sirb-continuing-review-questionnaire-populate
type: Questionnaire
node role: treeRoot
id:
  v: sirb-continuing-review-questionnaire-populate
text:
  status:
    v: generated
  div: Structure LinkId Text Cardinality Type Flags Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> Continuing_review Questionnaire http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire-populate#1.0.0 cr1 Research Study 0..1 group cr1.1 Study Title 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value cr1.1_help Study Title from the Informed Consent 0..1 display cr1.2 IRB Protocol Number 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value cr1.2_help Number assigned to the protocol by IRB 0..1 display cr1.3 Enrollment Status 0..1 choice Options: 4 options cr1.4 Intervention Status 0..1 choice Options: 3 options cr1.4_help Current intervention status. This can be used by the IRB to determine that continuing review is no longer required. 0..1 display cr1.5 Study Status 0..1 choice Options: 9 options cr1.5_help Status of the study overall. Study Status can also be used by the IRB to determine that continuing review is no longer required. 0..1 display cr1.6 Funding Source(check all that are applicable) 0..* choice Options: 7 options cr1.6_help The funding source for the study. Note that a single study can have multiple funding sources and that the funding sources can change over time. 0..1 display cr1.7 Other Funding Source-Please specify: 0..1 string Enable When: cr1.6 = Other Funding Source (Temporary Codes#otherfund) cr12 sIRB (Reviewing Institution) 0..1 group cr12.1 sIRB (Reviewing Institution) Name 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.1').answer.value cr9 Submission Type 0..1 group cr9.1 Is this Continuing Review Form being submitted by the lead PI site on behalf of all of the relying sites? 1..1 choice Options: 2 options cr9.1_help Select "Yes" if this Continuing Review Form is being completed by the lead principal investigator si…
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: submission type (overall study or site-specific)
    name:
      v: overallCRForm
    language:
      v: text/fhirpath
    expression:
      v: %resource.descendants().where(linkId = 'cr9.1').answer.valueCoding.code
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: site that this Continuing Review form pertains to
    name:
      v: siteForForm
    language:
      v: text/fhirpath
    expression:
      v: %resource.descendants().where(linkId = 'cr9.2').answer.valueCoding.display
url:
  v: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire-populate
version:
  v: 1.0.0
name:
  v: Continuing_review
title:
  v: Continuing Review
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: cr1
  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
  repeats:
    v: false
  read only:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    link id:
      v: cr1.1
    text:
      v: Study Title
    type:
      v: string
    required:
      v: false
    read only:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: cr1.1_help
      text:
        v: Study Title from the Informed Consent
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    link id:
      v: cr1.2
    text:
      v: IRB Protocol Number
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: cr1.2_help
      text:
        v: Number assigned to the protocol by IRB
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: cr1.3
    text:
      v: Enrollment Status
    type:
      v: choice
    required:
      v: false
    answer option:
      value: Coding
    answer option:
      value: Coding
    answer option:
      value: Coding
    answer option:
      value: Coding
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: cr1.4
    text:
      v: Intervention Status
    type:
      v: choice
    required:
      v: false
    answer option:
      value: Coding
    answer option:
      value: Coding

v: text/fhirpath

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

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

v: text/fhirpath

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

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

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

v: Drop down

v: not-open

v: Not yet open

v: open-no-participants

v: Open with no participants

v: open

v: Open for enrollment

v: closed

v: Closed to enrollment

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

v: Drop down

v: complete

v: All interventions complete

v: continue-meds

v: Continuing interventions

value: Coding
  system:
    v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
  code:
    v: continue-min-risk
  display:
    v: Continuing interventions - minimal risk

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: cr1.4_help
text:
  v: Current intervention status. This can be used by the IRB to determine that continuing review is no longer required.
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: cr1.5
text:
  v: Study Status
type:
  v: choice
required:
  v: false
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/research-study-status
    code:
      v: active
    display:
      v: Active
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/research-study-status
    code:
      v: disapproved
    display:
      v: Disapproved
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/research-study-status
    code:
      v: closed-to-accrual
    display:
      v: Closed to Accrual
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/research-study-status
    code:
      v: closed-to-accrual-and-intervention
    display:
      v: Closed to Accrual and Intervention
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/research-study-status
    code:
      v: completed
    display:
      v: Completed
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/research-study-status
    code:
      v: administratively-completed
    display:
      v: Administratively Completed
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/research-study-status
    code:
      v: temporarily-closed-to-accrual
    display:
      v: Temporarily Closed to Accrual
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/research-study-status
    code:
      v: temporarily-closed-to-accrual-and-intervention
    display:
      v: Temporarily Closed to Accrual and Intervention
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/research-study-status
    code:
      v: withdrawn
    display:
      v: Withdrawn
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: cr1.5_help
  text:
    v: Status of the study overall. Study Status can also be used by the IRB to determine that continuing review is no longer required.
  type:
    v: display

