sirb-nonmedicalevent-questionnaire-populate
type: Questionnaire
node role: treeRoot
id:
  v: sirb-nonmedicalevent-questionnaire-populate
text:
  status:
    v: generated
  div: Structure LinkId Text Cardinality Type Flags Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> 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 …
extension:
  extension:
    url:
      v: name
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: sourceQuestionnaireResponse
      display:
        v: The content of the Questionnaire Response transferred to this Questionnaire during form launch
  extension:
    url:
      v: type
    value:
      v: QuestionnaireResponse
  extension:
    url:
      v: description
    value:
      v: The Initiate a Study Questionnaire Response content that will be used to pre-populate this Questionnaire
  url:
    v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-launchContext
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: variable to store the incoming data from the launchContext extension for populate and other expressions
    name:
      v: lookupInitiateStudy
    language:
      v: text/fhirpath
    expression:
      v: %sourceQuestionnaireResponse
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: event happened at the lead PI site/coordinating center
    name:
      v: eventOccurredAtLeadPISite
    language:
      v: text/fhirpath
    expression:
      v: %resource.descendants().where(linkId = 'nme7.1.8').answer.valueCoding.code
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: relying site where NME occurred
    name:
      v: relyingSiteForForm
    language:
      v: text/fhirpath
    expression:
      v: %resource.descendants().where(linkId = 'nme7.1.9').answer.value.display
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: being reported by lead PI site
    name:
      v: relyingSiteEventReportedByLeadPISite
    language:
      v: text/fhirpath
    expression:
      v: %resource.descendants().where(linkId = 'nme7.2.8').answer.valueCoding.code
url:
  v: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevent-questionnaire-populate
version:
  v: 1.0.0
name:
  v: NonMedical_events
title:
  v: Unanticipated Problems Involving Risk to Subjects or Others (UPIRTSO)/Adverse Non-Medical Event Questionnaire
status:
  v: draft
experimental:
  v: false
subject type:
  v: ResearchStudy
date:
  v: 2023-04-24T20:03:27+00:00
publisher:
  v: HL7 International - BR&R Work Group
contact:
  name:
    v: HL7 International - Biomedical Research and Regulation
  telecom:
    system:
      v: url
    value:
      v: http://www.hl7.org/Special/committees/rcrim
jurisdiction:
  coding:
    system:
      v: urn:iso:std:iso:3166
    code:
      v: US
    display:
      v: United States of America
  text:
    v: United States of America
item:
  link id:
    v: nme1
  text:
    v: Research Study
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style
      value:
        v: color:#274e90; font-size: 150%
  type:
    v: group
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    link id:
      v: nme1.1
    text:
      v: Study Title
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: nme1.1_help
      text:
        v: Study Title from the Informed Consent
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    link id:
      v: nme1.3
    text:
      v: IRB Protocol Number
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: nme1.3_help
      text:
        v: Number assigned by IRB; this number is the same as that on the Consent Form
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme1.4
    text:
      v: Status
    type:
      v: choice
    required:
      v: false
    answer option:
      value: Coding
    answer option:
      value: Coding
    answer option:
      value: Coding
    answer option:
      value: Coding
    item:
      extension:
        value: CodeableConcept
      link id:
        v: nme1.4_help
      text:
        v: Status of study research activities
      type:
        v: display

v: text/fhirpath

v: %lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value

CodeableConcept
coding:
  system:
    v: http://hl7.org/fhir/questionnaire-item-control
  code:
    v: help
  display:
    v: Help-Button
text:
  v: Help-Button

v: text/fhirpath

v: %lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value

CodeableConcept
coding:
  system:
    v: http://hl7.org/fhir/questionnaire-item-control
  code:
    v: help
  display:
    v: Help-Button
text:
  v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: drop-down
display:
  v: Drop down

v: Drop down

v: nochange

v: No change in research activities

v: stopped

v: All research activities temporarily and voluntarily stopped for all participants

v: partial

v: Partial voluntary hold on some research activities for all participants (explain below)

v: hold

v: Voluntary hold on new participant enrollment only

CodeableConcept
coding:
  system:
    v: http://hl7.org/fhir/questionnaire-item-control
  code:
    v: help
  display:
    v: Help-Button
text:
  v: Help-Button

