Structure LinkId Text Cardinality Type Flags Description & Constraints NonMedical_events Questionnaire http://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevent-questionnaire-populate#1.0.0 nme1 Research Study 0..1 group nme1.1 Study Title 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value nme1.1_help Study Title from the Informed Consent 0..1 display nme1.3 IRB Protocol Number 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value nme1.3_help Number assigned by IRB; this number is the same as that on the Consent Form 0..1 display nme1.4 Status 0..1 choice Options: 4 options nme1.4_help Status of study research activities 0..1 display nme1.5 If partial, please explain: 0..1 text Enable When: nme1.4 = Partial voluntary hold on some research activities for all participants (explain below) (Temporary Codes#partial) nme1.5_help Explanation for voluntary hold on new participant enrollment. 0..1 display nme7 Organization/Site 0..1 group nme7.1 Where Adverse Non-Medical Event Occurred 0..1 group nme7.1.8 Did the Adverse Non-Medical Event occur at the lead principal investigator site? 1..1 choice Options: 2 options nme7.1.8_help Select "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..1 display nme7.1.11 Did the Adverse Non-Medical Event occur at one of the relying sites? 1..1 choice Enable When: nme7.1.8 = No (expandedYes-NoIndicator#N) Options: 2 options ExternalDataFor_nme7.1.9 External Data For linkId nme7.1.9 0..* open-choice Expressions: Initial Value: %lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value nme7.1.9 If 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..1 choice Enable When: nme7.1.8 = No (expandedYes-NoIndicator#N) nme7.1.11 = Yes (expandedYes-NoIndicator#Y) nme7.1.9_help This 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..1 display nme7.1.12 If 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..1 display Enable When: nme7.1.8 = No (expandedYes-NoIndicator#N) nme7.1.11 = No (expandedYes-NoIndicator#N) nme7.1.1 Name of organization/site where the Adverse Non-Medical Event occurred 0..1 string Enable When: nme7.1.8 = Yes (expandedYes-NoIndicator#Y) nme7.1.11 exists true 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) nme7.1.2 City 0..1 string Enable When: nme7.1.8 = Yes (expandedYes-NoIndicator#Y) nme7.1.11 exists true 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) nme7.1.3 State 0..1 string Enable When: nme7.1.8 = Yes (expandedYes-NoIndicator#Y) nme7.1.11 exists true 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) nme7.1.4 Country 0..1 string Enable When: nme7.1.8 = Yes (expandedYes-NoIndicator#Y) nme7.1.11 exists true 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) nme7.2 Responsibility for Adverse Non-Medical Event Reporting 0..1 group Enable When: nme7.1.8 = Yes (expandedYes-NoIndicator#Y) nme7.1.11 exists true nme7.2.8 If 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..1 choice Enable When: nme7.1.8 = No (expandedYes-NoIndicator#N) Options: 2 options nme7.2.8_help Select "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..1 display nme7.2.1 Name of organization/site which is recording the Adverse Non-Medical Event 0..1 string Expressions: 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) ) nme7.2.2 City 0..1 string Expressions: 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) ) nme7.2.3 State 0..1 string Expressions: 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) ) nme7.2.4 Country 0..1 string Expressions: 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_help Location 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..1 display nme8 Site Principal Investigator for the site where Adverse Non-Medical Event occurred 0..1 group Enable When: nme7.1.8 = Yes (expandedYes-NoIndicator#Y) nme7.1.11 exists true nme8.1 First Name 0..1 string Expressions: 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_help First or given name of the site PI 0..1 display nme8.4 Last Name 0..1 string Expressions: 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_help Surname or family name 0..1 display nme8.5 Suffix 0..1 string Expressions: 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_help Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. 