v: help

v: Help-Button

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: check-box
      display:
        v: Check-box
    text:
      v: Check-box
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation
  value:
    v: vertical
link id:
  v: cr1.6
text:
  v: Funding Source(check all that are applicable)
type:
  v: choice
required:
  v: false
repeats:
  v: true
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: federal
    display:
      v: Federal
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: state
    display:
      v: State
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: industry
    display:
      v: Industry
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: foundation
    display:
      v: Foundation
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: institutional
    display:
      v: Institutional
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: departmental
    display:
      v: Departmental
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: otherfund
    display:
      v: Other Funding Source
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: cr1.6_help
  text:
    v: The funding source for the study. Note that a single study can have multiple funding sources and that the funding sources can change over time.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: cr1.7
text:
  v: Other Funding Source-Please specify:
type:
  v: string
enable when:
  question:
    v: cr1.6
  operator:
    v: =
  answer: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: otherfund
required:
  v: false

link id:
  v: cr12
text:
  v: sIRB (Reviewing Institution)
  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
      language:
        v: text/fhirpath
      expression:
        v: %lookupInitiateStudy.descendants().where(linkId = 'in6.1').answer.value
  link id:
    v: cr12.1
  text:
    v: sIRB (Reviewing Institution) Name
  type:
    v: string
  required:
    v: false

link id:
  v: cr9
text:
  v: Submission Type
  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: cr9.1
  text:
    v: Is this Continuing Review Form being submitted by the lead PI site on behalf of all of the relying sites?
  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
    link id:
      v: cr9.1_help
    text:
      v: Select "Yes" if this Continuing Review Form is being completed by the lead principal investigator site, the study coordinating center or other administrative unit on behalf of all the relying sites in the overall study.
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: %lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').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_cr9.2
  text:
    v: External Data For linkId cr9.2
  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_cr9.2').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: cr9.2
  text:
    v: If this Continuing Review Form is specific to a relying site, select the relying site in order to pre-populate the relying institution and relying site principal investigator details below.
  type:
    v: choice
  enable when:
    question:
      v: cr9.1
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: cr9.2_help
    text:
      v: This question and its answer will not print on the Continuing Review Form but are necessary for the form logic. If you do not want pre-population to occur, leave this question blank and manually fill in the relying institution and relying site principal investigator details.
    type:
      v: display

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

link id:
  v: cr11
text:
  v: Site Principal Investigator Institution
  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
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value)
  link id:
    v: cr11.1
  text:
    v: Site Principal Investigator Institution Name
  type:
    v: string
  required:
    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-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.10').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.1.10').answer.value)
  link id:
    v: cr11.2
  text:
    v: Institution Department Name or Division
  type:
    v: string
  required:
    v: false

v: drop-down

v: Drop down

v: drop-down

v: Drop down

link id:
  v: cr2
text:
  v: Site Principal Investigator
  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-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.1').answer.value)
  link id:
    v: cr2.1
  text:
    v: First Name
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: cr2.1_help
    text:
      v: First or given name of the site principal investigator
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.2').answer.value)
  link id:
    v: cr2.4
  text:
    v: Last Name
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: cr2.4_help
    text:
      v: Surname or family name
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.3').answer.value)
  link id:
    v: cr2.5
  text:
    v: Suffix
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: cr2.5_help
    text:
      v: Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.4').answer.value)
  link id:
    v: cr2.6
  text:
    v: Degree(s)
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: cr2.6_help
    text:
      v: Professional and Academic degrees of the site principal investigator
    type:
      v: display
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-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.10').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.10').answer.value)
  link id:
    v: cr2.10
  text:
    v: Site Principal Investigator 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: iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value)
  link id:
    v: cr2.2
  text:
    v: Phone
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: cr2.2_help
    text:
      v: 10-digit phone number, including area code
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value)
  link id:
    v: cr2.3
  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: cr2.3_help
    text:
      v: Email address for site PI

