sirb-consent-questionnaire-populate
type: Questionnaire
node role: treeRoot
id:
  v: sirb-consent-questionnaire-populate
text:
  status:
    v: generated
  div: Structure LinkId Text Cardinality Type Flags Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> Consent_Questionnaire Questionnaire http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire-populate#1.0.0 c1 Research Study 0..1 group c1.1 Study Title 0..1 text Expressions: Initial Value: %lookupInitiateStudy.item.item.where(linkId = 'in1.2').answer.value c1.1_help Short Title of the Research Study 0..1 display c1.2 IRB Protocol Number 0..1 string Expressions: Initial Value: %lookupInitiateStudy.item.item.where(linkId = 'in1.3').answer.value c38 Study Site 0..1 group ExternalDataFor_c38.1 External Data For linkId c38.1 0..* open-choice Expressions: Initial Value: %lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value c38.1 Select the relying site that this consent form pertains to, in order to pre-populate the relying institution and relying site principal investigator details below. 0..1 choice c38.1_help This question and its answer will not print on the Consent Form but are necessary for the form logic. If you do not want pre-population to occur, leave this question blank and manually fill in the relying institution and relying site principal investigator details. 0..1 display c38.2 Is this relying site also functioning as the lead site for the overall study with the lead PI for the overall study as the site PI? 1..1 choice Options: 2 options Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.5.4').answer.valueCoding c38.2_help This question and its answer will not print on the Consent Form but are necessary for the form logic. 0..1 display c40 Study Site Principal Investigator and Study Site 0..1 group c40.1 Multi-site statement 0..1 text Initial Value: string = This research study is part of a multi-site research study. There are other institutions with participants this study.…
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: site that the consent form pertains to
    name:
      v: relyingSiteForForm
    language:
      v: text/fhirpath
    expression:
      v: %resource.descendants().where(linkId = 'c38.1').answer.valueCoding.display
url:
  v: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire-populate
version:
  v: 1.0.0
name:
  v: Consent_Questionnaire
title:
  v: Consent 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: c1
  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: c1.1
    text:
      v: Study Title
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c1.1_help
      text:
        v: Short Title of the Research Study
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    link id:
      v: c1.2
    text:
      v: IRB Protocol Number
    type:
      v: string
    required:
      v: false
item:
  link id:
    v: c38
  text:
    v: Study 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:
    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_c38.1
    text:
      v: External Data For linkId c38.1
    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: c38.1
    text:
      v: Select the relying site that this consent form pertains to, in order to pre-populate the relying institution and relying site principal investigator details below.
    type:
      v: choice
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c38.1_help

v: text/fhirpath

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

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_c38.1').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: This question and its answer will not print on the Consent 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.

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
extension:
  url:
    v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.5.4').answer.valueCoding
link id:
  v: c38.2
text:
  v: Is this relying site also functioning as the lead site for the overall study with the lead PI for the overall study as the site PI?
type:
  v: choice
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
      text:
        v: Help-Button
  link id:
    v: c38.2_help
  text:
    v: This question and its answer will not print on the Consent Form but are necessary for the form logic.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: c40
text:
  v: Study Site Principal Investigator and Study 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: c40.1
  text:
    v: Multi-site statement
  type:
    v: text
  required:
    v: false
  initial:
    value:
      v: This research study is part of a multi-site research study. There are other institutions with participants this study. Later in this consent form, more details about the number of participants and sites will be discussed.
item:
  link id:
    v: c40.2
  text:
    v: Statement for Consent Form at Lead PI Site
  type:
    v: text
  enable when:
    question:
      v: c38.2
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  required:
    v: false
  initial:
    value:
      v: In multi-site studies, there is a lead institution that is responsible for the overall coordination of the study. The lead institution has a lead Principal Investigator who is responsible for the overall conduct of the study. The site where you are participating in the study is the lead or main site. The lead study site is responsible for all study activities for the overall study. The principal investigator(PI) is responsible for the conduct of the study. The PI for your study is the lead principal investigator, responsible for the overall study.
item:
  link id:
    v: c40.3
  text:
    v: Statement for Consent Form at Relying Site (not Lead PI Site)
  type:
    v: text
  enable when:
    question:
      v: c38.2
    operator:
      v: !=
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  required:
    v: false
  initial:
    value:
      v: This consent form describes your involvement in research at the study site listed below. The site principal investigator (PI) is responsible for the conduct of the study at this site.
item:
  link id:
    v: c40.5
  text:
    v: Principal Investigator at Study Site
    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/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: c40.5.2
    text:
      v: First Name
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c40.5.2_help
      text:
        v: First or given name of the relying site PI
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: c40.5.1
    text:
      v: Last Name
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c40.5.1_help
      text:
        v: Surname or family name of the relying site PI
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: c40.5.6
    text:
      v: Suffix
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c40.5.6_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
    link id:
      v: c40.5.3
    text:
      v: Degree(s)
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c40.5.3_help
      text:
        v: Professional and Academic degrees of the relying site PI
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: c40.5.4
    text:
      v: Associated Institution
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c40.5.4_help
      text:
        v: Relying site PI's Academic or Professional Institution
      type:
        v: display
  item:
    link id:
      v: c40.5.8
    text:
      v: Contact Information
    type:
      v: group
    required:
      v: false

v: text/fhirpath

v: %lookupInitiateStudy.item.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: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.2').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.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.3').answer.value

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

v: text/fhirpath

v: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.4').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.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value

