sirb-adverse-event-questionnaire-populate
type: Questionnaire
node role: treeRoot
id:
  v: sirb-adverse-event-questionnaire-populate
text:
  status:
    v: generated
  div: Structure LinkId Text Cardinality Type Flags Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> AE_Questionnaire Questionnaire http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire-populate#1.0.0 mae1 Research Study 0..1 group mae1.1 Study Title 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value mae1.1_help Short title of the study, the same title listed on the Informed Consent 0..1 display mae1.2 IRB Protocol Number 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value mae1.2_help Number assigned by IRB; this number is the same as that on the Consent Form 0..1 display mae1.3 Study Type 0..1 choice Options: 2 options Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.4').answer.valueCoding mae1.3_help Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional) 0..1 display mae1.4 Does this protocol require an FDA exemption? 0..1 choice Options: 2 options Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.1').answer.valueCoding mae1.4_help Indicator for use of FDA regulated product 0..1 display mae1.5 Is an IND or IDE being used in this study? 0..1 choice Options: 2 options Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.2').answer.valueCoding mae1.5_help Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used? 0..1 display mae1.6 Select whether Investigational New Drug (IND) or Investigational Device Exemption (IDE): 0..1 choice Enable When: mae1.5 = Yes (expandedYes-NoIndicator#Y) Options: 2 options Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.4').answer.valueCoding mae1.7 IND/IDE Number 0..1 string Enable When: mae1.5 = Yes (expandedYes-NoIndicator#Y) Expressions: Initial Value: …
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 = 'mae4.1.7').answer.valueCoding.code
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: relying site where AE occurred
    name:
      v: relyingSiteForForm
    language:
      v: text/fhirpath
    expression:
      v: %resource.descendants().where(linkId = 'mae4.1.1').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 = 'mae4.9.1').answer.valueCoding.code
url:
  v: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire-populate
version:
  v: 1.0.0
name:
  v: AE_Questionnaire
title:
  v: Adverse Medical Event Questionnaire
status:
  v: draft
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: mae1
  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: mae1.1
    text:
      v: Study Title
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: mae1.1_help
      text:
        v: Short title of the study, the same title listed on 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: mae1.2
    text:
      v: IRB Protocol Number
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: mae1.2_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
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    link id:
      v: mae1.3
    text:
      v: Study Type
    type:
      v: choice
    required:
      v: false
    answer option:
      value: Coding
    answer option:
      value: Coding
    item:
      extension:
        value: CodeableConcept
      link id:
        v: mae1.3_help
      text:
        v: Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)
      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: text/fhirpath

v: %lookupInitiateStudy.descendants().where(linkId = 'in1.4').answer.valueCoding

v: INT

v: Interventional

v: OBS

v: Observational

CodeableConcept
coding:
  system:
    v: http://hl7.org/fhir/questionnaire-item-control
  code:
    v: help
  display:
    v: Help-Button
text:
  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
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 = 'in9.1').answer.valueCoding
link id:
  v: mae1.4
text:
  v: Does this protocol require an FDA exemption?
type:
  v: choice
required:
  v: false
repeats:
  v: false
read only:
  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: mae1.4_help
  text:
    v: Indicator for use of FDA regulated product
  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
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 = 'in9.2').answer.valueCoding
link id:
  v: mae1.5
text:
  v: Is an IND or IDE being used in this study?
type:
  v: choice
required:
  v: false
repeats:
  v: false
read only:
  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: mae1.5_help
  text:
    v: Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?
  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
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 = 'in9.4').answer.valueCoding
link id:
  v: mae1.6
text:
  v: Select whether Investigational New Drug (IND) or Investigational Device Exemption (IDE):
type:
  v: choice
enable when:
  question:
    v: mae1.5
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
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: IND
    display:
      v: IND
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: IDE
    display:
      v: IDE