link id:
  v: nme1.5
text:
  v: If partial, please explain:
type:
  v: text
enable when:
  question:
    v: nme1.4
  operator:
    v: =
  answer: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: partial
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: nme1.5_help
  text:
    v: Explanation for voluntary hold on new participant enrollment.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: nme7
text:
  v: Organization/Site
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#274e90; font-size: 150%
type:
  v: group
required:
  v: false
item:
  link id:
    v: nme7.1
  text:
    v: Where Adverse Non-Medical Event Occurred
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style
      value:
        v: color:#2a623d; font-size: 125%
  type:
    v: group
  required:
    v: false
  repeats:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme7.1.8
    text:
      v: Did the Adverse Non-Medical Event occur at the lead principal investigator site?
    type:
      v: choice
    required:
      v: true
    answer option:
      value: Coding
    answer option:
      value: Coding
    item:
      extension:
        value: CodeableConcept
      link id:
        v: nme7.1.8_help
      text:
        v: 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.
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme7.1.11
    text:
      v: Did the Adverse Non-Medical Event occur at one of the relying sites?
    type:
      v: choice
    enable when:
      question:
        v: nme7.1.8
      operator:
        v: =
      answer: Coding
    required:
      v: true
    answer option:
      value: Coding
    answer option:
      value: Coding
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
      value:
        v: true
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/designNote
      value:
        v: 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).
    link id:
      v: ExternalDataFor_nme7.1.9
    text:
      v: External Data For linkId nme7.1.9
    type:
      v: open-choice
    required:
      v: false
    repeats:
      v: true
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-answerExpression
      value: Expression
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/designNote
      value:
        v: 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).
    link id:
      v: nme7.1.9
    text:
      v: 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.
    type:
      v: choice
    enable when:
      question:
        v: nme7.1.8
      operator:
        v: =
      answer: Coding
    enable when:
      question:
        v: nme7.1.11
      operator:
        v: =
      answer: Coding
    enable behavior:
      v: all
    item:
      extension:
        value: CodeableConcept
      link id:
        v: nme7.1.9_help
      text:
        v: 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.
      type:
        v: display
  item:
    link id:
      v: nme7.1.12
    text:
      v: 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.
    type:
      v: display
    enable when:
      question:
        v: nme7.1.8
      operator:
        v: =
      answer: Coding
    enable when:
      question:
        v: nme7.1.11
      operator:
        v: =
      answer: Coding
    enable behavior:
      v: all
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: nme7.1.1
    text:
      v: Name of organization/site where the Adverse Non-Medical Event occurred
    type:
      v: string
    enable when:
      question:
        v: nme7.1.8
      operator:
        v: =
      answer: Coding
    enable when:
      question:
        v: nme7.1.11
      operator:
        v: exists
      answer:
        v: true
    enable behavior:
      v: any
    required:
      v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: nme7.1.2

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: drop-down
display:
  v: Drop down

v: Drop down

v: Y

v: Yes

v: N

v: No

CodeableConcept
coding:
  system:
    v: http://hl7.org/fhir/questionnaire-item-control
  code:
    v: help
  display:
    v: Help-Button
text:
  v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: drop-down
display:
  v: Drop down

v: Drop down

v: N

v: Y

v: Yes

v: N

v: No

v: text/fhirpath

v: %lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: drop-down
display:
  v: Drop down

v: Drop down

v: text/fhirpath

v: %resource.repeat(item).where(linkId = 'ExternalDataFor_nme7.1.9').answer.value

v: N

v: Y

CodeableConcept
coding:
  system:
    v: http://hl7.org/fhir/questionnaire-item-control
  code:
    v: help
  display:
    v: Help-Button
text:
  v: Help-Button

v: N

v: N

v: text/fhirpath

v: 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)

v: Y

v: text/fhirpath

v: 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)

v: City

v: string

question:
  v: nme7.1.8
operator:
  v: =
answer: Coding
  system:
    v: http://terminology.hl7.org/CodeSystem/v2-0532
  code:
    v: Y

question:
  v: nme7.1.11
operator:
  v: exists
answer:
  v: true

v: any

v: false

extension:
  url:
    v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: 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)
link id:
  v: nme7.1.3
text:
  v: State
type:
  v: string
enable when:
  question:
    v: nme7.1.8
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
enable when:
  question:
    v: nme7.1.11
  operator:
    v: exists
  answer:
    v: true
enable behavior:
  v: any
required:
  v: false

extension:
  url:
    v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: 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)
link id:
  v: nme7.1.4
text:
  v: Country
type:
  v: string
enable when:
  question:
    v: nme7.1.8
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
enable when:
  question:
    v: nme7.1.11
  operator:
    v: exists
  answer:
    v: true
enable behavior:
  v: any
required:
  v: false