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

extension:
  url:
    v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value
link id:
  v: c40.5.8.20
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: c40.5.8.20_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: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value
link id:
  v: c40.5.8.21
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: c40.5.8_help
text:
  v: Information on how to contact the Site PI.
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: help
      display:
        v: Help-Button
    text:
      v: Help-Button
link id:
  v: c40.5_help
text:
  v: Principal Investigator at Relying Site conducting the study, responsible for the conduct of the study at the relying site
type:
  v: display

link id:
  v: c40.9
text:
  v: Study Site Institution
  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/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value
  link id:
    v: c40.9.1
  text:
    v: Institution Name
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c40.9.1_help
    text:
      v: Public or private entity conducting the study- where the participant will go or call
    type:
      v: display
item:
  link id:
    v: c40.9.2
  text:
    v: Address
  type:
    v: group
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: c40.9.2.10
    text:
      v: Street Address
    type:
      v: string
    required:
      v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: c40.9.2.11
    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
    link id:
      v: c40.9.2.12
    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
    link id:
      v: c40.9.2.13
    text:
      v: Zip Code
    type:
      v: string
    required:
      v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: c40.9.2.14
    text:
      v: Country
    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: c40.9_help
  text:
    v: Information about institution for the site where study will be conducted
  type:
    v: display

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

v: Help-Button

v: text/fhirpath

v: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.1').answer.value

v: text/fhirpath

v: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.2').answer.value

v: text/fhirpath

v: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.3').answer.value

v: text/fhirpath

v: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.4').answer.value

v: text/fhirpath

v: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.5').answer.value

v: help

v: Help-Button

link id:
  v: c49
text:
  v: Lead Principal Investigator and Lead Principal Investigator Site
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#274e90; font-size: 150%
type:
  v: group
enable when:
  question:
    v: c38.2
  operator:
    v: !=
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
required:
  v: false
item:
  link id:
    v: c49.1
  text:
    v: Statement about Lead PI and Lead PI Site for Consent Form at Relying Site
  type:
    v: text
  enable when:
    question:
      v: c38.2
    operator:
      v: !=
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  required:
    v: false
  initial:
    value:
      v: In multi-site studies, there is a lead institution that is responsible for the overall coordination of the study. The lead institution has a lead Principal Investigator who is responsible for the overall conduct of the study. The lead site and lead Principal Investigator are listed here for your information.
item:
  link id:
    v: c49.2
  text:
    v: Lead Principal Investigator
    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/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    link id:
      v: c49.2.2
    text:
      v: First Name
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c49.2.2_help
      text:
        v: First or given name of the lead PI
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    link id:
      v: c49.2.1
    text:
      v: Last Name
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c49.2.1_help
      text:
        v: Surname or family name of the lead PI
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    link id:
      v: c49.2.6
    text:
      v: Suffix
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c49.2.6_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-initialExpression
      value: Expression
    link id:
      v: c49.2.3
    text:
      v: Degree(s)
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c49.2.3_help
      text:
        v: Professional and Academic degrees of the lead PI
      type:
        v: display
  item:
    link id:
      v: c49.2.5
    text:
      v: Contact Information
    type:
      v: group
    required:
      v: false
    item:
      extension:
        value: Expression
      link id:
        v: c49.2.5.20
      text:
        v: Phone
      type:
        v: string
      required:
        v: false
    item:
      extension:
        value: Expression
      link id:
        v: c49.2.5.21
      text:
        v: Email
      type:
        v: string
      required:
        v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c49.2.5_help
      text:
        v: Information on how to contact the Lead PI.
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c49.2_help
    text:
      v: Person(s) designated as the lead PI(s) for the multisite clinical trial; has the appropriate level of authority and responsibility to direct the research being conducted at all sites participating in the clinical trial.
    type:
      v: display
item:
  link id:
    v: c49.5

v: text/fhirpath

v: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').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: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').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 = 'in7.3.3').answer.value

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

v: text/fhirpath

v: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value

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

Expression
language:
  v: text/fhirpath
expression:
  v: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value

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: c49.2.5.20_help

v: 10-digit phone number, including area code

v: display

Expression
language:
  v: text/fhirpath
expression:
  v: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').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: help
display:
  v: Help-Button

v: Help-Button

v: Lead Principal Investigator Institution
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/rendering-style
  value:
    v: color:#2a623d; font-size: 125%

v: group

question:
  v: c38.2
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/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value
link id:
  v: c49.5.1
text:
  v: Name
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: c49.5.1_help
  text:
    v: Public or private entity associated with the lead principal investigator conducting the overall study.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: c49.5.2
text:
  v: Address
type:
  v: group
required:
  v: false
item:
  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 = 'in7.3.7.1').answer.value
  link id:
    v: c49.5.2.10
  text:
    v: Street Address
  type:
    v: string
  required:
    v: false
item:
  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 = 'in7.3.7.2').answer.value
  link id:
    v: c49.5.2.11
  text:
    v: City
  type:
    v: string
  required:
    v: false
item:
  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 = 'in7.3.7.3').answer.value
  link id:
    v: c49.5.2.12
  text:
    v: State
  type:
    v: string
  required:
    v: false
item:
  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 = 'in7.3.7.4').answer.value
  link id:
    v: c49.5.2.13
  text:
    v: Zip Code
  type:
    v: string
  required:
    v: false
item:
  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 = 'in7.3.7.5').answer.value
  link id:
    v: c49.5.2.14
  text:
    v: Country
  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: c49.5_help
text:
  v: Information about Lead Institution
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: c4
text:
  v: Sponsor or Funding Source
  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: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: %lookupInitiateStudy.item.where(repeat(item).where(linkId = 'in5.1' and answer.value.code = 'SFS')).repeat(item).where(linkId = 'in5.2').answer.value
  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_c4.1
  text:
    v: External Data For linkId c4.1
  type:
    v: open-choice
  required:
    v: false
  repeats:
    v: true
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-answerExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: %resource.repeat(item).where(linkId = 'ExternalDataFor_c4.1').answer.value
  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: c4.1
  text:
    v: Sponsor Name
  type:
    v: open-choice
  required:
    v: false
  repeats:
    v: true
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c4.1_help
    text:
      v: Entity financially supporting the research
    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