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 = 'in9.3').answer.value
link id:
  v: mae1.7
text:
  v: IND/IDE Number
type:
  v: string
enable when:
  question:
    v: mae1.5
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
required:
  v: false

link id:
  v: mae4
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: mae4.1
  text:
    v: Where Adverse 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: mae4.1.7
    text:
      v: Did the Adverse 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: mae4.1.7_help
      text:
        v: This question and its answer will not print on the Adverse Medical Event Form but are necessary for the form logic. Select "Yes" if the Adverse 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/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_mae4.1.1
    text:
      v: External Data For linkId mae4.1.1
    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: mae4.1.1
    text:
      v: If the Adverse Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the the relying institution and relying site principal investigator details below.
    type:
      v: choice
    enable when:
      question:
        v: mae4.1.7
      operator:
        v: =
      answer: Coding
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: mae4.1.1_help
      text:
        v: This question and its answer will not print on the Adverse 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:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: mae4.1.2
    text:
      v: Name of organization/site where the event occurred
    type:
      v: string
    enable when:
      question:
        v: mae4.1.7
      operator:
        v: exists
      answer:
        v: true
    required:
      v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae4.1_help
    text:
      v: Location where Adverse Medical Event occurred. Adverse Medical Event is any untoward medical occurrence associated with a participant in research, whether or not associated with the participant's activities in the research.
    type:
      v: display
item:
  link id:
    v: mae4.7
  text:
    v: Site Principal Investigator
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style
      value:
        v: color:#2a623d; font-size: 125%
  type:
    v: group
  enable when:
    question:
      v: mae4.1.7
    operator:
      v: exists
    answer:
      v: true
  required:
    v: false
  repeats:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: mae4.7.1
    text:
      v: First Name
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: mae4.7.1_help
      text:
        v: First or given name of the principal investigator at site where Adverse Medical Event occurred
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: mae4.7.2
    text:
      v: Last Name

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

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_mae4.1.1').answer.value

v: N

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: 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)

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

v: Help-Button

v: text/fhirpath

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)

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: 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)

v: string

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: mae4.7.2_help
text:
  v: Surname or family name
type:
  v: display

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: mae4.7.5
text:
  v: Suffix
type:
  v: string
required:
  v: false
repeats:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae4.7.5_help
  text:
    v: Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.
  type:
    v: display

v: help

v: Help-Button

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: mae4.7.6
text:
  v: Degree(s)
type:
  v: string
required:
  v: false
repeats:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae4.7.6_help
  text:
    v: Professional and Academic degrees of the principal investigator at site where Adverse Medical Event occurred
  type:
    v: display

v: help

v: Help-Button

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: mae4.7.3
text:
  v: Phone
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: mae4.7.3_help
  text:
    v: 10-digit phone number, including area code
  type:
    v: display

v: help

v: Help-Button

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: mae4.7.4
text:
  v: Email
type:
  v: string
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: help
      display:
        v: Help-Button
    text:
      v: Help-Button
link id:
  v: mae4.7_help
text:
  v: Principal Investigator at site where Adverse Medical Event occurred
type:
  v: display

link id:
  v: mae4.9
text:
  v: Responsibility for Adverse 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: mae4.1.7
  operator:
    v: exists
  answer:
    v: true
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: mae4.9.1
  text:
    v: If the Adverse Medical Event occurred at a relying site, will the lead principal investigator site be recording the Adverse Non-Medical Event?
  type:
    v: choice
  enable when:
    question:
      v: mae4.1.7
    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: mae4.9.1_help
    text:
      v: Select "Yes" if the Adverse 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: mae4.9.2
  text:
    v: Name of organization/site which is recording the Adverse Medical event
  type:
    v: string
  enable when:
    question:
      v: mae4.1.7
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  enable when:
    question:
      v: mae4.9.1
    operator:
      v: exists
    answer:
      v: true
  enable behavior:
    v: any
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae4.9.2_help
    text:
      v: Location where adverse event is recorded
    type:
      v: display

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

link id:
  v: mae3
text:
  v: Primary Contact
  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: mae3_help
  text:
    v: Personnel completing the adverse medical event documentation at the lead or relying site
  type:
    v: display
item:
  link id:
    v: mae3.1
  text:
    v: First Name
  type:
    v: string
  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: mae3.1_help
    text:
      v: First or given name
    type:
      v: display
item:
  link id:
    v: mae3.2
  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: mae3.2_help
    text:
      v: Surname or family name
    type:
      v: display
item:
  link id:
    v: mae3.3
  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: mae3.3_help
    text:
      v: 10-digit phone number, including area code
    type:
      v: display
item:
  link id:
    v: mae3.4
  text:
    v: Email
  type:
    v: string
  required:
    v: false