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

v: Help-Button

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

v: Help-Button

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

v: Help-Button

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

v: Help-Button

v: drop-down

v: Drop down

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

v: Help-Button

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

v: Help-Button

v: display

link id:
  v: cr7
text:
  v: Report Type
  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: Drop down
  link id:
    v: cr7.1
  text:
    v: Is this an initial report?
  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: cr7.1_help
    text:
      v: An initial report is the first time that the study is reviewed.
    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: cr3
text:
  v: Accrual of Participants
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#274e90; font-size: 150%
type:
  v: group
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: cr3_help
  text:
    v: The number of participants who are enrolled, approved to enroll, consented, withdrawn, lost to contact, screen failures, active or in follow-up, or completed study.
  type:
    v: display
item:
  link id:
    v: cr3.1
  text:
    v: Provide counts for the following
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style
      value:
        v: color:#2a623d; font-size: 125%
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: cr3.1.15
    text:
      v: If this is an initial review, provide counts since study inception. The count for the Previous Accrual should be entered as 0 when completing the questionnaire for the initial report.
    type:
      v: display
    enable when:
      question:
        v: cr7.1
      operator:
        v: =
      answer: Coding
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: cr3.1.1
    text:
      v: Participants enrolled since activation
    type:
      v: group
    required:
      v: false
    item:
      link id:
        v: cr3.1.1.1
      text:
        v: Previous Accrual
      type:
        v: integer
    item:
      link id:
        v: cr3.1.1.2
      text:
        v: Additional enrollees this approval period
      type:
        v: integer
    item:
      extension:
        value: Expression
      link id:
        v: cr3.1.1.3
      text:
        v: Total
      type:
        v: integer
  item:
    link id:
      v: cr3.1.31
    type:
      v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: cr3.1.2
    text:
      v: Participants enrolled since last approval
    type:
      v: group
    required:
      v: false
    item:
      link id:
        v: cr3.1.2.1
      text:
        v: Previous Accrual
      type:
        v: integer
    item:
      link id:
        v: cr3.1.2.2
      text:
        v: Additional enrollees this approval period
      type:
        v: integer
    item:
      extension:
        value: Expression
      link id:
        v: cr3.1.2.3
      text:
        v: Total
      type:
        v: integer
  item:
    link id:
      v: cr3.1.32
    type:
      v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: cr3.1.3
    text:
      v: Participants approved to enroll
    type:
      v: group
    required:
      v: false
    item:
      link id:
        v: cr3.1.3.1
      text:
        v: Previous Accrual
      type:
        v: integer
    item:
      link id:
        v: cr3.1.3.2
      text:
        v: Additional enrollees this approval period
      type:
        v: integer
    item:
      extension:
        value: Expression
      link id:
        v: cr3.1.3.3
      text:
        v: Total
      type:
        v: integer
  item:
    link id:
      v: cr3.1.33
    type:
      v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: cr3.1.4
    text:
      v: Participants consented
    type:
      v: group
    required:
      v: false
    item:
      link id:
        v: cr3.1.4.1
      text:
        v: Previous Accrual
      type:
        v: integer
    item:
      link id:
        v: cr3.1.4.2
      text:
        v: Additional enrollees this approval period
      type:
        v: integer

v: help

v: Help-Button

v: color:#5caf42; font-size: 115%; font-weight:bold

v: Y

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

v: gtable

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

Expression
language:
  v: text/fhirpath
expression:
  v: %resource.descendants().where(linkId = 'cr3.1.1.1').answer.value + %resource.descendants().where(linkId = 'cr3.1.1.2').answer.value

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

v: gtable

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

Expression
language:
  v: text/fhirpath
expression:
  v: %resource.descendants().where(linkId = 'cr3.1.2.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.2.2').answer.value.toInteger()

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

v: gtable

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

Expression
language:
  v: text/fhirpath
expression:
  v: %resource.descendants().where(linkId = 'cr3.1.3.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.3.2').answer.value.toInteger()

