Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use

Single Institutional Review Board (sIRB) Implementation Guide, published by HL7 International - BR&R Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/fhir-sirb/ and changes regularly. 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 2023-04-24 | Computable Name: NonMedical_events

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")