link id:
  v: c5
text:
  v: Sponsor Detail
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: c5_help
  text:
    v: Any additional relevant information about the sponsor(s)
  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: c6
text:
  v: Is this consent an eConsent?
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: c6_help
  text:
    v: Consent that is obtained electronically
  type:
    v: display

v: help

v: Help-Button

link id:
  v: c7
text:
  v: Summary Text
  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: c7.1
  text:
    v: Summary Text Statement
  type:
    v: text
  required:
    v: true
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c7.1_help
    text:
      v: Describes the basic purpose, procedures and reasons behind the research in easily understood prose
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: c7_help
  text:
    v: Section header for the mandated text describing the basic purpose, procedures and reasons for the study.
  type:
    v: display

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: c8
text:
  v: Introduction and Statement of Research
  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: c8.1
  text:
    v: About Consent Form
  type:
    v: text
  required:
    v: false
  initial:
    value:
      v: This consent form describes a research study, what you may expect if you decide to take part and important information to help you make your decision. Please read this form carefully and ask questions about anything that is not clear before you agree to participate. We encourage you to discuss this research with family or friends before consenting to participate.
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: c8_help
  text:
    v: Introductory Paragraph to the participant. Includes statement of research and explanation of the consent process.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: c9
text:
  v: Purpose
  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: c9.1
  text:
    v: Reason for Research
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c9.1_help
    text:
      v: Explanation about why the study is being conducted
    type:
      v: display
item:
  link id:
    v: c9.2
  text:
    v: Interactions with others
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c9.2_help
    text:
      v: Statement of whom the participant can anticipate interacting with during study participation
    type:
      v: display
item:
  link id:
    v: c9.3
  text:
    v: Invited Participants
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c9.3_help
    text:
      v: High level information about what participating in the study will entail for the participant
    type:
      v: display
item:
  link id:
    v: c9.4
  text:
    v: Total expected study enrollment
  type:
    v: integer
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c9.4_help
    text:
      v: The total number of people targeted for enrollment in the multi-site study
    type:
      v: display
item:
  link id:
    v: c9.5
  text:
    v: Additional Enrollment Text
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c9.5_help
    text:
      v: Additional field for including miscellaneous enrollment information. May include information about total enrollment from the relying site
    type:
      v: display
item:
  link id:
    v: c9.6
  text:
    v: What is involved in the study?
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c9.6_help
    text:
      v: High level information about what participating in the study will entail for the participant.
    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

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

v: Help-Button

link id:
  v: c10
text:
  v: Assessments
  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: Group Table
  link id:
    v: c10.1
  text:
    v: Assessment List
    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: true
  item:
    link id:
      v: c10.1.1
    text:
      v: Name of the Assessment
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c10.1.1_help
      text:
        v: Short name of the assessment
      type:
        v: display
  item:
    link id:
      v: c10.1.2
    text:
      v: Description of Assessment
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c10.1.2_help
      text:
        v: Short description of the assessment
      type:
        v: display
item:
  link id:
    v: c10.31
  type:
    v: display
item:
  link id:
    v: c10.2
  text:
    v: Assessment Supplemental Text
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c10.2_help
    text:
      v: Additional text to provide additional context about the assessments collected
    type:
      v: display
item:
  link id:
    v: c10.32
  type:
    v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: c10.3
  text:
    v: Do you want to upload the "Assessment List" table instead of typing the assessments directly into this questionnaire?
  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
    initial selected:
      v: true
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c10.3_help
    text:
      v: If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Assessment List" table in the questionnaire.
    type:
      v: display
item:
  link id:
    v: c10.4
  text:
    v: Assessment List Attachment(s)
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style
      value:
        v: color:#2a623d; font-size: 125%
  type:
    v: group
  enable when:
    question:
      v: c10.3
    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: c10.4.1
    text:
      v: Describe the file that is being attached (optional)
    type:
      v: string
    required:
      v: false
  item:
    link id:
      v: c10.4.2
    text:
      v: Upload attachment(s) here.
    type:
      v: attachment
item:
  link id:
    v: c10.33
  type:
    v: display

v: gtable

v: Group Table

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: 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

link id:
  v: c11
text:
  v: Visits and Procedures
  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: c11.1
  text:
    v: Visit Introductory Text
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c11.1_help
    text:
      v: Introductory Text to include prior to the visit table to introduce what the tables contain and explain any additional detail or information about the visit schedule.
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Group Table
  link id:
    v: c11.2
  text:
    v: Visit List
    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: true
  item:
    link id:
      v: c11.2.1
    text:
      v: Visit Type
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c11.2.1_help
      text:
        v: Unique visit type, defined by the procedures which are completed within that visit. E.g. Screening, Baseline, Followup, Final
      type:
        v: display
  item:
    link id:
      v: c11.2.2
    text:
      v: Visit Description
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c11.2.2_help
      text:
        v: Description of Visit types, including what procedures it contains
      type:
        v: display
  item:
    link id:
      v: c11.2.3
    text:
      v: Visit Duration
    type:
      v: decimal
    required:
      v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c11.2.4
    text:
      v: Visit Duration Units
    type:
      v: choice
    required:
      v: false
    answer option:
      value: Coding
    answer option:
      value: Coding
    answer option:
      value: Coding
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c11.2.4_help
      text:
        v: Choices for visit duration units are minutes (min), hours (h) or days (d).
      type:
        v: display
  item:
    link id:
      v: c11.2.5
    text:
      v: Number of Visits
    type:
      v: integer
    required:
      v: false
item:
  link id:
    v: c11.31
  type:
    v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: c11.6
  text:
    v: Do you want to upload the "Visit List" table instead of typing the visits directly into this questionnaire?
  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
    initial selected:
      v: true
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c11.6_help
    text:
      v: If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Visit List" table in the questionnaire.
    type:
      v: display
item:
  link id:
    v: c11.7
  text:
    v: Visit List Attachment(s)
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style
      value:
        v: color:#2a623d; font-size: 125%
  type:
    v: group
  enable when:
    question:
      v: c11.6
    operator:
      v: =
    answer: Coding