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

v: gtable

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

extension:
  url:
    v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: %resource.descendants().where(linkId = 'cr3.1.4.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.4.2').answer.value.toInteger()
link id:
  v: cr3.1.4.3
text:
  v: Total
type:
  v: integer

link id:
  v: cr3.1.34
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: gtable
      display:
        v: Group Table
    text:
      v: gtable
link id:
  v: cr3.1.5
text:
  v: Participants withdrawn
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#425caf; font-size: 115%; font-weight:bold
type:
  v: group
required:
  v: false
item:
  link id:
    v: cr3.1.5.1
  text:
    v: Previous Accrual
  type:
    v: integer
item:
  link id:
    v: cr3.1.5.2
  text:
    v: Additional enrollees this approval period
  type:
    v: integer
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: %resource.descendants().where(linkId = 'cr3.1.5.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.5.2').answer.value.toInteger()
  link id:
    v: cr3.1.5.3
  text:
    v: Total
  type:
    v: integer

link id:
  v: cr3.1.35
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: gtable
link id:
  v: cr3.1.6
text:
  v: Participants lost to contact
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#425caf; font-size: 115%; font-weight:bold
type:
  v: group
required:
  v: false
item:
  link id:
    v: cr3.1.6.1
  text:
    v: Previous Accrual
  type:
    v: integer
item:
  link id:
    v: cr3.1.6.2
  text:
    v: Additional enrollees this approval period
  type:
    v: integer
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: %resource.descendants().where(linkId = 'cr3.1.6.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.6.2').answer.value.toInteger()
  link id:
    v: cr3.1.6.3
  text:
    v: Total
  type:
    v: integer

link id:
  v: cr3.1.36
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: gtable
link id:
  v: cr3.1.7
text:
  v: Participants with screen failures
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#425caf; font-size: 115%; font-weight:bold
type:
  v: group
required:
  v: false
item:
  link id:
    v: cr3.1.7.1
  text:
    v: Previous Accrual
  type:
    v: integer
item:
  link id:
    v: cr3.1.7.2
  text:
    v: Additional enrollees this approval period
  type:
    v: integer
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: %resource.descendants().where(linkId = 'cr3.1.7.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.7.2').answer.value.toInteger()
  link id:
    v: cr3.1.7.3
  text:
    v: Total
  type:
    v: integer

link id:
  v: cr3.1.37
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: gtable
link id:
  v: cr3.1.8
text:
  v: Participants still active or follow-up
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#425caf; font-size: 115%; font-weight:bold
type:
  v: group
required:
  v: false
item:
  link id:
    v: cr3.1.8.1
  text:
    v: Previous Accrual
  type:
    v: integer
item:
  link id:
    v: cr3.1.8.2
  text:
    v: Additional enrollees this approval period
  type:
    v: integer
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: %resource.descendants().where(linkId = 'cr3.1.8.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.8.2').answer.value.toInteger()
  link id:
    v: cr3.1.8.3
  text:
    v: Total
  type:
    v: integer

link id:
  v: cr3.1.38
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: gtable
link id:
  v: cr3.1.9
text:
  v: Participants completed study
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#425caf; font-size: 115%; font-weight:bold
type:
  v: group
required:
  v: false
item:
  link id:
    v: cr3.1.9.1
  text:
    v: Previous Accrual
  type:
    v: integer
item:
  link id:
    v: cr3.1.9.2
  text:
    v: Additional enrollees this approval period
  type:
    v: integer
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: %resource.descendants().where(linkId = 'cr3.1.9.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.9.2').answer.value.toInteger()
  link id:
    v: cr3.1.9.3
  text:
    v: Total
  type:
    v: integer

link id:
  v: cr3.1.39
type:
  v: display

link id:
  v: cr3.1.10
text:
  v: By Sex
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#425caf; font-size: 115%; font-weight:bold
type:
  v: group
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: gtable
  link id:
    v: cr3.1.10.1
  text:
    v: Men
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: cr3.1.10.1.1
    text:
      v: Previous Accrual
    type:
      v: integer
  item:
    link id:
      v: cr3.1.10.1.2
    text:
      v: Additional enrollees this approval period
    type:
      v: integer
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: cr3.1.10.1.3
    text:
      v: Total
    type:
      v: integer
item:
  link id:
    v: cr3.1.10.31
  type:
    v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: gtable
  link id:
    v: cr3.1.10.2
  text:
    v: Women
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: cr3.1.10.2.1
    text:
      v: Previous Accrual
    type:
      v: integer
  item:
    link id:
      v: cr3.1.10.2.2
    text:
      v: Additional enrollees this approval period
    type:
      v: integer
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: cr3.1.10.2.3
    text:
      v: Total
    type:
      v: integer

v: gtable

v: Group Table

v: text/fhirpath

v: %resource.descendants().where(linkId = 'cr3.1.10.1.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.10.1.2').answer.value.toInteger()

v: gtable

v: Group Table

v: text/fhirpath

v: %resource.descendants().where(linkId = 'cr3.1.10.2.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.10.2.2').answer.value.toInteger()