v: help

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

link id:
  v: mae5
text:
  v: Participant Information
  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: mae5.1
  text:
    v: Patient ID
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae5.1_help
    text:
      v: Participant identifier from study case report form
    type:
      v: display
item:
  link id:
    v: mae5.2
  text:
    v: Age
  type:
    v: string
  required:
    v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: mae5.3
  text:
    v: Birth Sex
  type:
    v: choice
  required:
    v: false
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0001
      code:
        v: F
      display:
        v: Female
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0001
      code:
        v: M
      display:
        v: Male
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0001
      code:
        v: O
      display:
        v: Other
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0001
      code:
        v: U
      display:
        v: Unknown
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption
    value: Coding
      display:
        v: [lb]
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption
    value: Coding
      display:
        v: [kg]
  link id:
    v: mae5.4
  text:
    v: Weight
  type:
    v: quantity
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae5.4_help
    text:
      v: Select pounds or kilograms
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption
    value: Coding
      display:
        v: [in]
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption
    value: Coding
      display:
        v: [ft]
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption
    value: Coding
      display:
        v: [cm]
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption
    value: Coding
      display:
        v: [m]
  link id:
    v: mae5.5
  text:
    v: Height
  type:
    v: quantity
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae5.5_help
    text:
      v: Select inches, feet, centimeters, meters
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: mae5.6
  text:
    v: Ethnicity
  type:
    v: choice
  required:
    v: false
  repeats:
    v: false
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v3-Ethnicity
      code:
        v: 2135-2
      display:
        v: Hispanic or Latino
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v3-Ethnicity
      code:
        v: 2186-5
      display:
        v: Not Hispanic or Latino
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept

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

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

url:
  v: http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation
value:
  v: vertical

v: mae5.7

v: Race

v: choice

v: false

v: true

value: Coding
  system:
    v: http://terminology.hl7.org/CodeSystem/v3-Race
  code:
    v: 2028-9
  display:
    v: Asian

value: Coding
  system:
    v: http://terminology.hl7.org/CodeSystem/v3-Race
  code:
    v: 1002-5
  display:
    v: American Indian or Alaska Native

value: Coding
  system:
    v: http://terminology.hl7.org/CodeSystem/v3-Race
  code:
    v: 2054-5
  display:
    v: Black or African American

value: Coding
  system:
    v: http://terminology.hl7.org/CodeSystem/v3-Race
  code:
    v: 2076-8
  display:
    v: Native Hawaiian or Other Pacific Islander

value: Coding
  system:
    v: http://terminology.hl7.org/CodeSystem/v3-Race
  code:
    v: 2106-3
  display:
    v: White

link id:
  v: mae5.8
text:
  v: Which Arm/Cohort/treatment group was the participant assigned to (if known)?
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: mae5.8_help
  text:
    v: Patient's treatment strategy assignment, if known.
  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: mae5.9
text:
  v: Participant dosed or received study agent
type:
  v: choice
required:
  v: false
repeats:
  v: false
read only:
  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
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: NI
    display:
      v: No Information
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: NA
    display:
      v: not applicable
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae5.9_help
  text:
    v: Did the participant receive the investigational agent? If answer is unknown due to blinding, select No Information.
  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: mae5.10
text:
  v: What study agent was received:
type:
  v: choice
enable when:
  question:
    v: mae5.9
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
enable when:
  question:
    v: mae5.9
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: NI
enable behavior:
  v: any
required:
  v: false
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: SA
    display:
      v: Study Agent
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: PLACEBO
    display:
      v: Placebo
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: BSA
    display:
      v: Blinded Study Agent
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae5.10_help
  text:
    v: investigational agent or placebo or blinded study
  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: mae5.11
text:
  v: Were there any Protocol Deviations/Violations/Exceptions for this participant?
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: mae5.11_help
  text:
    v: Indicator if adverse medical event occurred with protocol deviation, violation, exception
  type:
    v: display

v: help

v: Help-Button

link id:
  v: mae5.12
text:
  v: Describe the Protocol Deviations/Violations/Exceptions
type:
  v: text
enable when:
  question:
    v: mae5.11
  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: mae5.12_help
  text:
    v: Description of protocol deviations, violations, or exceptions that occurred for this participant
  type:
    v: display