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

v: Help-Button

v: gtable

v: Group Table

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: drop-down
display:
  v: Drop down

v: Drop down

v: min

v: min

v: h

v: h

v: d

v: d

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

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

v: false

v: true

link id:
  v: c11.7.1
text:
  v: Describe the file that is being attached (optional)
type:
  v: string
required:
  v: false

link id:
  v: c11.7.2
text:
  v: Upload attachment(s) here.
type:
  v: attachment

link id:
  v: c11.32
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: c11.3
text:
  v: Procedure List
  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: true
item:
  link id:
    v: c11.3.1
  text:
    v: Name of Procedure
  type:
    v: string
  required:
    v: false
item:
  link id:
    v: c11.3.2
  text:
    v: Common Term of Procedure
  type:
    v: string
  required:
    v: false
item:
  link id:
    v: c11.3.3
  text:
    v: Description of a Procedure
  type:
    v: text
  required:
    v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: c11.3.4
  text:
    v: Experimental Procedure Indicator
  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: Drop down
  link id:
    v: c11.3.5
  text:
    v: Research Indicator
  type:
    v: choice
  required:
    v: false
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: RES
      display:
        v: Research
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: STDCR
      display:
        v: Standard of Care
item:
  link id:
    v: c11.3.6
  text:
    v: Frequency
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c11.3.6_help
    text:
      v: Specify the procedure frequency and the applicable frequency units. For example, 4 times per year or 2 times per week.
    type:
      v: display
item:
  link id:
    v: c11.3.9
  text:
    v: Procedure Duration (minutes)
  type:
    v: integer
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c11.3.9_help
    text:
      v: Specify the procedure duration in minutes
    type:
      v: display

v: drop-down

v: Drop down

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: c11.33
type:
  v: display

link id:
  v: c11.4
text:
  v: Procedure Supplemental Text
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: c11.4_help
  text:
    v: Additional Text to include after the procedure table to provide the participant with any additional information needed about procedure schedule
  type:
    v: display

v: help

v: Help-Button

link id:
  v: c11.34
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: c11.9
text:
  v: Do you want to upload the "Procedure List" table instead of typing the procedures directly into this questionnaire?
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
  initial selected:
    v: true
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: c11.9_help
  text:
    v: If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Procedure List" table in the questionnaire.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: c11.10
text:
  v: Procedure List Attachment(s)
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#2a623d; font-size: 125%
type:
  v: group
enable when:
  question:
    v: c11.9
  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: c11.10.1
  text:
    v: Describe the file that is being attached (optional)
  type:
    v: string
  required:
    v: false
item:
  link id:
    v: c11.10.2
  text:
    v: Upload attachment(s) here.
  type:
    v: attachment

link id:
  v: c11.35
type:
  v: display

link id:
  v: c11.5
text:
  v: Total Duration of Study Participation
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: c11.5_help
  text:
    v: Time elapsed for a participant to be part of the study from initial enrollment to final discharge or completion
  type:
    v: display

v: help

v: Help-Button

link id:
  v: c12
text:
  v: Risks
  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: Group Table
  link id:
    v: c12.1
  text:
    v: Risk List
    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: true
  item:
    link id:
      v: c12.1.1
    text:
      v: Name of the risk
    type:
      v: string
    required:
      v: false
  item:
    link id:
      v: c12.1.2
    text:
      v: Description of Risk
    type:
      v: text
    required:
      v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c12.1.3
    text:
      v: Risk Category
    type:
      v: choice
    required:
      v: false
    answer option:
      value: Coding
    answer option:
      value: Coding
item:
  link id:
    v: c12.33
  type:
    v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: c12.9
  text:
    v: Do you want to upload the "Risk List" table instead of typing the risks directly into this questionnaire?
  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
    initial selected:
      v: true
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c12.9_help
    text:
      v: If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Risk List" table in the questionnaire.
    type:
      v: display
item:
  link id:
    v: c12.10
  text:
    v: Risk List Attachment(s)
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style
      value:
        v: color:#2a623d; font-size: 125%
  type:
    v: group
  enable when:
    question:
      v: c12.9
    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: c12.10.1
    text:
      v: Describe the file that is being attached (optional)
    type:
      v: string
    required:
      v: false
  item:
    link id:
      v: c12.10.2
    text:
      v: Upload attachment(s) here.
    type:
      v: attachment
item:
  link id:
    v: c12.37
  type:
    v: display
item:
  link id:
    v: c12.2
  text:
    v: Risk Supplemental Text
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c12.2_help
    text:
      v: Additional text for description of other risks
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: c12.3
  text:
    v: Fetal Risks
  type:
    v: choice
  required:
    v: false

v: gtable

v: Group Table

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

v: Drop down

v: PHYS

v: Physical

v: NONPHYS

v: Non-Physical

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

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: c12.3_help
text:
  v: Indicates whether risks to the fetus are possible
type:
  v: display

link id:
  v: c12.4
text:
  v: Fetal Risk Details
type:
  v: text
enable when:
  question:
    v: c12.3
  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: c12.4_help
  text:
    v: Textual description of risks to the fetus
  type:
    v: display

v: help

v: Help-Button

link id:
  v: c13
text:
  v: Alternative Procedures
  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: c13.1
  text:
    v: Alternative Procedure Text
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c13.1_help
    text:
      v: Describe any other treatment/procedure that may be used other than those described for study participation.
    type:
      v: display