link id:
  v: nme7.2
text:
  v: Responsibility for Adverse Non-Medical Event Reporting
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#2a623d; font-size: 125%
type:
  v: group
enable when:
  question:
    v: nme7.1.8
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
enable when:
  question:
    v: nme7.1.11
  operator:
    v: exists
  answer:
    v: true
enable behavior:
  v: any
required:
  v: false
repeats:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: nme7.2.8
  text:
    v: 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?
  type:
    v: choice
  enable when:
    question:
      v: nme7.1.8
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
  required:
    v: true
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme7.2.8_help
    text:
      v: 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.
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: 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) )
  link id:
    v: nme7.2.1
  text:
    v: Name of organization/site which is recording the Adverse Non-Medical Event
  type:
    v: string
  required:
    v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: 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) )
  link id:
    v: nme7.2.2
  text:
    v: City
  type:
    v: string
  required:
    v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: 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) )
  link id:
    v: nme7.2.3
  text:
    v: State
  type:
    v: string
  required:
    v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: 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) )
  link id:
    v: nme7.2.4
  text:
    v: Country
  type:
    v: string
  required:
    v: false

v: drop-down

v: Drop down

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: help
      display:
        v: Help-Button
    text:
      v: Help-Button
link id:
  v: nme7_help
text:
  v: 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.
type:
  v: display

link id:
  v: nme8
text:
  v: Site Principal Investigator for the site where Adverse Non-Medical Event occurred
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#274e90; font-size: 150%
type:
  v: group
enable when:
  question:
    v: nme7.1.8
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
enable when:
  question:
    v: nme7.1.11
  operator:
    v: exists
  answer:
    v: true
enable behavior:
  v: any
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: 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)
  link id:
    v: nme8.1
  text:
    v: First Name
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme8.1_help
    text:
      v: First or given name of the site PI
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: 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)
  link id:
    v: nme8.4
  text:
    v: Last Name
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme8.4_help
    text:
      v: Surname or family name
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: 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)
  link id:
    v: nme8.5
  text:
    v: Suffix
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme8.5_help
    text:
      v: Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: 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)
  link id:
    v: nme8.6
  text:
    v: Degree(s)
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme8.6_help
    text:
      v: Professional and Academic degrees of the site principal investigator
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: 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)
  link id:
    v: nme8.2
  text:
    v: Phone
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme8.2_help
    text:
      v: 10 digit phone number, including area code
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: 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)
  link id:
    v: nme8.3
  text:
    v: Email
  type:
    v: string
  required:
    v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: nme8_help
  text:
    v: Principal Investigator at Relying Site conducting the study
  type:
    v: display

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

v: help

v: Help-Button

link id:
  v: nme3
text:
  v: Report
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#274e90; font-size: 150%
type:
  v: group
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: nme3_help
  text:
    v: Non-medical adverse event report
  type:
    v: display
item:
  link id:
    v: nme3.1
  text:
    v: Report Date
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.1_help
    text:
      v: Date report is created
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: nme3.2
  text:
    v: Report Status
  type:
    v: choice
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: init
      display:
        v: Initial
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: followup
      display:
        v: Follow-up
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.2_help
    text:
      v: Indicator if report is the Initial report or follow-up report
    type:
      v: display
item:
  link id:
    v: nme3.3
  text:
    v: Select at least one of the following criteria:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style
      value:
        v: color:#2a623d; font-size: 125%
  type:
    v: group
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3_help
    text:
      v: Details about adverse non-medical event
    type:
      v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.4
    text:
      v: New information resulted in unexpected change in risks of the research
    type:
      v: boolean
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: nme3.3.4_help
      text:
        v: Indicator if new information resulted in unexpected change in risks of research
      type:
        v: display
  item:
    link id:
      v: nme3.3.5
    text:
      v: New or increased risk
    type:
      v: group
    enable when:
      question:
        v: nme3.3.4
      operator:
        v: =
      answer:
        v: true
    required:
      v: false
    item:
      link id:
        v: nme3.3.5.1
      text:
        v: Date:
      type:
        v: date
      required:
        v: false
    item:
      link id:
        v: nme3.3.5.2
      text:
        v: Date discovered:
      type:
        v: date
      required:
        v: false
    item:
      link id:
        v: nme3.3.5.3
      text:
        v: Description:
      type:
        v: text
      required:
        v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.6
    text:
      v: Unanticipated Problem Involving Risk to Participants or Others
    type:
      v: boolean
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: nme3.3.6_help
      text:
        v: Indicator if problem Involved risk to participants or others
      type:
        v: display