v: flyover

link id:
  v: mae6
text:
  v: Adverse Medical Event Information
  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: Drop down
  link id:
    v: mae6.1
  text:
    v: Submission Type
  type:
    v: choice
  required:
    v: false
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: INITIAL
      display:
        v: Initial
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: UPDATE
      display:
        v: Update
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae6.1_help
    text:
      v: Initial: the first time that the adverse medical event is reported or Update: update on a previously reported adverse medical event
    type:
      v: display
item:
  link id:
    v: mae6.2
  text:
    v: Start Date
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae6.2_help
    text:
      v: Date adverse event started
    type:
      v: display
item:
  link id:
    v: mae6.3
  text:
    v: Reported Date
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae6.3_help
    text:
      v: Date of this report
    type:
      v: display
item:
  link id:
    v: mae6.4
  text:
    v: Recorded Date
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae6.4_help
    text:
      v: Date this adverse event was first recorded
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: mae6.10
  text:
    v: Is the Adverse Medical Event Serious?
  type:
    v: choice
  required:
    v: false
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/adverse-event-seriousness
      code:
        v: serious
      display:
        v: Serious
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/adverse-event-seriousness
      code:
        v: non-serious
      display:
        v: Non-serious
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae6.10_help
    text:
      v: Event is considered serious and reportable to the FDA in the following outcomes: death, life-threatening, hospitalization, disability or permanent damage, congenital anaomaly/birth defect, need for required intervention to prevent permanent impairment or damage. See FDA Guidance: https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: mae6.9
  text:
    v: Severity
  type:
    v: choice
  required:
    v: false
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/adverse-event-severity
      code:
        v: mild
      display:
        v: Mild
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/adverse-event-severity
      code:
        v: moderate
      display:
        v: Moderate
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/adverse-event-severity
      code:
        v: severe
      display:
        v: Severe
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae6.9_help

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: 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

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

v: Physician assessment using sponsor defined categories

v: display

link id:
  v: mae6.40
text:
  v: Narrative of the Adverse Event:
type:
  v: text
enable when:
  question:
    v: mae6.10
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/adverse-event-seriousness
    code:
      v: serious
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae6.40_help
  text:
    v: Description of the SAE including chronological clinical presentation and evolution of the SAE and associated signs/symptoms. Serious Medical Event criteria are defined in the protocol.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: mae6.5
text:
  v: Medical Description of Adverse Event
type:
  v: text
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: mae6.5_help
  text:
    v: Diagnosis associated with adverse event. Any untoward medical occurrence associated with the use of a drug or device, whether or not considered related to the drug or device.
  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: mae6.6
text:
  v: Is the Adverse Medical event still ongoing?
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: mae6.6_help
  text:
    v: Indicator if the adverse event is still continuing or has been resolved.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: mae6.7
text:
  v: Stop Date
type:
  v: date
enable when:
  question:
    v: mae6.6
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae6.7_help
  text:
    v: Date that the event resolved
  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: mae6.8
text:
  v: Was the event expected?
type:
  v: choice
required:
  v: false
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0239
    code:
      v: Y
    display:
      v: Yes
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0239
    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: mae6.8_help
  text:
    v: Indicator that Adverse Medical Event was expected or not expected.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: mae6.11
text:
  v: Seriousness
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#2a623d; font-size: 125%
type:
  v: group
enable when:
  question:
    v: mae6.10
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/adverse-event-seriousness
    code:
      v: serious
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: mae6.11.1
  text:
    v: Seriousness
  type:
    v: choice
  enable when:
    question:
      v: mae6.10
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/adverse-event-seriousness
      code:
        v: serious
  required:
    v: false
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: ResultsInDeath
      display:
        v: Results in death
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: IsLifeThreatening
      display:
        v: Is Life-threatening
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: ResultsInHospitalization
      display:
        v: Requires or prolongs inpatient hospitalization
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: IsBirthDefect
      display:
        v: Is a congenital anomaly/birth defect
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: ResultsInDisability
      display:
        v: Results in persistent or significant disability/incapacity
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: RequiresPreventImpairment
      display:
        v: Requires intervention to prevent permanent impairment
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: Other
      display:
        v: Other
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae6.11.1_help
    text:
      v: An adverse event is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. DFR Title 21, Part 312, Subpart B, Sec. 312.32
    type:
      v: display
item:
  link id:
    v: mae6.11.2
  text:
    v: Other-specify
  type:
    v: text
  enable when:
    question:
      v: mae6.11.1
    operator:
      v: =
    answer: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: Other
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae6.11.2_help
    text:
      v: Describe other serious consequences or other medically important condition
    type:
      v: display