0..1 display nme8.6 Degree(s) 0..1 string Expressions: 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_help Professional and Academic degrees of the site principal investigator 0..1 display nme8.2 Phone 0..1 string Expressions: 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_help 10 digit phone number, including area code 0..1 display nme8.3 Email 0..1 string Expressions: 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_help Principal Investigator at Relying Site conducting the study 0..1 display nme3 Report 0..1 group nme3_help Non-medical adverse event report 0..1 display nme3.1 Report Date 0..1 date nme3.1_help Date report is created 0..1 display nme3.2 Report Status 0..1 choice Options: 2 options nme3.2_help Indicator if report is the Initial report or follow-up report 0..1 display nme3.3 Select at least one of the following criteria: 0..1 group nme3.3_help Details about adverse non-medical event 0..1 display nme3.3.4 New information resulted in unexpected change in risks of the research 0..1 boolean nme3.3.4_help Indicator if new information resulted in unexpected change in risks of research 0..1 display nme3.3.5 New or increased risk 0..1 group Enable When: nme3.3.4 = true nme3.3.5.1 Date: 0..1 date nme3.3.5.1_help Date new or increased risk first documented 0..1 display nme3.3.5.2 Date discovered: 0..1 date nme3.3.5.2_help Date new or increased risk discovered 0..1 display nme3.3.5.3 Description: 0..1 text nme3.3.5.3_help Description of new or increased risk 0..1 display nme3.3.6 Unanticipated Problem Involving Risk to Participants or Others 0..1 boolean nme3.3.6_help Indicator if problem Involved risk to participants or others 0..1 display nme3.3.7 Unanticipated Problem 0..1 group Enable When: nme3.3.6 = true nme3.3.7.1 Event date: 0..1 date nme3.3.7.1_help Date event occurred 0..1 display nme3.3.7.2 Date event became aware to study team: 0..1 date nme3.3.7.2_help Date site research team first became aware of unanticipated problem 0..1 display nme3.3.7.3 Event Summary: 0..1 text nme3.3.7.3_help Summary description of unanticipated problem 0..1 display nme3.3.7.4 Was this event Unexpected? 0..1 choice Options: 2 options nme3.3.7.4_help Indicator if unanticipated problem was unexpected 0..1 display nme3.3.7.5 If yes, please explain: 0..1 text Enable When: nme3.3.7.4 = Yes (expandedYes-NoIndicator#Y) nme3.3.7.5_help Explanation for why unanticipated problem was unexpected 0..1 display nme3.3.7.6 Was this event Related or Possibly Related to participation in the research? 0..1 choice Options: 2 options nme3.3.7.6_help Unanticipated problem associated with participation in the research study 0..1 display nme3.3.7.7 If yes, please explain: 0..1 text Enable When: nme3.3.7.6 = Yes (expandedYes-NoIndicator#Y) nme3.3.7.7_help Explanation for why unanticipated problem is associated with participation in this research 0..1 display nme3.3.7.8 Does this event suggest that the research places participant(s) or others at a greater Risk of harm than was previously known? 0..1 choice Options: 2 options nme3.3.7.8_help Indicator if unanticipated problem increased risk of harm to participants 0..1 display nme3.3.7.9 If yes, please explain: 0..1 text Enable When: nme3.3.7.8 = Yes (expandedYes-NoIndicator#Y) nme3.3.7.9_help Explanation for why unanticipated problem is associated with increased risk of harm for research participants 0..1 display nme3.3.8 Protocol Deviation (accidental or unintentional) 0..1 boolean nme3.3.8_help Indicator protocol deviation was accidental or unintentional 0..1 display nme3.3.9 Protocol Deviation (Non-Compliance) 0..1 group Enable When: nme3.3.8 = true nme3.3.9.1 Date: 0..1 date nme3.3.9.1_help Date non-compliance first identified 0..1 display nme3.3.9.2 Date discovered: 0..1 date nme3.3.9.2_help Date site research team first discovered non-compliance protocol deviation 0..1 display nme3.3.9.3 Description: 0..1 text nme3.3.9.3_help Description of non-compliance protocol deviation 0..1 display nme3.3.9.4 Does the deviation involve any of the following? (Select all that apply) 0..1 group nme3.3.9.4.1 Failure to obtain informed consent when IRB deemed required 0..1 boolean nme3.3.9.4.1_help Informed consent not obtained when required by IRB 0..1 display nme3.3.9.4.2 Modifying the protocol without IRB approval, except to avoid hazard to participants 0..1 boolean nme3.3.9.4.2_help Protocol modified without IRB approval 0..1 display nme3.3.9.4.3 Conducting research prior to IRB approval, during an IRB suspension or after IRB approval ends 0..1 boolean nme3.3.9.4.3_help Conducting research without IRB approval 0..1 display nme3.3.9.4.4 Explain any Checked items 0..1 text Enable When: nme3.3.9.4.1 = true nme3.3.9.4.2 = true nme3.3.9.4.3 = true nme3.3.9.4.4_help Explanation for why protocol deviation category checked 0..1 display nme3.3.9.5 Was the deviation a substantive change from the protocol adversely affecting any of the following? (Select all that apply) 0..1 group nme3.3.9.5.1 The rights, welfare, or safety of the participants 0..1 boolean nme3.3.9.5.2 The integrity of the research area 0..1 boolean