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

v: Help-Button

link id:
  v: c14
text:
  v: Benefits
  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: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Group Table
  link id:
    v: c14.1
  text:
    v: Benefits List
    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: true
  item:
    link id:
      v: c14.1.1
    text:
      v: Name of Benefit
    type:
      v: string
    required:
      v: false
  item:
    link id:
      v: c14.1.2
    text:
      v: Description of Benefit
    type:
      v: text
    required:
      v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c14.1.3
    text:
      v: Benefit to you
    type:
      v: choice
    required:
      v: false
    answer option:
      value: Coding
    answer option:
      value: Coding
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c14.1.4
    text:
      v: Benefit to society
    type:
      v: choice
    required:
      v: false
    answer option:
      value: Coding
    answer option:
      value: Coding
item:
  link id:
    v: c14.31
  type:
    v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: c14.9
  text:
    v: Do you want to upload the "Benefits List" table instead of typing the benefits directly into this questionnaire?
  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
    initial selected:
      v: true
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c14.9_help
    text:
      v: If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Procedure List" table in the questionnaire.
    type:
      v: display
item:
  link id:
    v: c14.10
  text:
    v: Benefits List Attachment(s)
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style
      value:
        v: color:#2a623d; font-size: 125%
  type:
    v: group
  enable when:
    question:
      v: c14.9
    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: c14.10.1
    text:
      v: Describe the file that is being attached (optional)
    type:
      v: string
    required:
      v: false
  item:
    link id:
      v: c14.10.2
    text:
      v: Upload attachment(s) here.
    type:
      v: attachment
item:
  link id:
    v: c14.33
  type:
    v: display

v: gtable

v: Group Table

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

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

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

link id:
  v: c15
text:
  v: Compensation
  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: c15.1
  text:
    v: Will there be compensation for participation?
  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: c15.1_help
    text:
      v: Indicates whether compensation will be offered or not for the study
    type:
      v: display
item:
  link id:
    v: c15.2
  text:
    v: Compensation Supplemental Text
  type:
    v: text
  enable when:
    question:
      v: c15.1
    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: c15.2_help
    text:
      v: Additional text about compensation not captured in the compensation table
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Group Table
  link id:
    v: c15.3
  text:
    v: Compensation List
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style
      value:
        v: color:#2a623d; font-size: 125%
  type:
    v: group
  enable when:
    question:
      v: c15.1
    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: c15.3.1
    text:
      v: What types of visits or milestones will I be compensated for?
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: c15.3.2
    text:
      v: How many visits or milestones of this type will there be compensation for?
    type:
      v: integer
    required:
      v: false
  item:
    link id:
      v: c15.3.3
    text:
      v: How much will be paid per that type of visit?
    type:
      v: text
    required:
      v: false
item:
  link id:
    v: c15.33
  type:
    v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: c15.5
  text:
    v: Do you want to upload the "Compensation List" table instead of typing the risks directly into this questionnaire?
  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
    initial selected:
      v: true
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c15.5_help
    text:
      v: If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Compensation List" table in the questionnaire.
    type:
      v: display
item:
  link id:
    v: c15.7
  text:
    v: Compensation List Attachment(s)
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style
      value:
        v: color:#2a623d; font-size: 125%

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: gtable

v: Group Table

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: group

question:
  v: c15.5
operator:
  v: =
answer: Coding
  system:
    v: http://terminology.hl7.org/CodeSystem/v2-0532
  code:
    v: Y

v: false

v: true

link id:
  v: c15.7.1
text:
  v: Describe the file that is being attached (optional)
type:
  v: string
required:
  v: false

link id:
  v: c15.7.2
text:
  v: Upload attachment(s) here.
type:
  v: attachment

link id:
  v: c15.35
type:
  v: display

link id:
  v: c16
text:
  v: Costs
  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: c16.1
  text:
    v: What are the costs of participation, if any?
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c16.1_help
    text:
      v: Explanation informing participant if any additional costs will occur to the participant as a result of taking part in the study
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: c16.2
  text:
    v: Will there be reimbursement for other study visit costs incurred?
  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: c16.2_help
    text:
      v: Reimbursement to participant for other study visit costs not directly associated with a visit
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: c16.3
  text:
    v: Will costs be covered for medical treatment if research related injury occurs?
  type:
    v: choice
  required:
    v: false
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: TRTNOTCOV
      display:
        v: Treatment not covered
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: RRICOV
      display:
        v: Research Related injury covered
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: ACNOTCICOV
      display:
        v: Acute but not chronic injury covered
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c16.3_help
    text:
      v: Indicates if participant or the participant's insurance will be responsible for any injury which occurs or if the sponsor will cover any treatment costs for injury
    type:
      v: display
item:
  link id:
    v: c16.4
  text:
    v: Additional description of treatment coverage
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c16.4_help
    text:
      v: Description of other costs not directly associated with a visit
    type:
      v: display