link id:
  v: cr3.1.40
type:
  v: display

link id:
  v: cr3.1.11
text:
  v: By Race
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#425caf; font-size: 115%; font-weight:bold
type:
  v: group
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: gtable
  link id:
    v: cr3.1.11.1
  text:
    v: White
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: cr3.1.11.1.1
    text:
      v: Previous Accrual
    type:
      v: integer
  item:
    link id:
      v: cr3.1.11.1.2
    text:
      v: Additional enrollees this approval period
    type:
      v: integer
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: cr3.1.11.1.3
    text:
      v: Total
    type:
      v: integer
item:
  link id:
    v: cr3.1.11.31
  type:
    v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: gtable
  link id:
    v: cr3.1.11.2
  text:
    v: Black or African American
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: cr3.1.11.2.1
    text:
      v: Previous Accrual
    type:
      v: integer
  item:
    link id:
      v: cr3.1.11.2.2
    text:
      v: Additional enrollees this approval period
    type:
      v: integer
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: cr3.1.11.2.3
    text:
      v: Total
    type:
      v: integer
item:
  link id:
    v: cr3.1.11.32
  type:
    v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: gtable
  link id:
    v: cr3.1.11.3
  text:
    v: Asian
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: cr3.1.11.3.1
    text:
      v: Previous Accrual
    type:
      v: integer
  item:
    link id:
      v: cr3.1.11.3.2
    text:
      v: Additional enrollees this approval period
    type:
      v: integer
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: cr3.1.11.3.3
    text:
      v: Total
    type:
      v: integer
item:
  link id:
    v: cr3.1.11.33
  type:
    v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: gtable
  link id:
    v: cr3.1.11.4
  text:
    v: American Indian or Alaska Native
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: cr3.1.11.4.1
    text:
      v: Previous Accrual
    type:
      v: integer
  item:
    link id:
      v: cr3.1.11.4.2
    text:
      v: Additional enrollees this approval period
    type:
      v: integer
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: cr3.1.11.4.3
    text:
      v: Total
    type:
      v: integer
item:
  link id:
    v: cr3.1.11.34
  type:
    v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: gtable
  link id:
    v: cr3.1.11.5

v: gtable

v: Group Table

v: text/fhirpath

v: %resource.descendants().where(linkId = 'cr3.1.11.1.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.1.2').answer.value.toInteger()

v: gtable

v: Group Table

v: text/fhirpath

v: %resource.descendants().where(linkId = 'cr3.1.11.2.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.2.2').answer.value.toInteger()

v: gtable

v: Group Table

v: text/fhirpath

v: %resource.descendants().where(linkId = 'cr3.1.11.3.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.3.2').answer.value.toInteger()

v: gtable

v: Group Table

v: text/fhirpath

v: %resource.descendants().where(linkId = 'cr3.1.11.4.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.4.2').answer.value.toInteger()

v: gtable

v: Group Table

v: Native Hawaiian or other Pacific Islander

v: group

v: false

link id:
  v: cr3.1.11.5.1
text:
  v: Previous Accrual
type:
  v: integer

link id:
  v: cr3.1.11.5.2
text:
  v: Additional enrollees this approval period
type:
  v: integer

extension:
  url:
    v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: %resource.descendants().where(linkId = 'cr3.1.11.5.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.5.2').answer.value.toInteger()
link id:
  v: cr3.1.11.5.3
text:
  v: Total
type:
  v: integer

link id:
  v: cr3.1.11.35
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: gtable
link id:
  v: cr3.1.11.6
text:
  v: More than One Race
type:
  v: group
required:
  v: false
item:
  link id:
    v: cr3.1.11.6.1
  text:
    v: Previous Accrual
  type:
    v: integer
item:
  link id:
    v: cr3.1.11.6.2
  text:
    v: Additional enrollees this approval period
  type:
    v: integer
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: %resource.descendants().where(linkId = 'cr3.1.11.6.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.6.2').answer.value.toInteger()
  link id:
    v: cr3.1.11.6.3
  text:
    v: Total
  type:
    v: integer

link id:
  v: cr3.1.11.36
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: gtable
link id:
  v: cr3.1.11.7
text:
  v: Unknown/Not Reported
type:
  v: group
required:
  v: false
item:
  link id:
    v: cr3.1.11.7.1
  text:
    v: Previous Accrual
  type:
    v: integer
item:
  link id:
    v: cr3.1.11.7.2
  text:
    v: Additional enrollees this approval period
  type:
    v: integer
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: %resource.descendants().where(linkId = 'cr3.1.11.7.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.7.2').answer.value.toInteger()
  link id:
    v: cr3.1.11.7.3
  text:
    v: Total
  type:
    v: integer