nme3.3.9.5.3 The participants' willingness to continue participation 0..1 boolean nme3.3.9.5.4 Explain any Checked items 0..1 text Enable When: nme3.3.9.5.1 = true nme3.3.9.5.2 = true nme3.3.9.5.3 = true nme3.3.10 A breach of Confidentiality 0..1 boolean nme3.3.10_help Indicator of breach of confidentiality 0..1 display nme3.3.11 Breach of Confidentiality 0..1 group Enable When: nme3.3.10 = true nme3.3.11.1 Date breach occurred 0..1 date nme3.3.11.1_help Date breach of confidentiality first documented 0..1 display nme3.3.11.2 Date discovered: 0..1 date nme3.3.11.2_help Date site study team discovered breach of confidentiality 0..1 display nme3.3.11.3 Description: 0..1 text nme3.3.11.3_help Breach of confidentiality description 0..1 display nme3.3.12 Incarceration of a participant in a protocol not approved to enroll prisoners 0..1 boolean nme3.3.12_help Indicator of a study participant incarcerated when the protocol is not approved for prisoner enrollment 0..1 display nme3.3.13 Incarceration 0..1 group Enable When: nme3.3.12 = true nme3.3.13.1 Date: 0..1 date nme3.3.13.1_help Date site first documented participant incarceration. 0..1 display nme3.3.13.2 Date incarceration was discovered: 0..1 date nme3.3.13.2_help Data site study team discovered patient incarceration 0..1 display nme3.3.13.3 Description: 0..1 text nme3.3.13.3_help Description of patient incarceration 0..1 display nme3.3.14 Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team 0..1 boolean nme3.3.14_help Indicator if participant complaint of unexpected risks was not resolved by study team. Complaint information is related to study site. 0..1 display nme3.3.15 Participant Complaint 0..1 group Enable When: nme3.3.14 = true nme3.3.15.1 Complaint Date: 0..1 date nme3.3.15.1_help Date a participant complaint was first documented 0..1 display nme3.3.15.2 Date received: 0..1 date nme3.3.15.2_help Date site personnel first received a participant complaint 0..1 display nme3.3.15.3 Description: 0..1 text nme3.3.15.3_help Description of participant unexpected risk complaint 0..1 display nme3.3.16 Other Type of Adverse Non-Medical Event 0..1 boolean nme3.3.16_help Indicator for other type of Adverse Non-Medical Event 0..1 display nme3.3.17 Other Type 0..1 group Enable When: nme3.3.16 = true nme3.3.17.1 Event date: 0..1 date nme3.3.17.1_help Date event occurred 0..1 display nme3.3.17.2 Date study team became aware of event: 0..1 date nme3.3.17.2_help Date site research team first became aware of the event 0..1 display nme3.3.17.3 Event Summary: 0..1 text nme3.3.17.3_help Summary description of the event 0..1 display nme3.3.17.4 Was this Adverse Non-Medical Event Unexpected? 0..1 choice Options: 2 options nme3.3.17.4_help Indicator if event was unexpected 0..1 display nme3.3.17.5 If yes, please explain: 0..1 text Enable When: nme3.3.17.4 = Yes (expandedYes-NoIndicator#Y) nme3.3.17.5_help Explanation for why event was unexpected 0..1 display nme3.3.17.6 Was this event Related or Possibly Related to participation in the research? 0..1 choice Options: 2 options nme3.3.17.6_help Adverse Non-Medical Event association with participation in the research study 0..1 display nme3.3.17.7 If yes, please explain: 0..1 text Enable When: nme3.3.17.6 = Yes (expandedYes-NoIndicator#Y) nme3.3.17.7_help Explanation for why the event is associated with participation in this research 0..1 display nme4 Reporting 0..1 group nme4_help Reporting information to Sponsor and both relying and reviewing IRBs 0..1 display nme4.1 Was the Sponsor notified? 0..1 choice Options: 2 options nme4.1_help Indicator if Sponsor was notified of non-medical adverse event 0..1 display nme4.2 Notification date: 0..1 date Enable When: nme4.1 = Yes (expandedYes-NoIndicator#Y) nme4.2_help Date sponsor notified of non-medical adverse event 0..1 display nme4.3 Was the IRB notified? 0..1 choice Options: 2 options nme4.3_help Indicator if study site IRB notified of non-medical adverse event 0..1 display nme4.4 Notification date: 0..1 date Enable When: nme4.3 = Yes (expandedYes-NoIndicator#Y) nme4.4_help Date study site IRB notified of non-medical adverse event 0..1 display nme4.5 Were any Other Parties notified? 0..1 choice Options: 2 options nme4.5_help Other parties notified of non-medical adverse event (such as coordinating center, other study sites, FDA) 0..1 display nme4.6 List other notified parties 0..1 text Enable When: nme4.5 = Yes (expandedYes-NoIndicator#Y) nme5 Corrective and Preventative Action Plan 0..1 group nme5.1 Was a Root Cause analysis performed? 