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

link id:
  v: mae6.12
text:
  v: What is the date Adverse Medical Event became serious?
type:
  v: date
enable when:
  question:
    v: mae6.10
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/adverse-event-seriousness
    code:
      v: serious
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae6.12_help
  text:
    v: Date adverse event was deemed as serious
  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: mae6.13
text:
  v: Outcome of Adverse Medical Event
type:
  v: choice
required:
  v: false
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: RCVRED
    display:
      v: recovered/resolved
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: RCVRING
    display:
      v: recovering/resolving
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: NRCVRED
    display:
      v: not recovered/not resolved/ongoing
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: SEQL
    display:
      v: recovered/resolved with sequelae
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: FATAL
    display:
      v: fatal
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: UNK
    display:
      v: unknown
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae6.13_help
  text:
    v: Participant's status after the adverse event
  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: mae6.14
text:
  v: Was autopsy performed?
type:
  v: choice
enable when:
  question:
    v: mae6.13
  operator:
    v: =
  answer: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: FATAL
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
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: UNK
    display:
      v: Unknown
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae6.14_help
  text:
    v: Indicator if participant was autopsied
  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: mae6.15
text:
  v: Relationship of Adverse Medical Event to Study Intervention
type:
  v: choice
required:
  v: false
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess
    code:
      v: certain
    display:
      v: Certain
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess
    code:
      v: probably-likely
    display:
      v: Probably/Likely
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess
    code:
      v: possible
    display:
      v: Possible
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess
    code:
      v: unlikely
    display:
      v: Unlikely
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess
    code:
      v: conditional-classified
    display:
      v: Conditional/Classified
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess
    code:
      v: unassessable-unclassifiable
    display:
      v: Unassessable/Unclassifiable

link id:
  v: mae6.16
text:
  v: Rationale for relationship with study intervention
type:
  v: text
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae6.16_help
  text:
    v: Explanation for relationship between study intervention and adverse event. You may also discuss why the AE appears to be unrelated or why it is not possible to determine the relationship.
  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: mae6.17
text:
  v: If applicable, what are possible alternate causes of the Adverse Medical Event?
type:
  v: choice
required:
  v: false
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: PRMYDIS
    display:
      v: Primary disease
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: STDYPRO
    display:
      v: Study Procedure
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: PRE
    display:
      v: Pre-existing condition
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: UNDERLYINGDIS
    display:
      v: Underlying disease
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: CONCMITMED
    display:
      v: Concomitant medication
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: OTHERCAUSE
    display:
      v: Other known or suspected cause
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae6.17_help
  text:
    v: Reason for possible alternative serious adverse event causes
  type:
    v: display

v: help

v: Help-Button

link id:
  v: mae6.18
text:
  v: Study Procedure-specify
type:
  v: text
enable when:
  question:
    v: mae6.17
  operator:
    v: =
  answer: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: STDYPRO
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae6.18_help
  text:
    v: Study procedure associated with SAE
  type:
    v: display

v: help

v: Help-Button

link id:
  v: mae6.19
text:
  v: Pre-existing condition-specify
type:
  v: text
enable when:
  question:
    v: mae6.17
  operator:
    v: =
  answer: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: PRE
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae6.19_help
  text:
    v: Pre-existing condition associated with SAE
  type:
    v: display

v: help

v: Help-Button

link id:
  v: mae6.20
text:
  v: Underlying disease-specify
type:
  v: text
enable when:
  question:
    v: mae6.17
  operator:
    v: =
  answer: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: UNDERLYINGDIS
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae6.20_help
  text:
    v: Underlying disease associated with SAE
  type:
    v: display