link id:
  v: cr3.1.41
type:
  v: display

link id:
  v: cr3.1.12
text:
  v: By Ethnicity
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#425caf; font-size: 115%; font-weight:bold
type:
  v: group
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: gtable
  link id:
    v: cr3.1.12.1
  text:
    v: Hispanic or Latino
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: cr3.1.12.1.1
    text:
      v: Previous Accrual
    type:
      v: integer
  item:
    link id:
      v: cr3.1.12.1.2
    text:
      v: Additional enrollees this approval period
    type:
      v: integer
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: cr3.1.12.1.3
    text:
      v: Total
    type:
      v: integer
item:
  link id:
    v: cr3.1.12.31
  type:
    v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: gtable
  link id:
    v: cr3.1.12.2
  text:
    v: Not Hispanic or Latino
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: cr3.1.12.2.1
    text:
      v: Previous Accrual
    type:
      v: integer
  item:
    link id:
      v: cr3.1.12.2.2
    text:
      v: Additional enrollees this approval period
    type:
      v: integer
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: cr3.1.12.2.3
    text:
      v: Total
    type:
      v: integer
item:
  link id:
    v: cr3.1.12.32
  type:
    v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: gtable
  link id:
    v: cr3.1.12.3
  text:
    v: Unknown/Not Reported
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: cr3.1.12.3.1
    text:
      v: Previous Accrual
    type:
      v: integer
  item:
    link id:
      v: cr3.1.12.3.2
    text:
      v: Additional enrollees this approval period
    type:
      v: integer
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: cr3.1.12.3.3
    text:
      v: Total
    type:
      v: integer

v: gtable

v: Group Table

v: text/fhirpath

v: %resource.descendants().where(linkId = 'cr3.1.12.1.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.12.1.2').answer.value.toInteger()

v: gtable

v: Group Table

v: text/fhirpath

v: %resource.descendants().where(linkId = 'cr3.1.12.2.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.12.2.2').answer.value.toInteger()

v: gtable

v: Group Table

v: text/fhirpath

v: %resource.descendants().where(linkId = 'cr3.1.12.3.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.12.3.2').answer.value.toInteger()

link id:
  v: cr3.1.42
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: cr3.1_help
text:
  v: Number of participants by category
type:
  v: display

link id:
  v: cr3.2
text:
  v: Vulnerable Populations
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#2a623d; font-size: 125%
type:
  v: group
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: gtable
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#2a623d; font-size: 115%
  link id:
    v: cr3.2.1
  text:
    v: Number of potentially vulnerable participants enrolled
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style
      value:
        v: color:#425caf; font-size: 115%; font-weight:bold
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: cr3.2.1.1
    text:
      v: Previous Accrual
    type:
      v: integer
  item:
    link id:
      v: cr3.2.1.2
    text:
      v: Additional enrollees this approval period
    type:
      v: integer
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: cr3.2.1.3
    text:
      v: Total
    type:
      v: integer
item:
  link id:
    v: cr3.2.30
  type:
    v: display
item:
  link id:
    v: cr3.2.2
  text:
    v: Check the applicable checkboxes if these groups are represented in the columns above
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style
      value:
        v: color:#425caf; font-size: 115%; font-weight:bold
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: cr3.2.2.15
    text:
      v: For an initial report, skip the checkboxes for Previous Accrual
    type:
      v: display
    enable when:
      question:
        v: cr7.1
      operator:
        v: =
      answer: Coding
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation
      value:
        v: vertical
    link id:
      v: cr3.2.2.1
    text:
      v: Children
    type:
      v: choice
    required:
      v: false
    repeats:
      v: true
    answer option:
      value: Coding
    answer option:
      value: Coding
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation
      value:
        v: vertical
    link id:
      v: cr3.2.2.2
    text:
      v: Cognitively Impaired
    type:
      v: choice
    required:
      v: false
    repeats:
      v: true
    answer option:
      value: Coding
    answer option:
      value: Coding
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation
      value:
        v: vertical
    link id:
      v: cr3.2.2.3
    text:
      v: Employees
    type:
      v: choice
    required:
      v: false
    repeats:
      v: true
    answer option:
      value: Coding
    answer option:
      value: Coding
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation
      value:
        v: vertical
    link id:
      v: cr3.2.2.4
    text:
      v: Fetuses
    type:
      v: choice
    required:
      v: false
    repeats:
      v: true
    answer option:
      value: Coding
    answer option:
      value: Coding
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation
      value:
        v: vertical
    link id:
      v: cr3.2.2.5