v: help

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

v: drop-down

v: Drop down

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: check-box
display:
  v: Check-box

v: Check-box

CodeableConcept
coding:
  system:
    v: http://hl7.org/fhir/questionnaire-item-control
  code:
    v: help
  display:
    v: Help-Button
text:
  v: Help-Button

v: color:#425caf; font-size: 115%; font-weight:bold

url:
  v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
value: CodeableConcept
  coding:
    system:
      v: http://hl7.org/fhir/questionnaire-item-control
    code:
      v: help
    display:
      v: Help-Button
  text:
    v: Help-Button

v: nme3.3.5.1_help

v: Date new or increased risk first documented

v: display

url:
  v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
value: CodeableConcept
  coding:
    system:
      v: http://hl7.org/fhir/questionnaire-item-control
    code:
      v: help
    display:
      v: Help-Button
  text:
    v: Help-Button

v: nme3.3.5.2_help

v: Date new or increased risk discovered

v: display

url:
  v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
value: CodeableConcept
  coding:
    system:
      v: http://hl7.org/fhir/questionnaire-item-control
    code:
      v: help
    display:
      v: Help-Button
  text:
    v: Help-Button

v: nme3.3.5.3_help

v: Description of new or increased risk

v: display

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: check-box
display:
  v: Check-box

v: Check-box

CodeableConcept
coding:
  system:
    v: http://hl7.org/fhir/questionnaire-item-control
  code:
    v: help
  display:
    v: Help-Button
text:
  v: Help-Button

link id:
  v: nme3.3.7
text:
  v: Unanticipated Problem
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#425caf; font-size: 115%; font-weight:bold
type:
  v: group
enable when:
  question:
    v: nme3.3.6
  operator:
    v: =
  answer:
    v: true
required:
  v: false
item:
  link id:
    v: nme3.3.7.1
  text:
    v: Event date:
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.7.1_help
    text:
      v: Date event occurred
    type:
      v: display
item:
  link id:
    v: nme3.3.7.2
  text:
    v: Date event became aware to study team:
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.7.2_help
    text:
      v: Date site research team first became aware of unanticipated problem
    type:
      v: display
item:
  link id:
    v: nme3.3.7.3
  text:
    v: Event Summary:
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.7.3_help
    text:
      v: Summary description of unanticipated problem
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: nme3.3.7.4
  text:
    v: Was this event Unexpected?
  type:
    v: choice
  required:
    v: false
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.7.4_help
    text:
      v: Indicator if unanticipated problem was unexpected
    type:
      v: display
item:
  link id:
    v: nme3.3.7.5
  text:
    v: If yes, please explain:
  type:
    v: text
  enable when:
    question:
      v: nme3.3.7.4
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.7.5_help
    text:
      v: Explanation for why unanticipated problem was unexpected
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: nme3.3.7.6
  text:
    v: Was this event Related or Possibly Related to participation in the research?
  type:
    v: choice
  required:
    v: false
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.7.6_help
    text:
      v: Unanticipated problem associated with participation in the research study
    type:
      v: display
item:
  link id:
    v: nme3.3.7.7
  text:
    v: If yes, please explain:
  type:
    v: text

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

v: drop-down

v: Drop down

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

v: drop-down

v: Drop down

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

question:
  v: nme3.3.7.6
operator:
  v: =
answer: Coding
  system:
    v: http://terminology.hl7.org/CodeSystem/v2-0532
  code:
    v: Y

v: false

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: help
      display:
        v: Help-Button
    text:
      v: Help-Button
link id:
  v: nme3.3.7.7_help
text:
  v: Explanation for why unanticipated problem is associated with participation in this research
type:
  v: display