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

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

v: Help-Button

link id:
  v: c17
text:
  v: Participant Rights and whom to contact for answers
  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: c17.1
  text:
    v: What are the rights of a participant?
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c17.1_help
    text:
      v: Statement of particpant rights
    type:
      v: display
item:
  link id:
    v: c17.2
  text:
    v: Site IRB Contact Information
    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:
    link id:
      v: c17.2.1
    text:
      v: IRB Contact Name
    type:
      v: string
    required:
      v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    link id:
      v: c17.2.8
    text:
      v: IRB Name
    type:
      v: string
    required:
      v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    link id:
      v: c17.2.9
    text:
      v: Department Name or Division
    type:
      v: string
    required:
      v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    link id:
      v: c17.2.10
    text:
      v: Street Address
    type:
      v: string
    required:
      v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    link id:
      v: c17.2.11
    text:
      v: City
    type:
      v: string
    required:
      v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    link id:
      v: c17.2.12
    text:
      v: State
    type:
      v: string
    required:
      v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    link id:
      v: c17.2.13
    text:
      v: Zip Code
    type:
      v: string
    required:
      v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    link id:
      v: c17.2.14
    text:
      v: Country
    type:
      v: string
    required:
      v: false
  item:
    link id:
      v: c17.2.20
    text:
      v: Phone
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: c17.2.20_help
      text:
        v: 10-digit phone number, including area code
      type:
        v: display
  item:
    link id:
      v: c17.2.21
    text:
      v: Email
    type:
      v: string
    required:
      v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c17.2_help
    text:
      v: Contact information for the site IRB contact.
    type:
      v: display
item:
  link id:
    v: c17.3
  text:
    v: Study Coordinator Contact Information
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style
      value:
        v: color:#2a623d; font-size: 125%
  type:
    v: group
  required:
    v: false

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

v: Help-Button

v: text/fhirpath

v: %lookupInitiateStudy.descendants().where(linkId = 'in6.1').answer.value

v: text/fhirpath

v: %lookupInitiateStudy.descendants().where(linkId = 'in6.10').answer.value

v: text/fhirpath

v: %lookupInitiateStudy.descendants().where(linkId = 'in6.3').answer.value

v: text/fhirpath

v: %lookupInitiateStudy.descendants().where(linkId = 'in6.4').answer.value

v: text/fhirpath

v: %lookupInitiateStudy.descendants().where(linkId = 'in6.5').answer.value

v: text/fhirpath

v: %lookupInitiateStudy.descendants().where(linkId = 'in6.6').answer.value

v: text/fhirpath

v: %lookupInitiateStudy.descendants().where(linkId = 'in6.7').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: help
display:
  v: Help-Button

v: Help-Button

link id:
  v: c17.3.1
text:
  v: Study Coordinator Name
type:
  v: string
required:
  v: false

link id:
  v: c17.3.8
text:
  v: Study Coordinator Institution or Organization
type:
  v: string
required:
  v: false

link id:
  v: c17.3.9
text:
  v: Department Name or Division
type:
  v: string
required:
  v: false

link id:
  v: c17.3.10
text:
  v: Street Address
type:
  v: string
required:
  v: false

link id:
  v: c17.3.11
text:
  v: City
type:
  v: string
required:
  v: false

link id:
  v: c17.3.12
text:
  v: State
type:
  v: string
required:
  v: false

link id:
  v: c17.3.13
text:
  v: Zip Code
type:
  v: string
required:
  v: false

link id:
  v: c17.3.14
text:
  v: Country
type:
  v: string
required:
  v: false

link id:
  v: c17.3.20
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: c17.3.20_help
  text:
    v: 10-digit phone number, including area code
  type:
    v: display

v: help

v: Help-Button

link id:
  v: c17.3.21
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: c17.3_help
text:
  v: Contact information for the study coordinator
type:
  v: display

link id:
  v: c17.4
text:
  v: Site Principal Investigator Contact Information
  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/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.where(linkId = 'in8.10').answer.value
  link id:
    v: c17.4.1
  text:
    v: Site Principal Investigator Name
  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: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value
  link id:
    v: c17.4.8
  text:
    v: Site Principal Investigator Institution
  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: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.10').answer.value
  link id:
    v: c17.4.9
  text:
    v: Department Name or Division
  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: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.1').answer.value
  link id:
    v: c17.4.10
  text:
    v: Street Address
  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: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.2').answer.value
  link id:
    v: c17.4.11
  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: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.3').answer.value
  link id:
    v: c17.4.12
  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: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.4').answer.value
  link id:
    v: c17.4.13
  text:
    v: Zip Code
  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: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.5').answer.value
  link id:
    v: c17.4.14
  text:
    v: Country
  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: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value
  link id:
    v: c17.4.20
  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: c17.4.20_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: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value
  link id:
    v: c17.4.21
  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

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

v: Help-Button

v: help

v: Help-Button

v: c17.4_help

v: Contact information for the PI. May be replicated from above.

v: display

link id:
  v: c18
text:
  v: Participation
  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: c18.1
  text:
    v: Voluntary Permission Statement
  type:
    v: text
  required:
    v: false
  initial:
    value:
      v: Participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c18.1_help
    text:
      v: Standard prepopulated statement, can be edited.
    type:
      v: display
item:
  link id:
    v: c18.2
  text:
    v: What are the anticipated circumstances under which participant's participation may be terminated by the investigator without regard to the participant's or the legally authorized representative's consent.
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c18.2_help
    text:
      v: Anticipated circumstances under which subject's participation may be terminated by investigator without regard to subject's or legally authorized representative's consent
    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

link id:
  v: c19
text:
  v: Early Withdrawal
  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: c19.1
  text:
    v: Are there consequences to participant for early withdrawal?
  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: Drop down
  link id:
    v: c19.2
  text:
    v: Are there Emotional Consequences of Withdrawal
  type:
    v: choice
  enable when:
    question:
      v: c19.1
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  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: Drop down
  link id:
    v: c19.3
  text:
    v: Are there Physical Consequences of Withdrawal
  type:
    v: choice
  enable when:
    question:
      v: c19.1
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  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: c19.4
  text:
    v: What are the consequences of withdrawal?
  type:
    v: text
  enable when:
    question:
      v: c19.1
    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: c19.4_help
    text:
      v: Description of the withdrawal consequences, will depend and vary based on type of study.
    type:
      v: display

