helpDate non-compliance first identified0..1display
...... nme3.3.9.2Date discovered:0..1date
....... nme3.3.9.2_helpDate site research team first discovered non-compliance protocol deviation0..1display
...... nme3.3.9.3Description:0..1text
....... nme3.3.9.3_helpDescription of non-compliance protocol deviation0..1display
...... nme3.3.9.4Does the deviation involve any of the following? (Select all that apply)0..1group
....... nme3.3.9.4.1Failure to obtain informed consent when IRB deemed required0..1boolean
........ nme3.3.9.4.1_helpInformed consent not obtained when required by IRB0..1display
....... nme3.3.9.4.2Modifying the protocol without IRB approval, except to avoid hazard to participants0..1boolean
........ nme3.3.9.4.2_helpProtocol modified without IRB approval0..1display
....... nme3.3.9.4.3Conducting research prior to IRB approval, during an IRB suspension or after IRB approval ends0..1boolean
........ nme3.3.9.4.3_helpConducting research without IRB approval0..1display
....... nme3.3.9.4.4Explain any Checked items0..1textEnable When:
........ nme3.3.9.4.4_helpExplanation for why protocol deviation category checked0..1display
...... nme3.3.9.5Was the deviation a substantive change from the protocol adversely affecting any of the following? (Select all that apply)0..1group
....... nme3.3.9.5.1The rights, welfare, or safety of the participants0..1boolean
....... nme3.3.9.5.2The integrity of the research area0..1boolean
....... nme3.3.9.5.3The participants' willingness to continue participation0..1boolean
....... nme3.3.9.5.4Explain any Checked items0..1textEnable When:
..... nme3.3.10A breach of Confidentiality0..1boolean
...... nme3.3.10_helpIndicator of breach of confidentiality0..1display
..... nme3.3.11Breach of Confidentiality0..1groupEnable When: nme3.3.10 = true
...... nme3.3.11.1Date breach occurred0..1date
....... nme3.3.11.1_helpDate breach of confidentiality first documented0..1display
...... nme3.3.11.2Date discovered:0..1date
....... nme3.3.11.2_helpDate site study team discovered breach of confidentiality0..1display
...... nme3.3.11.3Description:0..1text
....... nme3.3.11.3_helpBreach of confidentiality description0..1display
..... nme3.3.12Incarceration of a participant in a protocol not approved to enroll prisoners0..1boolean
...... nme3.3.12_helpIndicator of a study participant incarcerated when the protocol is not approved for prisoner enrollment0..1display
..... nme3.3.13Incarceration0..1groupEnable When: nme3.3.12 = true
...... nme3.3.13.1Date:0..1date
....... nme3.3.13.1_helpDate site first documented participant incarceration.0..1display
...... nme3.3.13.2Date incarceration was discovered:0..1date
....... nme3.3.13.2_helpData site study team discovered patient incarceration0..1display
...... nme3.3.13.3Description:0..1text
....... nme3.3.13.3_helpDescription of patient incarceration0..1display
..... nme3.3.14Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team0..1boolean
...... nme3.3.14_helpIndicator if participant complaint of unexpected risks was not resolved by study team. Complaint information is related to study site.0..1display
..... nme3.3.15Participant Complaint0..1groupEnable When: nme3.3.14 = true
...... nme3.3.15.1Complaint Date:0..1date
....... nme3.3.15.1_helpDate a participant complaint was first documented0..1display
...... nme3.3.15.2Date received:0..1date
....... nme3.3.15.2_helpDate site personnel first received a participant complaint0..1display
...... nme3.3.15.3Description:0..1text
....... nme3.3.15.3_helpDescription of participant unexpected risk complaint0..1display
..... nme3.3.16Other Type of Adverse Non-Medical Event0..1boolean
...... nme3.3.16_helpIndicator for other type of Adverse Non-Medical Event0..1display
..... nme3.3.17Other Type0..1groupEnable When: nme3.3.16 = true
...... nme3.3.17.1Event date:0..1date
....... nme3.3.17.1_helpDate event occurred0..1display
...... nme3.3.17.2Date study team became aware of event:0..1date
....... nme3.3.17.2_helpDate site research team first became aware of the event0..1display
...... nme3.3.17.3Event Summary:0..1text
....... nme3.3.17.3_helpSummary description of the event0..1display
...... nme3.3.17.4Was this Adverse Non-Medical Event Unexpected?0..1choiceOptions: 2 options
....... nme3.3.17.4_helpIndicator if event was unexpected0..1display
...... nme3.3.17.5If yes, please explain:0..1textEnable When: nme3.3.17.4 = Yes (expandedYes-NoIndicator#Y)
....... nme3.3.17.5_helpExplanation for why event was unexpected0..1display
...... nme3.3.17.6Was this event Related or Possibly Related to participation in the research?0..1choiceOptions: 2 options
....... nme3.3.17.6_helpAdverse Non-Medical Event association with participation in the research study0..1display
...... nme3.3.17.7If yes, please explain:0..1textEnable When: nme3.3.17.6 = Yes (expandedYes-NoIndicator#Y)
....... nme3.3.17.7_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: nme4.1 = Yes (expandedYes-NoIndicator#Y)
..... 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: nme4.3 = Yes (expandedYes-NoIndicator#Y)
..... 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
.... nme4.6List other notified parties0..1textEnable When: nme4.5 = Yes (expandedYes-NoIndicator#Y)
... nme5Corrective and Preventative Action Plan0..1group
.... 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: nme5.1 = Done, performed or completed (Temporary Codes#completed)
..... 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: nme5.1 = Pending - Currently under development (Temporary Codes#pending)
..... 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:
  • nme5.3 = Done, performed or completed (Temporary Codes#completed)
  • nme5.3 = Pending - Currently under development (Temporary Codes#pending)
..... 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:
  • nme5.5 = Done, performed or completed (Temporary Codes#completed)
  • nme5.5 = Pending - Currently under development (Temporary Codes#pending)
..... 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:1..*choiceiconEnable When: nme6.1a = No (expandedYes-NoIndicator#N)
Options: 3 options
.... nme6.2Justify your decision to not change the Study Protocol (for reasons other than Adverse Non-Medical Event consisted of a missed lab/assessment or missed treatment/dose):0..1textEnable When:
  • nme6.1a = No (expandedYes-NoIndicator#N)
  • nme6.1b = Other reason (Temporary Codes#otherreason)
..... 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:1..*choiceiconEnable When: nme6.3a = No (expandedYes-NoIndicator#N)
Options: 3 options
.... nme6.4Justify your decision to not change the Informed Consent (for reasons other than Adverse Non-Medical Event consisted of a missed lab/assessment or missed treatment/dose):0..1textEnable When:
  • nme6.3a = No (expandedYes-NoIndicator#N)
  • nme6.3b = Other reason (Temporary Codes#otherreason)
..... 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 changes in Study Protocol or Informed Consent?0..1choiceEnable When:
  • nme6.1a = Yes (expandedYes-NoIndicator#Y)
  • nme6.3a = Yes (expandedYes-NoIndicator#Y)