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: drop-down
      display:
        v: Drop down
    text:
      v: Drop down
link id:
  v: nme3.3.7.8
text:
  v: Does this event suggest that the research places participant(s) or others at a greater Risk of harm than was previously known?
type:
  v: choice
required:
  v: false
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
    display:
      v: Yes
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
      v: No
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: nme3.3.7.8_help
  text:
    v: Indicator if unanticipated problem increased risk of harm to participants
  type:
    v: display

v: help

v: Help-Button

link id:
  v: nme3.3.7.9
text:
  v: If yes, please explain:
type:
  v: text
enable when:
  question:
    v: nme3.3.7.8
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: nme3.3.7.9_help
  text:
    v: Explanation for why unanticipated problem is associated with increased risk of harm for research participants
  type:
    v: display

v: help

v: Help-Button

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: check-box
      display:
        v: Check-box
    text:
      v: Check-box
link id:
  v: nme3.3.8
text:
  v: Protocol Deviation (accidental or unintentional)
type:
  v: boolean
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: nme3.3.8_help
  text:
    v: Indicator protocol deviation was accidental or unintentional
  type:
    v: display

v: help

v: Help-Button

link id:
  v: nme3.3.9
text:
  v: Protocol Deviation (Non-Compliance)
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#425caf; font-size: 115%; font-weight:bold
type:
  v: group
enable when:
  question:
    v: nme3.3.8
  operator:
    v: =
  answer:
    v: true
required:
  v: false
item:
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    v: nme3.3.9.1
  text:
    v: Date:
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.9.1_help
    text:
      v: Date non-compliance first identified
    type:
      v: display
item:
  link id:
    v: nme3.3.9.2
  text:
    v: Date discovered:
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.9.2_help
    text:
      v: Date site research team first discovered non-compliance protocol deviation
    type:
      v: display
item:
  link id:
    v: nme3.3.9.3
  text:
    v: Description:
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.9.3_help
    text:
      v: Description of non-compliance protocol deviation
    type:
      v: display
item:
  link id:
    v: nme3.3.9.4
  text:
    v: Does the deviation involve any of the following? (Select all that apply)
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: nme3.3.9.4.1
    text:
      v: Failure to obtain informed consent when IRB deemed required
    type:
      v: boolean
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: nme3.3.9.4.1_help
      text:
        v: Informed consent not obtained when required by IRB
      type:
        v: display
  item:
    link id:
      v: nme3.3.9.4.2
    text:
      v: Modifying the protocol without IRB approval, except to avoid hazard to participants
    type:
      v: boolean
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: nme3.3.9.4.2_help
      text:
        v: Protocol modified without IRB approval
      type:
        v: display
  item:
    link id:
      v: nme3.3.9.4.3
    text:
      v: Conducting research prior to IRB approval, during an IRB suspension or after IRB approval ends
    type:
      v: boolean
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: nme3.3.9.4.3_help
      text:
        v: Conducting research without IRB approval
      type:
        v: display
  item:
    link id:
      v: nme3.3.9.4.4
    text:
      v: Explain any Checked items
    type:
      v: text
    enable when:
      question:
        v: nme3.3.9.4.1
      operator:
        v: =
      answer:
        v: true
    enable when:
      question:
        v: nme3.3.9.4.2
      operator:
        v: =
      answer:
        v: true
    enable when:
      question:
        v: nme3.3.9.4.3
      operator:
        v: =
      answer:
        v: true
    enable behavior:
      v: any
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: nme3.3.9.4.4_help
      text:
        v: Explanation for why protocol deviation category checked
      type:
        v: display
item:
  link id:
    v: nme3.3.9.5
  text:
    v: Was the deviation a substantive change from the protocol adversely affecting any of the following? (Select all that apply)
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: nme3.3.9.5.1
    text:
      v: The rights, welfare, or safety of the participants
    type:
      v: boolean
    required:
      v: false

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

CodeableConcept
coding:
  system:
    v: http://hl7.org/fhir/questionnaire-item-control
  code:
    v: help
  display:
    v: Help-Button
text:
  v: Help-Button

CodeableConcept
coding:
  system:
    v: http://hl7.org/fhir/questionnaire-item-control
  code:
    v: help
  display:
    v: Help-Button
text:
  v: Help-Button

CodeableConcept
coding:
  system:
    v: http://hl7.org/fhir/questionnaire-item-control
  code:
    v: help
  display:
    v: Help-Button
text:
  v: Help-Button

CodeableConcept
coding:
  system:
    v: http://hl7.org/fhir/questionnaire-item-control
  code:
    v: help
  display:
    v: Help-Button
text:
  v: Help-Button

link id:
  v: nme3.3.9.5.2
text:
  v: The integrity of the research area
type:
  v: boolean
required:
  v: false

link id:
  v: nme3.3.9.5.3
text:
  v: The participants' willingness to continue participation
type:
  v: boolean
required:
  v: false

link id:
  v: nme3.3.9.5.4
text:
  v: Explain any Checked items
type:
  v: text
enable when:
  question:
    v: nme3.3.9.5.1
  operator:
    v: =
  answer:
    v: true
enable when:
  question:
    v: nme3.3.9.5.2
  operator:
    v: =
  answer:
    v: true
enable when:
  question:
    v: nme3.3.9.5.3
  operator:
    v: =
  answer:
    v: true
enable behavior:
  v: any
required:
  v: false