0..1 choice Options: 3 options nme5.1_help Indicataor if analysis of underlying causes or problems that led to the non-medical adverse event was performed 0..1 display nme5.2a If yes, provide determination: 0..1 text Enable When: nme5.1 = Done, performed or completed (Temporary Codes#completed) nme5.2a_help Description of what the root cause analysis determined the adverse event was caused by 0..1 display nme5.2b If pending, describe status and interim findings, if any: 0..1 text Enable When: nme5.1 = Pending - Currently under development (Temporary Codes#pending) nme5.2b_help Describe status and any interim findings of the root cause analysis 0..1 display nme5.3 Was Corrective Action implemented? 0..1 choice Options: 3 options nme5.3_help Indicator if corrective action is implemented for non-medical adverse event 0..1 display nme5.4 If Corrective Action was implemented or is pending, provide a summary: 0..1 text Enable When: nme5.3 = Done, performed or completed (Temporary Codes#completed) nme5.3 = Pending - Currently under development (Temporary Codes#pending) nme5.4_help Summary of corrective action implemented for non-medical adverse event. If still pending, provide a status of the corrective action plan 0..1 display nme5.5 Was Preventitive Action implemented? 0..1 choice Options: 3 options nme5.5_help Indicator if preventative action for non-medical adverse event is implemented 0..1 display nme5.6 If Preventitive Action was implemented or is pending, provide a summary: 0..1 text Enable When: nme5.5 = Done, performed or completed (Temporary Codes#completed) nme5.5 = Pending - Currently under development (Temporary Codes#pending) nme5.6_help Summary of preventative action implemented for non-medical adverse event. If still pending, provide status. 0..1 display nme6 Study Protocol and Informed Consent 0..1 group nme6_help Description of protocol and informed consent changes 0..1 display nme6.1a Are changes required to the Study Protocol as a result of this report? 0..1 choice Options: 2 options nme6.1a_help Indicator if changes are required in study protocol resulting from the non-medical adverse event report 0..1 display nme6.1b Reason(s) why changes are not required in the Study Protocol: 1..* choice Enable When: nme6.1a = No (expandedYes-NoIndicator#N) Options: 3 options nme6.2 Justify 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..1 text Enable When: nme6.1a = No (expandedYes-NoIndicator#N) nme6.1b = Other reason (Temporary Codes#otherreason) nme6.2_help Justification for decision not to change study protocol based upon non-medical adverse event report 0..1 display nme6.3a Are changes required to the Informed Consent as a result of this report? 0..1 choice Options: 2 options nme6.3a_help Indicator if changes are required to the informed consent as a result of the non-medical adverse event report 0..1 display nme6.3b Reason(s) why changes are not required in the Informed Consent: 1..* choice Enable When: nme6.3a = No (expandedYes-NoIndicator#N) Options: 3 options nme6.4 Justify 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..1 text Enable When: nme6.3a = No (expandedYes-NoIndicator#N) nme6.3b = Other reason (Temporary Codes#otherreason) nme6.4_help Justification for decision not to change informed consent based upon non-medical adverse event report 0..1 display nme6.5 Are notifications or re-consenting of participants required as a result of changes in Study Protocol or Informed Consent? 0..1 choice Enable When: nme6.1a = Yes (expandedYes-NoIndicator#Y) nme6.3a = Yes (expandedYes-NoIndicator#Y) Options: 2 options nme6.5_help Indicator if notification or reconsenting of participants is required due to changes in Study Protocol or Informed Consent 0..1 display nme6.6 If yes, detail how the notification and/or re-consent will occur: 0..1 text Enable When: nme6.5 = Yes (expandedYes-NoIndicator#Y) nme6.6_help Description of how notification or re-consent will occur 0..1 display nme6.7 If no, justify your decision to not notify (re-consent) participants: 0..1 text Enable When: nme6.5 = No (expandedYes-NoIndicator#N) nme6.7_help Rationale for not notifying (re-consenting) study participants 0..1 display nme11 Optional Attachments 0..* group nme11.1 Describe the file that is being attached (optional) 0..1 string nme11.2 Attachment 0..1 attachment nme11_help Attachments related to the Adverse Non-Medical Event can be included here. 0..1 display ADMIN00 Administrative Use Only 0..1 group ADMIN01 Link ID prefix 0..1 string Initial Value: string = nme ADMIN02 Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any 0..1 string Initial Value: string = temporarily unavailable Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value ADMIN03 ID of the Research Study FHIR Resource associated with the study Questionnaire Responses 0..1 string Initial Value: string = temporarily unavailable Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value ADMIN04 Questionnaire Response ID of the local considerations Questionnaire Response, if any 0..1 string 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")