v: help

v: Help-Button

link id:
  v: mae6.21
text:
  v: Concomittant medication-specify
type:
  v: text
enable when:
  question:
    v: mae6.17
  operator:
    v: =
  answer: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: CONCMITMED
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae6.21_help
  text:
    v: Concomitant medication associated with SAE
  type:
    v: display

v: help

v: Help-Button

link id:
  v: mae6.22
text:
  v: Other known or suspected cause-specify
type:
  v: text
enable when:
  question:
    v: mae6.17
  operator:
    v: =
  answer: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: OTHERCAUSE
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae6.22_help
  text:
    v: Description of other causal reason associated with SAE
  type:
    v: display

v: help

v: Help-Button

link id:
  v: mae6.23
text:
  v: Action Taken
  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
      text:
        v: Drop down
  link id:
    v: mae6.23.1
  text:
    v: Action Taken Regarding Study Intervention
  type:
    v: choice
  required:
    v: false
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0251
      code:
        v: WP
      display:
        v: Product withdrawn permanently
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0251
      code:
        v: WT
      display:
        v: Product withdrawn temporarily
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0251
      code:
        v: DR
      display:
        v: Product dose or frequency of use reduced
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0251
      code:
        v: DI
      display:
        v: Product dose or frequency of use increased
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: NC
      display:
        v: Product dose or frequency of use not changed
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: UNK
      display:
        v: Unknown
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: NA
      display:
        v: Not applicable
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae6.23.1_help
    text:
      v: Changes to study intervention made after adverse event was detected
    type:
      v: display

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: drop-down
      display:
        v: Drop down
    text:
      v: Drop down
link id:
  v: mae6.24
text:
  v: If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate?
type:
  v: choice
required:
  v: false
repeats:
  v: false
read only:
  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
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: NA
    display:
      v: not applicable
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae6.24_help
  text:
    v: Adverse event diminished/abated after study intervention was discontinued, interrupted, or dose reduced (dechallenged)
  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: mae6.25
text:
  v: If study intervention was restarted (rechallenge) did AE recur?
type:
  v: choice
required:
  v: false
repeats:
  v: false
read only:
  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
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: NA
    display:
      v: not applicable
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae6.25_help
  text:
    v: Adverse event recurred when the study intervention was restarted
  type:
    v: display

v: help

v: Help-Button

link id:
  v: mae6.50
text:
  v: SAE Concomitant Medications, Treatments/Procedures and Tests
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#2a623d; font-size: 125%
type:
  v: group
enable when:
  question:
    v: mae6.10
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/adverse-event-seriousness
    code:
      v: serious
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: mae6.50.26
  text:
    v: Did the participant receive any relevant concomitant medications in response to the SAE?
  type:
    v: choice
  enable when:
    question:
      v: mae6.10
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/adverse-event-seriousness
      code:
        v: serious
  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:
  link id:
    v: mae6.50.28
  text:
    v: SAE Concomitant Medications
  type:
    v: group
  enable when:
    question:
      v: mae6.50.26
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  required:
    v: false
  repeats:
    v: true
  item:
    link id:
      v: mae6.50.28.1
    text:
      v: Medication Name
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: mae6.50.28.1_help
      text:
        v: Name of concomitant medication given to participant in response to SAE
      type:
        v: display
  item:
    link id:
      v: mae6.50.28.2
    text:
      v: Indication
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: mae6.50.28.2_help
      text:
        v: Indication for giving the concomitant medication to participant
      type:
        v: display
  item:
    link id:
      v: mae6.50.28.3
    text:
      v: Start Date
    type:
      v: date
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: mae6.50.28.3_help
      text:
        v: Start date for the concomitant medication given to participant
      type:
        v: display
  item:
    link id:
      v: mae6.50.28.4
    text:
      v: Stop Date
    type:
      v: date
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: mae6.50.28.4_help
      text:
        v: Stop date for the concomitant medication given to the participant
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae6.50.28.5
    text:
      v: Ongoing
    type:
      v: choice
    required:
      v: false
    answer option:
      value: Coding
    answer option:
      value: Coding
    item:
      extension:
        value: CodeableConcept
      link id:
        v: mae6.50.28.5_help
      text:
        v: Is concomitant medication administration for participant ongoing?
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae6.50.28_help
    text:
      v: Concomitant medication associated with SAE
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down

v: drop-down

v: Drop down

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

system:
  v: http://hl7.org/fhir/questionnaire-item-control
code:
  v: gtable
display:
  v: Group Table

v: Group Table

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: help
display:
  v: Help-Button

v: Help-Button

v: drop-down

v: Drop down

v: mae6.50.29

v: Did the participant receive any treatments/procedures in response to the SAE?