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: nme6.5 = Yes (expandedYes-NoIndicator#Y)
..... 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: nme6.5 = No (expandedYes-NoIndicator#N)
..... nme6.7_helpRationale for not notifying (re-consenting) study participants0..1display
... nme11Optional Attachments0..*group
.... nme11.1Describe the file that is being attached (optional)0..1string
.... nme11.2Attachment0..1attachment
.... nme11_helpAttachments related to the Adverse Non-Medical Event can be included here.0..1display
... ADMIN00Administrative Use Only0..1groupicon
.... ADMIN01Link ID prefix0..1stringiconInitial Value: string = nme
.... ADMIN02Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any0..1stringiconInitial Value: string = temporarily unavailable
Expressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value
.... ADMIN03ID of the Research Study FHIR Resource associated with the study Questionnaire Responses0..1stringiconInitial Value: string = temporarily unavailable
Expressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value
.... ADMIN04Questionnaire Response ID of the local considerations Questionnaire Response, if any0..1stringicon

doco Documentation for this format

Option Sets

Answer options for nme1.4

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#nochange ("No change in research activities")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#stopped ("All research activities temporarily and voluntarily stopped for all participants")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#partial ("Partial voluntary hold on some research activities for all participants (explain below)")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#hold ("Voluntary hold on new participant enrollment only")

Answer options for nme7.1.8

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for nme7.1.11

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for nme7.2.8

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for nme3.2

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#init ("Initial")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#followup ("Follow-up")

Answer options for nme3.3.7.4

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for nme3.3.7.6

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for nme3.3.7.8

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for nme3.3.17.4

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for nme3.3.17.6

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for nme4.1

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for nme4.3

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for nme4.5

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for nme5.1

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#completed ("Done, performed or completed")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#pending ("Pending - Currently under development")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#notundertaken ("Not done or undertaken")

Answer options for nme5.3

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#completed ("Done, performed or completed")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#pending ("Pending - Currently under development")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#notundertaken ("Not done or undertaken")

Answer options for nme5.5

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#completed ("Done, performed or completed")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#notundertaken ("Not done or undertaken")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#pending ("Pending - Currently under development")

Answer options for nme6.1a

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for nme6.1b

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#mla ("Adverse Non-Medical Event consisted of a missed lab or assessment by a participant (which does not jeopardize the study or increase risks to other participants)")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#mtd ("Adverse Non-Medical Event consisted of a missed treatment or dose by a participant (which does not jeopardize the study or increase risks to other participants")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#otherreason ("Other reason")

Answer options for nme6.3a

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for nme6.3b

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#mla ("Adverse Non-Medical Event consisted of a missed lab or assessment by a participant (which does not jeopardize the study or increase risks to other participants)")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#mtd ("Adverse Non-Medical Event consisted of a missed treatment or dose by a participant (which does not jeopardize the study or increase risks to other participants")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#otherreason ("Other reason")

Answer options for nme6.5

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")