The content of the Questionnaire Response transferred to this Questionnaire during form launch
The Initiate a Study Questionnaire Response content that will be used to pre-populate this Questionnaire
variable to store the incoming data from the launchContext extension for populate and other expressions
event happened at the lead PI site/coordinating center
%resource.descendants().where(linkId = 'nme7.1.8').answer.valueCoding.code
%resource.descendants().where(linkId = 'nme7.1.9').answer.value.display
%resource.descendants().where(linkId = 'nme7.2.8').answer.valueCoding.code
Unanticipated Problems Involving Risk to Subjects or Others (UPIRTSO)/Adverse Non-Medical Event Questionnaire
HL7 International - Biomedical Research and Regulation
%lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value
Number assigned by IRB; this number is the same as that on the Consent Form
All research activities temporarily and voluntarily stopped for all participants
Partial voluntary hold on some research activities for all participants (explain below)
Voluntary hold on new participant enrollment only
Explanation for voluntary hold on new participant enrollment.
Where Adverse Non-Medical Event Occurred
Did the Adverse Non-Medical Event occur at the lead principal investigator site?
Select "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.
Did the Adverse Non-Medical Event occur at one of the relying sites?
%lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value
See FHIR Specification Feedback Jira ticket FHIR-36338. Information obtained from other types of external sources (e.g. launch context, fhir-x-query, etc.) SHOULD only be used for initialExpression and calculatedExpression logic. Other behavior such as enableWhen or answerExpression should always be driven off of answers within the Questionnaire (even if they are hidden answers that are populated from an initialExpression).
%resource.repeat(item).where(linkId = 'ExternalDataFor_nme7.1.9').answer.value
If 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.
This 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.
If 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.
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)
Name of organization/site where the Adverse Non-Medical Event occurred
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)
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)
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)
Responsibility for Adverse Non-Medical Event Reporting
If 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?
Select "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.
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) )
Name of organization/site which is recording the Adverse Non-Medical Event
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) )
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) )
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) )
Location 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.
Site Principal Investigator for the site where Adverse Non-Medical Event occurred
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)
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)
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)
Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.
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)
Professional and Academic degrees of the site principal investigator
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)
10 digit phone number, including area code
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)
Principal Investigator at Relying Site conducting the study
Indicator if report is the Initial report or follow-up report
Select at least one of the following criteria:
New information resulted in unexpected change in risks of the research
Indicator if new information resulted in unexpected change in risks of research
color:#425caf; font-size: 115%; font-weight:bold
Date new or increased risk first documented
Unanticipated Problem Involving Risk to Participants or Others
Indicator if problem Involved risk to participants or others
Date site research team first became aware of unanticipated problem
Summary description of unanticipated problem
Indicator if unanticipated problem was unexpected
Explanation for why unanticipated problem was unexpected
Was this event Related or Possibly Related to participation in the research?