v: choice

question:
  v: mae6.10
operator:
  v: =
answer: Coding
  system:
    v: http://terminology.hl7.org/CodeSystem/adverse-event-seriousness
  code:
    v: serious

v: false

value: Coding
  system:
    v: http://terminology.hl7.org/CodeSystem/v2-0532
  code:
    v: Y
  display:
    v: Yes

value: Coding
  system:
    v: http://terminology.hl7.org/CodeSystem/v2-0532
  code:
    v: N
  display:
    v: No

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: mae6.50.29_help
text:
  v: Treatments/procedures administered in response to SAE
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: gtable
      display:
        v: Group Table
    text:
      v: Group Table
link id:
  v: mae6.50.30
text:
  v: SAE Treatments/Procedures
type:
  v: group
enable when:
  question:
    v: mae6.50.29
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
required:
  v: false
repeats:
  v: true
item:
  link id:
    v: mae6.50.30.1
  text:
    v: Treatment/Procedure
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae6.50.30.1_help
    text:
      v: Name of SAE treatment/procedure participant received
    type:
      v: display
item:
  link id:
    v: mae6.50.30.2
  text:
    v: Start Date
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae6.50.30.2_help
    text:
      v: Start date for SAE treatment/procedure participant received
    type:
      v: display
item:
  link id:
    v: mae6.50.30.3
  text:
    v: Stop Date
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: mae6.50.30.3_help
    text:
      v: Stop date for SAE treatment/procedure participant received
    type:
      v: display
item:
  link id:
    v: mae6.50.30.4
  text:
    v: Ongoing
  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: mae6.50.30.4_help
    text:
      v: Is the SAE treatment/procedure for the participant ongoing
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: mae6.50.30_help
  text:
    v: SAE treatment/procedure participant received
  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

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: mae6.50.37
text:
  v: Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?
type:
  v: choice
enable when:
  question:
    v: mae6.10
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/adverse-event-seriousness
    code:
      v: serious
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: mae6.50.37_help
  text:
    v: Were any laboratory or diagnostic tests administered to the participant in response to the SAE?
  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: gtable
      display:
        v: Group Table
    text:
      v: Group Table
link id:
  v: mae6.50.38
text:
  v: SAE Laboratory or Diagnostic Tests
type:
  v: group
enable when:
  question:
    v: mae6.50.37
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
required:
  v: false
repeats:
  v: true
item:
  link id:
    v: mae6.50.38.1
  text:
    v: Lab/Diagnostic Test
  type:
    v: string
  required:
    v: false
item:
  link id:
    v: mae6.50.38.2
  text:
    v: Date
  type:
    v: date
  required:
    v: false
item:
  link id:
    v: mae6.50.38.3
  text:
    v: Result
  type:
    v: string
  required:
    v: false
item:
  link id:
    v: mae6.50.38.4
  text:
    v: Low Range
  type:
    v: string
  required:
    v: false
item:
  link id:
    v: mae6.50.38.5
  text:
    v: High Range
  type:
    v: string
  required:
    v: false
item:
  link id:
    v: mae6.50.38.6
  text:
    v: Comments
  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: mae6.50.38_help
  text:
    v: Laboratory or diagnostic tests obtained in response to SAE
  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: help
      display:
        v: Help-Button
    text:
      v: Help-Button
link id:
  v: mae6_help
text:
  v: An event that (1) is more likely than not related to study activities; and (2) represents a new risk; and (3) is unanticipated. In addition, an expected event that is occurring at a frequency or intensity greater than originally anticipated.
type:
  v: display

link id:
  v: mae11
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: mae11.1
  text:
    v: Describe the file that is being attached (optional)
  type:
    v: string
item:
  link id:
    v: mae11.2
  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: mae11_help
  text:
    v: Attachments related to the Adverse Event Report 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: mae
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