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: check-box
      display:
        v: Check-box
    text:
      v: Check-box
link id:
  v: nme3.3.10
text:
  v: A breach of Confidentiality
type:
  v: boolean
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: nme3.3.10_help
  text:
    v: Indicator of breach of confidentiality
  type:
    v: display

v: help

v: Help-Button

link id:
  v: nme3.3.11
text:
  v: Breach of Confidentiality
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#425caf; font-size: 115%; font-weight:bold
type:
  v: group
enable when:
  question:
    v: nme3.3.10
  operator:
    v: =
  answer:
    v: true
required:
  v: false
item:
  link id:
    v: nme3.3.11.1
  text:
    v: Date breach occurred
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.11.1_help
    text:
      v: Date breach of confidentiality first documented
    type:
      v: display
item:
  link id:
    v: nme3.3.11.2
  text:
    v: Date discovered:
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.11.2_help
    text:
      v: Date site study team discovered breach of confidentiality
    type:
      v: display
item:
  link id:
    v: nme3.3.11.3
  text:
    v: Description:
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.11.3_help
    text:
      v: Breach of confidentiality description
    type:
      v: display

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: check-box
      display:
        v: Check-box
    text:
      v: Check-box
link id:
  v: nme3.3.12
text:
  v: Incarceration of a participant in a protocol not approved to enroll prisoners
type:
  v: boolean
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: nme3.3.12_help
  text:
    v: Indicator of a study participant incarcerated when the protocol is not approved for prisoner enrollment
  type:
    v: display

v: help

v: Help-Button

link id:
  v: nme3.3.13
text:
  v: Incarceration
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#425caf; font-size: 115%; font-weight:bold
type:
  v: group
enable when:
  question:
    v: nme3.3.12
  operator:
    v: =
  answer:
    v: true
required:
  v: false
item:
  link id:
    v: nme3.3.13.1
  text:
    v: Date:
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.13.1_help
    text:
      v: Date site first documented participant incarceration.
    type:
      v: display
item:
  link id:
    v: nme3.3.13.2
  text:
    v: Date incarceration was discovered:
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.13.2_help
    text:
      v: Data site study team discovered patient incarceration
    type:
      v: display
item:
  link id:
    v: nme3.3.13.3
  text:
    v: Description:
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.13.3_help
    text:
      v: Description of patient incarceration
    type:
      v: display

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: check-box
      display:
        v: Check-box
    text:
      v: Check-box
link id:
  v: nme3.3.14
text:
  v: Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team
type:
  v: boolean
required:
  v: false
repeats:
  v: false
read only:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: nme3.3.14_help
  text:
    v: Indicator if participant complaint of unexpected risks was not resolved by study team. Complaint information is related to study site.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: nme3.3.15
text:
  v: Participant Complaint
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#425caf; font-size: 115%; font-weight:bold
type:
  v: group
enable when:
  question:
    v: nme3.3.14
  operator:
    v: =
  answer:
    v: true
required:
  v: false
item:
  link id:
    v: nme3.3.15.1
  text:
    v: Complaint Date:
  type:
    v: date
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.15.1_help
    text:
      v: Date a participant complaint was first documented
    type:
      v: display
item:
  link id:
    v: nme3.3.15.2
  text:
    v: Date received:
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.15.2_help
    text:
      v: Date site personnel first received a participant complaint
    type:
      v: display
item:
  link id:
    v: nme3.3.15.3
  text:
    v: Description:
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.15.3_help
    text:
      v: Description of participant unexpected risk complaint
    type:
      v: display