v: gtable

v: Group Table

v: text/fhirpath

v: %resource.descendants().where(linkId = 'cr3.2.1.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.2.1.2').answer.value.toInteger()

v: color:#5caf42; font-size: 115%; font-weight:bold

v: Y

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

v: Check-box

v: PreviousAccrual

v: Previous Accrual

v: AdditionalEnrollees

v: Additional enrollees this approval period

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

v: Check-box

v: PreviousAccrual

v: Previous Accrual

v: AdditionalEnrollees

v: Additional enrollees this approval period

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

v: Check-box

v: PreviousAccrual

v: Previous Accrual

v: AdditionalEnrollees

v: Additional enrollees this approval period

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

v: Check-box

v: PreviousAccrual

v: Previous Accrual

v: AdditionalEnrollees

v: Additional enrollees this approval period

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

v: Check-box

v: Neonates (non-viable / uncertain viability)

v: choice

v: false

v: true

value: Coding
  system:
    v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
  code:
    v: PreviousAccrual
  display:
    v: Previous Accrual

value: Coding
  system:
    v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
  code:
    v: AdditionalEnrollees
  display:
    v: Additional enrollees this approval period

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: check-box
      display:
        v: Check-box
    text:
      v: Check-box
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation
  value:
    v: vertical
link id:
  v: cr3.2.2.6
text:
  v: Pregnant Women
type:
  v: choice
required:
  v: false
repeats:
  v: true
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: PreviousAccrual
    display:
      v: Previous Accrual
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: AdditionalEnrollees
    display:
      v: Additional enrollees this approval period

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: check-box
      display:
        v: Check-box
    text:
      v: Check-box
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation
  value:
    v: vertical
link id:
  v: cr3.2.2.7
text:
  v: Prisoners
type:
  v: choice
required:
  v: false
repeats:
  v: true
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: PreviousAccrual
    display:
      v: Previous Accrual
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: AdditionalEnrollees
    display:
      v: Additional enrollees this approval period

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: check-box
      display:
        v: Check-box
    text:
      v: Check-box
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation
  value:
    v: vertical
link id:
  v: cr3.2.2.8
text:
  v: Students
type:
  v: choice
required:
  v: false
repeats:
  v: true
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: PreviousAccrual
    display:
      v: Previous Accrual
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: AdditionalEnrollees
    display:
      v: Additional enrollees this approval period

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: check-box
      display:
        v: Check-box
    text:
      v: Check-box
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation
  value:
    v: vertical
link id:
  v: cr3.2.2.9
text:
  v: Other
type:
  v: choice
required:
  v: false
repeats:
  v: true
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: PreviousAccrual
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link id:
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text:
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type:
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extension:
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    text:
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link id:
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text:
  v: Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests. (CIOMS)
type:
  v: display

link id:
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    value:
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type:
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item:
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      value:
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      value: Coding
    answer option:
      value: Coding
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        v: Indicator of benefits to participants
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    answer option:
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      v: If yes, please summarize the withdrawals:
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        v: cr4.5.4
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    type:
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    required:
      v: false
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      value: Coding
    answer option:
      value: Coding
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        v: literature published related to the risks or benefits associated with this research
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      v: If yes, please summarize relevance to study:
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v: color:#5caf42; font-size: 115%; font-weight:bold

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v: Drop down

v: Y

v: Yes

v: N

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v: Yes

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v: Yes

v: N

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v: Y

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

v: Drop down

v: Y

v: Yes

v: N

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CodeableConcept
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  code:
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  display:
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text:
  v: Help-Button

v: Y

v: false

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
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    coding:
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        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: drop-down
      display:
        v: Drop down
    text:
      v: Drop down
link id:
  v: cr4.5.10
text:
  v: Have there been any interim findings?
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:
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    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
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link id:
  v: cr4.5.11
text:
  v: If yes, please summarize findings:
type:
  v: text
enable when:
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    v: cr4.5.10
  operator:
    v: =
  answer: Coding
    system:
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    code:
      v: Y
required:
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    coding:
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        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: drop-down
      display:
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    text:
      v: Drop down
link id:
  v: cr4.5.12
text:
  v: Have there been any multi-center trial reports?
type:
  v: choice
required:
  v: false
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
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      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: cr4.5.13
text:
  v: If yes, please summarize findings and recommendations
type:
  v: text
enable when:
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    v: cr4.5.12
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
required:
  v: false
repeats:
  v: false
read only:
  v: false