v: drop-down

v: Drop down

v: drop-down

v: Drop down

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

link id:
  v: c20
text:
  v: Confidentiality of Records
  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: c20.1
  text:
    v: Will HIPAA content be included within this document?
  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:
  link id:
    v: c20.2
  text:
    v: Medical information and billing statement
  type:
    v: text
  enable when:
    question:
      v: c20.1
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  required:
    v: false
  initial:
    value:
      v: Medical information and billing records are protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA). This type of information is called protected health information (PHI). PHI about you may be obtained from any hospital, doctor, and other health care provider involved in your care.
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c20.2_help
    text:
      v: If template information required for your state differs from text provided, reword to satisfy state requirements.
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: c20.3
  text:
    v: Will confidentiality be protected?
  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: c20.3_help
    text:
      v: Indicates if records identifying a subject will be maintained.
    type:
      v: display
item:
  link id:
    v: c20.4
  text:
    v: How will confidentiality be protected?
  type:
    v: text
  enable when:
    question:
      v: c20.3
    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: c20.4_help
    text:
      v: Explanation about processes and procedures to support maintaining privacy and confidentiality
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: c20.5
  text:
    v: Are there data security or policies that need to be included in the consent, particularly around device use (optional)
  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: c20.5_help
    text:
      v: Indicates if any data security policy applies to this consent, including device use.
    type:
      v: display
item:
  link id:
    v: c20.6
  text:
    v: Describe any data security policies and processes protecting the data
  type:
    v: text
  enable when:
    question:
      v: c20.5
    operator:
      v: =
    answer: Coding

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

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

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: c20.6_help
text:
  v: Optional field for capturing information on IT related data security policies. Example, use of encryption when utilizing mobile data collection
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: c20.7
text:
  v: Who can use or see participant information?
  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: true
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: c20.7.1
  text:
    v: Role or group who will have access to data
  type:
    v: open-choice
  required:
    v: false
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: OTHINSTRES
      display:
        v: Researchers at other institutions
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: THISINSTRES
      display:
        v: Researchers outside the study team at this institution
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: EXTREGAUTH
      display:
        v: External Regulatory Authorities
item:
  link id:
    v: c20.7.2
  text:
    v: Description of Information Disclosed
  type:
    v: text
  required:
    v: false

v: drop-down

v: Drop down

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: c20.8
text:
  v: Will the data be released for future use?
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: c20.8_help
  text:
    v: Indicates whether these data will be used beyond the study window
  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: c20.9
text:
  v: Will the future use data be deidentified?
type:
  v: choice
enable when:
  question:
    v: c20.8
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
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: c20.9_help
  text:
    v: Indicates if shared data will retain any identifiers.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: c20.10
text:
  v: Deidentification detail
type:
  v: text
enable when:
  question:
    v: c20.9
  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: c20.10_help
  text:
    v: Description of deidentification details for future use datasets.
  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: c20.11
text:
  v: Required text disclosure surrounding future use.
type:
  v: choice
enable when:
  question:
    v: c20.8
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
required:
  v: false
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: DEIDUSED
    display:
      v: Identifiers might be removed from private information or biospecimens, and this information could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent.
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: DEIDNOTUSED
    display:
      v: Information or biospecimens collected will not be used or distributed for future research studies, even if deidentified.
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: c20.11_help
  text:
    v: Select the appropriate required text statement about disclosure surrounding future use of participant's data from the two standardized statements.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: c21
text:
  v: Specimen Management
  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: c21.1
  text:
    v: Were specimens collected as part of this study?
  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: Drop down
  link id:
    v: c21.2
  text:
    v: Is whole genome sequencing being conducted?
  type:
    v: choice
  enable when:
    question:
      v: c21.1
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  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: c21.2_help
    text:
      v: Indicator of if genome sequencing is being conducted in conjunction with study
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: c21.3
  text:
    v: Sharing or no Sharing of samples.
  type:
    v: choice
  enable when:
    question:
      v: c21.1
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  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: c21.3_help
    text:
      v: Indicator of whether biospecimens will be shared outside of the immediate study team or institution.
    type:
      v: display
item:
  link id:
    v: c21.4
  text:
    v: Conditions of sharing
  type:
    v: text
  enable when:
    question:
      v: c21.3
    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: c21.4_help
    text:
      v: Textual description of sharing conditions including, type, when, etc.
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: c21.5
  text:
    v: Will participant share in profit with commerical use?
  type:
    v: choice
  enable when:
    question:
      v: c21.1
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y

v: drop-down

v: Drop down

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

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: 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: c21.5_help
text:
  v: Indicator of any plans to profit share any funds received as a result of commercial use of those samples.
type:
  v: display

link id:
  v: c21.6
text:
  v: Description of Collection and Storage
type:
  v: text
enable when:
  question:
    v: c21.1
  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: c21.6_help
  text:
    v: Textual description of collection and storage procedures and policies for the 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: c21.7
text:
  v: Can consent for sample use be revoked?
type:
  v: choice
enable when:
  question:
    v: c21.1
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
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: c21.7_help
  text:
    v: Indicator of revocation of sample consent is an option
  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: c22
text:
  v: Will there be Broad Consent for Storage, maintenance and secondary research use?
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:
  link id:
    v: c22.1
  text:
    v: Statement of Broad Consent for Storage, maintenance and secondary research use
  type:
    v: text
  enable when:
    question:
      v: c22
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  initial:
    value:
      v: Participant identifiable information and identifiable biospecimens will be stored, used and shared for the kinds of future research described in this broad consent form, without anyone asking your permission for each new study. Identifying information may also be removed from your information and biospecimens, allowing them to be used for any future research or other purpose.