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: check-box
      display:
        v: Check-box
    text:
      v: Check-box
link id:
  v: nme3.3.16
text:
  v: Other Type of Adverse Non-Medical Event
type:
  v: boolean
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: nme3.3.16_help
  text:
    v: Indicator for other type of Adverse Non-Medical Event
  type:
    v: display

v: help

v: Help-Button

link id:
  v: nme3.3.17
text:
  v: Other Type
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#425caf; font-size: 115%; font-weight:bold
type:
  v: group
enable when:
  question:
    v: nme3.3.16
  operator:
    v: =
  answer:
    v: true
required:
  v: false
item:
  link id:
    v: nme3.3.17.1
  text:
    v: Event date:
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.17.1_help
    text:
      v: Date event occurred
    type:
      v: display
item:
  link id:
    v: nme3.3.17.2
  text:
    v: Date study team became aware of event:
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.17.2_help
    text:
      v: Date site research team first became aware of the event
    type:
      v: display
item:
  link id:
    v: nme3.3.17.3
  text:
    v: Event Summary:
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.17.3_help
    text:
      v: Summary description of the event
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: nme3.3.17.4
  text:
    v: Was this Adverse Non-Medical Event Unexpected?
  type:
    v: choice
  required:
    v: false
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.17.4_help
    text:
      v: Indicator if event was unexpected
    type:
      v: display
item:
  link id:
    v: nme3.3.17.5
  text:
    v: If yes, please explain:
  type:
    v: text
  enable when:
    question:
      v: nme3.3.17.4
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.17.5_help
    text:
      v: Explanation for why event was unexpected
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: nme3.3.17.6
  text:
    v: Was this event Related or Possibly Related to participation in the research?
  type:
    v: choice
  required:
    v: false
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: nme3.3.17.6_help
    text:
      v: Adverse Non-Medical Event association with participation in the research study
    type:
      v: display
item:
  link id:
    v: nme3.3.17.7
  text:
    v: If yes, please explain:
  type:
    v: text

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

v: drop-down

v: Drop down

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

v: drop-down

v: Drop down

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: help
display:
  v: Help-Button

v: Help-Button

question:
  v: nme3.3.17.6
operator:
  v: =
answer: Coding
  system:
    v: http://terminology.hl7.org/CodeSystem/v2-0532
  code:
    v: Y

v: false

extension:
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link id:
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text:
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type:
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link id:
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item:
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        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
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item:
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  repeats:
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  read only:
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      display:
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v: help

v: Help-Button

v: drop-down

v: Drop down

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display:
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code:
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display:
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v: Help-Button

v: drop-down

v: Drop down

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code:
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display:
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v: Help-Button

system:
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code:
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display:
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v: Help-Button

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    text:
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link id:
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text:
  v: Other parties notified of non-medical adverse event (such as coordinating center, other study sites, FDA)
type:
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link id:
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text:
  v: List other notified parties
type:
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enable when:
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  operator:
    v: =
  answer: Coding
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    code:
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required:
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repeats:
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link id:
  v: nme5
text:
  v: Corrective and Preventative Action Plan
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type:
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required:
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item:
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item:
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    v: nme5.2a
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    v: If yes, provide determination:
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item:
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    v: If pending, describe status and interim findings, if any:
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      v: Describe status and any interim findings of the root cause analysis
    type:
      v: display
item:
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      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
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      text:
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    v: Was Corrective Action implemented?
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        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
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    text:
      v: Indicator if corrective action is implemented for non-medical adverse event
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item:
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    v: If Corrective Action was implemented or is pending, provide a summary:
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    v: text
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      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: pending
  enable behavior:
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v: drop-down

v: Drop down

system:
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code:
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display:
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v: Help-Button

system:
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code:
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display:
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v: Help-Button

system:
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code:
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display:
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v: Help-Button

v: drop-down

v: Drop down

system:
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code:
  v: help
display:
  v: Help-Button

v: Help-Button

v: false

extension:
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  value: CodeableConcept
    coding:
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      code:
        v: help
      display:
        v: Help-Button
    text:
      v: Help-Button
link id:
  v: nme5.4_help
text:
  v: Summary of corrective action implemented for non-medical adverse event. If still pending, provide a status of the corrective action plan
type:
  v: display

extension:
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    coding:
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      display:
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    text:
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link id:
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text:
  v: Was Preventitive Action implemented?
type:
  v: choice
required:
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answer option:
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    code:
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    display:
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answer option:
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    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
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    display:
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answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
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    display:
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item:
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      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
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  link id:
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  type:
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v: help

v: Help-Button

link id:
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text:
  v: If Preventitive Action was implemented or is pending, provide a summary:
type:
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enable when:
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  operator:
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    system:
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enable when:
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enable behavior:
  v: any
required:
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item:
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    v: Summary of preventative action implemented for non-medical adverse event. If still pending, provide status.
  type:
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v: help