Unanticipated problem associated with participation in the research study
Explanation for why unanticipated problem is associated with participation in this research
Does this event suggest that the research places participant(s) or others at a greater Risk of harm than was previously known?
Indicator if unanticipated problem increased risk of harm to participants
Explanation for why unanticipated problem is associated with increased risk of harm for research participants
Protocol Deviation (accidental or unintentional)
Indicator protocol deviation was accidental or unintentional
Date site research team first discovered non-compliance protocol deviation
Description of non-compliance protocol deviation
Does the deviation involve any of the following? (Select all that apply)
Failure to obtain informed consent when IRB deemed required
Informed consent not obtained when required by IRB
Modifying the protocol without IRB approval, except to avoid hazard to participants
Conducting research prior to IRB approval, during an IRB suspension or after IRB approval ends
Conducting research without IRB approval
Explanation for why protocol deviation category checked
Was the deviation a substantive change from the protocol adversely affecting any of the following? (Select all that apply)
The rights, welfare, or safety of the participants
The participants' willingness to continue participation
Date breach of confidentiality first documented
Date site study team discovered breach of confidentiality
Incarceration of a participant in a protocol not approved to enroll prisoners
Indicator of a study participant incarcerated when the protocol is not approved for prisoner enrollment
Date site first documented participant incarceration.
Data site study team discovered patient incarceration
Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team
Indicator if participant complaint of unexpected risks was not resolved by study team. Complaint information is related to study site.
Date a participant complaint was first documented
Date site personnel first received a participant complaint
Description of participant unexpected risk complaint
Indicator for other type of Adverse Non-Medical Event
Date site research team first became aware of the event
Was this Adverse Non-Medical Event Unexpected?
Explanation for why event was unexpected
Adverse Non-Medical Event association with participation in the research study
Explanation for why the event is associated with participation in this research
Reporting information to Sponsor and both relying and reviewing IRBs
Indicator if Sponsor was notified of non-medical adverse event
Date sponsor notified of non-medical adverse event
Indicator if study site IRB notified of non-medical adverse event
Date study site IRB notified of non-medical adverse event
Other parties notified of non-medical adverse event (such as coordinating center, other study sites, FDA)
Indicataor if analysis of underlying causes or problems that led to the non-medical adverse event was performed
Description of what the root cause analysis determined the adverse event was caused by
If pending, describe status and interim findings, if any:
Describe status and any interim findings of the root cause analysis
Indicator if corrective action is implemented for non-medical adverse event
If Corrective Action was implemented or is pending, provide a summary:
Summary of corrective action implemented for non-medical adverse event. If still pending, provide a status of the corrective action plan
Indicator if preventative action for non-medical adverse event is implemented
If Preventitive Action was implemented or is pending, provide a summary:
Summary of preventative action implemented for non-medical adverse event. If still pending, provide status.
Description of protocol and informed consent changes
Are changes required to the Study Protocol as a result of this report?
Indicator if changes are required in study protocol resulting from the non-medical adverse event report
Reason(s) why changes are not required in the Study Protocol:
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)
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
Justify 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):
Justification for decision not to change study protocol based upon non-medical adverse event report
Are changes required to the Informed Consent as a result of this report?
Indicator if changes are required to the informed consent as a result of the non-medical adverse event report
Reason(s) why changes are not required in the Informed Consent:
Justify 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):
Justification for decision not to change informed consent based upon non-medical adverse event report
Are notifications or re-consenting of participants required as a result of changes in Study Protocol or Informed Consent?
Indicator if notification or reconsenting of participants is required due to changes in Study Protocol or Informed Consent
If yes, detail how the notification and/or re-consent will occur:
Description of how notification or re-consent will occur
If no, justify your decision to not notify (re-consent) participants:
Rationale for not notifying (re-consenting) study participants
Describe the file that is being attached (optional)
Attachments related to the Adverse Non-Medical Event can be included here.
%lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value
Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any
%lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value
ID of the Research Study FHIR Resource associated with the study Questionnaire Responses
Questionnaire Response ID of the local considerations Questionnaire Response, if any