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
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    coding:
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        v: http://hl7.org/fhir/questionnaire-item-control
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        v: drop-down
      display:
        v: Drop down
    text:
      v: Drop down
link id:
  v: cr4.5.14
text:
  v: Have there been any data safety monitoring board reports?
type:
  v: choice
required:
  v: false
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
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    display:
      v: Yes
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
      v: No

link id:
  v: cr4.5.15
text:
  v: If yes, please summarize findings and recommendations:
type:
  v: text
enable when:
  question:
    v: cr4.5.14
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
required:
  v: false

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
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        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: drop-down
      display:
        v: Drop down
    text:
      v: Drop down
link id:
  v: cr4.5.16
text:
  v: In the opinion of the Principal Investigator, have the risks or potential benefits changed?
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: cr4.5.17
text:
  v: If yes, please summarize the changes:
type:
  v: text
enable when:
  question:
    v: cr4.5.16
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
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: drop-down
      display:
        v: Drop down
    text:
      v: Drop down
link id:
  v: cr4.5.18
text:
  v: Has an audit of the research been conducted by a federal agency or sponsor?
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
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      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: drop-down
      display:
        v: Drop down
    text:
      v: Drop down
link id:
  v: cr4.5.19
text:
  v: Have there been any presentations or publications (including abstracts) from this 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

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
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        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: drop-down
      display:
        v: Drop down
    text:
      v: Drop down
link id:
  v: cr4.5.20
text:
  v: Have there been any substantial changes to the study (protocol, consent forms, or other study documents) or to the risk-benefit assessment?
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: cr4.5.21
text:
  v: If yes, please summarize the changes:
type:
  v: text
enable when:
  question:
    v: cr4.5.20
  operator:
    v: =
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    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
required:
  v: false

extension:
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    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: cr4.5.22
text:
  v: Was informed consent obtained from all enrolled participants?
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:
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      v: Drop down
link id:
  v: cr4.5.23
text:
  v: Has there been any other relevant information regarding this protocol?
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: cr4.5.24
text:
  v: If yes, please summarize:
type:
  v: text
enable when:
  question:
    v: cr4.5.23
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
required:
  v: false

link id:
  v: cr5
text:
  v: Adverse Events
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#274e90; font-size: 150%
type:
  v: group
required:
  v: false
item:
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      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
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        v: Help-Button
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    v: Any adverse events (medical and/or non-medical) during the previous continuing review period (or since the study inception for an initial report)
  type:
    v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
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  text:
    v: Have there been any internal or local adverse events in the research?
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      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
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      display:
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      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
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      display:
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  link id:
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    v: Did these adverse events occur at the frequency and level of severity expected?
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      v: cr5.1
    operator:
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        v: http://terminology.hl7.org/CodeSystem/v2-0532
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      code:
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item:
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    v: If no, please explain:
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      system:
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      code:
        v: N
  required:
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item:
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  link id:
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    v: Have any protocol deviations or violations occurred in this study?
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    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:
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    v: cr5.13
  text:
    v: If yes, please describe the protocol deviations or violations
  type:
    v: text
  enable when:
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      v: cr5.3
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  required:
    v: false

v: help

v: Help-Button

v: drop-down

v: Drop down

v: drop-down

v: Drop down

v: drop-down

v: Drop down

link id:
  v: cr6
text:
  v: Conflict of Interest
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#274e90; font-size: 150%
type:
  v: group
required:
  v: false
item:
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      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
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    v: Has there been a change in the financial disclosure status of the Principal Investigator or other members of the Research Staff that has not been reported to the IRB?
  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:
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      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
item:
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    v: If yes, please explain:
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    v: text
  enable when:
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    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  required:
    v: false

v: drop-down

v: Drop down

link id:
  v: cr17
text:
  v: 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:
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item:
  link id:
    v: cr17.1
  text:
    v: Describe the file that is being attached (optional)
  type:
    v: string
item:
  link id:
    v: cr17.2
  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: cr17_help
  text:
    v: Attachments related to the Continuing Review can be included here. Examples are a DSMB report or an Adverse Event Report (Medical or Non-Medical).
  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: cr
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