v: Help-Button

link id:
  v: nme6
text:
  v: Study Protocol and Informed Consent
  extension:
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      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#274e90; font-size: 150%
type:
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required:
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item:
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      text:
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  text:
    v: Description of protocol and informed consent changes
  type:
    v: display
item:
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    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: nme6.1a
  text:
    v: Are changes required to the Study Protocol as a result of this report?
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    v: choice
  required:
    v: false
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
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      display:
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  answer option:
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      system:
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      code:
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      display:
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        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
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      v: Indicator if changes are required in study protocol resulting from the non-medical adverse event report
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
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  extension:
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      v: http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation
    value:
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  link id:
    v: nme6.1b
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    v: Reason(s) why changes are not required in the Study Protocol:
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  enable when:
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      system:
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      display:
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      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
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      display:
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      system:
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      code:
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item:
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      code:
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      system:
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      code:
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  required:
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        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
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      display:
        v: Yes
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
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v: help

v: Help-Button

v: drop-down

v: Drop down

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display:
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v: Help-Button

v: check-box

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display:
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v: drop-down

v: Drop down

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v: nme6.3a_help

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v: display

extension:
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    coding:
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      display:
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extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation
  value:
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link id:
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text:
  v: Reason(s) why changes are not required in the Informed Consent:
type:
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enable when:
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    display:
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  value: Coding
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      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
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link id:
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text:
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type:
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    system:
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    code:
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enable behavior:
  v: all
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
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  link id:
    v: nme6.4_help
  text:
    v: Justification for decision not to change informed consent based upon non-medical adverse event report
  type:
    v: display

v: help

v: Help-Button

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: drop-down
      display:
        v: Drop down
    text:
      v: Drop down
link id:
  v: nme6.5
text:
  v: Are notifications or re-consenting of participants required as a result of changes in Study Protocol or Informed Consent?
type:
  v: choice
enable when:
  question:
    v: nme6.1a
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
enable when:
  question:
    v: nme6.3a
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
enable behavior:
  v: any
required:
  v: false
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
    display:
      v: Yes
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
      v: No
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: nme6.5_help
  text:
    v: Indicator if notification or reconsenting of participants is required due to changes in Study Protocol or Informed Consent
  type:
    v: display

v: help

v: Help-Button

link id:
  v: nme6.6
text:
  v: If yes, detail how the notification and/or re-consent will occur:
type:
  v: text
enable when:
  question:
    v: nme6.5
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
enable behavior:
  v: all
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: nme6.6_help
  text:
    v: Description of how notification or re-consent will occur
  type:
    v: display

v: help

v: Help-Button

link id:
  v: nme6.7
text:
  v: If no, justify your decision to not notify (re-consent) participants:
type:
  v: text
enable when:
  question:
    v: nme6.5
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
enable behavior:
  v: all
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: nme6.7_help
  text:
    v: Rationale for not notifying (re-consenting) study participants
  type:
    v: display

v: help

v: Help-Button

link id:
  v: nme11
text:
  v: Optional Attachments
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#274e90; font-size: 150%
type:
  v: group
required:
  v: false
repeats:
  v: true
item:
  link id:
    v: nme11.1
  text:
    v: Describe the file that is being attached (optional)
  type:
    v: string
item:
  link id:
    v: nme11.2
  text:
    v: Attachment
  type:
    v: attachment
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: nme11_help
  text:
    v: Attachments related to the Adverse Non-Medical Event can be included here.
  type:
    v: display

v: help

v: Help-Button

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
  value:
    v: true
link id:
  v: ADMIN00
text:
  v: Administrative Use Only
type:
  v: group
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
    value:
      v: true
  link id:
    v: ADMIN01
  text:
    v: Link ID prefix
  type:
    v: string
  required:
    v: false
  initial:
    value:
      v: nme
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
    value:
      v: true
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value
  link id:
    v: ADMIN02
  text:
    v: Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any
  type:
    v: string
  required:
    v: false
  initial:
    value:
      v: temporarily unavailable
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
    value:
      v: true
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value
  link id:
    v: ADMIN03
  text:
    v: ID of the Research Study FHIR Resource associated with the study Questionnaire Responses
  type:
    v: string
  required:
    v: false
  initial:
    value:
      v: temporarily unavailable
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
    value:
      v: true
  link id:
    v: ADMIN04
  text:
    v: Questionnaire Response ID of the local considerations Questionnaire Response, if any
  type:
    v: string
  required:
    v: false