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: c23
text:
  v: Can the study team contact you for future 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:
  link id:
    v: c23.1
  text:
    v: Conditions about contact for additional sample use, information not currently described or future research
  type:
    v: text
  enable when:
    question:
      v: c23
    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: c23.1_help
    text:
      v: Description of the details for which the participant could be contacted
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: c23_help
  text:
    v: Indicator if the participant contact information can be used for future questions or recuitment for this or other studies
  type:
    v: display

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: c24
text:
  v: Will participants share in commercial profit?
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:
  link id:
    v: c24.1
  text:
    v: Details about any profit sharing agreements or why profits will not be shared.
  type:
    v: text
  enable when:
    question:
      v: c24
    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: c24_help
  text:
    v: Indicator of participants will receive any commercial profits resulting from their participation in 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: c25
text:
  v: Will the study team contact you with new information that may affect your willingness to remain in the study
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: c25_help
  text:
    v: Indicator if study team will provide updates that may affect willingness to remain in 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: c26
text:
  v: Will the study team disclose clinically relevant study results to you?
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:
  link id:
    v: c26.1
  text:
    v: Condtions under which the study results will be disclosed to you
  type:
    v: text
  enable when:
    question:
      v: c26
    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: c26.1_help
    text:
      v: Textual description of which results and when will be disclosed to you.
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: c26_help
  text:
    v: Indicator of study team will provide results of lab tests or other feedback of results to you at any time.
  type:
    v: display

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: c27
text:
  v: Clinical Trials.gov statement
type:
  v: text
required:
  v: false
read only:
  v: true
initial:
  value:
    v: A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

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: c28
text:
  v: Is this study covered under a Certificate of Confidentiality? (default Y in NIH)
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:
  link id:
    v: c28.1
  text:
    v: Certificate of Confidentiality Statement
  type:
    v: text
  enable when:
    question:
      v: c28
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  required:
    v: false
  read only:
    v: true
  initial:
    value:
      v: The Department of Health and Human Services (HHS) has issued a Certificate of Confidentiality to further protect your privacy. With this Certificate, the investigators may not disclose research information that may identify you in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings, unless you have consented for this use.[trunc]
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c28.1_help
    text:
      v: Indicator if study is covered under a certificate of confidentiality (automatially issued for NIH studies)
    type:
      v: display
item:
  link id:
    v: c28.2
  text:
    v: Required Disclosures based on state law
  type:
    v: text
  enable when:
    question:
      v: c28
    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: c28.2_help
    text:
      v: Add any required text per your state laws.
    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

link id:
  v: c29
text:
  v: When will the PHI Authorization Expire based on date or time past an event
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: c29_help
  text:
    v: PHI authorization expiration. Might be never, a certain date, or a period after a study milestone, such as 6 months after study closure.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: c30
text:
  v: Statement of PHI Authorization Revocation
type:
  v: text
required:
  v: false
initial:
  value:
    v: Participants have the ability to revoke their consent to share PHI at any time but that there are limitations on what restrictions can apply to data that has already been shared.

link id:
  v: c31
text:
  v: Signature
  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: c31.1
  text:
    v: Indicator to include Participant Signature and Date/Time
  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: Drop down
  link id:
    v: c31.2
  text:
    v: Indicator to include Assent Signature and Date/Time
  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: Drop down
  link id:
    v: c31.3
  text:
    v: Indicator to include Legally Authorized Representative Signature and Date/Time
  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: Drop down
  link id:
    v: c31.4
  text:
    v: Relationship of Legally Authorized Representative
  type:
    v: choice
  required:
    v: false
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0063
      code:
        v: PAR
      display:
        v: Parent
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0063
      code:
        v: SPO
      display:
        v: Spouse
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0063
      code:
        v: CHD
      display:
        v: Child
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0063
      code:
        v: SIB
      display:
        v: Sibling
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0063
      code:
        v: GRD
      display:
        v: Guardian
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0063
      code:
        v: OTH
      display:
        v: Other
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: c31.5
  text:
    v: Indicator to include a Witness Signature and Date/Time
  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

v: drop-down

v: Drop down

v: drop-down

v: Drop down

v: drop-down

v: Drop down

v: drop-down

v: Drop down

v: drop-down

v: Drop down

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: c31.6
text:
  v: Indicator to include Parent 1 Signature and Date/Time
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

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: c31.7
text:
  v: Indicator to include Parent 2 Signature and Date/Time
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

link id:
  v: c32
text:
  v: Consent Version
  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: c32.1
  text:
    v: Consent Version Number
  type:
    v: string
  required:
    v: false
item:
  link id:
    v: c32.2
  text:
    v: sIRB Version Date of Consent
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c32.2_help
    text:
      v: Date that changes whenever a change is made to the consent. It is the versioning system of the sIRB institution, and is updated in accordance with the institution's policy.
    type:
      v: display
item:
  link id:
    v: c32.3
  text:
    v: Relying Site Version Date of Consent
  type:
    v: date
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: c32.3_help
    text:
      v: A number that changes whenever a change is made to the consent. It is the versioning system of the relying institution, and is updated in accordance with the institution's policy.
    type:
      v: display
item:
  link id:
    v: c32.6
  text:
    v: Expiration Date of Consent
  type:
    v: dateTime
  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

link id:
  v: c80
text:
  v: Other 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: c80.1
  text:
    v: Describe the file that is being attached (optional)
  type:
    v: string
item:
  link id:
    v: c80.2
  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: c80_help
  text:
    v: Other attachments that will be included in the Consent Form that will be provided to the participants should 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: c
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, 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
  link id:
    v: ADMIN04
  text:
    v: Questionnaire Response ID of the local considerations Questionnaire Response, if any
  type:
    v: string
  required:
    v: false