sirb-protocol-questionnaire-populate
type: Questionnaire
node role: treeRoot
id:
  v: sirb-protocol-questionnaire-populate
text:
  status:
    v: generated
  div: Structure LinkId Text Cardinality Type Flags Description & Constraints Protocol_questionnaire Questionnaire http://hl7.org/fhir/us/sirb/Questionnaire/sirb-protocol-questionnaire-populate#1.0.0 p1 Research Study 0..1 group p1.1 Study Type 1..1 choice Options: 2 options Expressions: Calculated Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.4').answer.valueCoding p1.1_help Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional) 0..1 display p1.2 Intervention 1..1 choice Enable When: p1.1 = Interventional (Temporary Codes#INT) Options: 4 options p1.2_help A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise. 0..1 display p1.3 Does this protocol require a FDA exemption? 0..1 choice Enable When: p1.2 = Drug/Biologic/Vaccine (Temporary Codes#DBV) p1.2 = Device (Temporary Codes#DEV) Options: 2 options Expressions: Calculated Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.1').answer.valueCoding p1.30 Is an IND or IDE being used in this study? 0..1 choice Enable When: p1.3 = Yes (expandedYes-NoIndicator#Y) Options: 2 options Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.2').answer.valueCoding p1.30_help Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used? 0..1 display p1.4 Type of exemption 0..1 choice Enable When: p1.3 = Yes (expandedYes-NoIndicator#Y) Options: 2 options Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.4').answer.valueCoding p1.4_help Select Investigational New Drug (IND) or Investigational Device Exemption (IDE) 0..1 display p1.5 Study Title 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = '…
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: type of exemption IND or IDE
    name:
      v: typeExemptionIDEIDN
    language:
      v: text/fhirpath
    expression:
      v: %resource.item.item.where(linkId = 'p1.4').answer.value.code
url:
  v: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-protocol-questionnaire-populate
version:
  v: 1.0.0
name:
  v: Protocol_questionnaire
title:
  v: Protocol 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: p1
  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/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: p1.1
    text:
      v: Study Type
    type:
      v: choice
    required:
      v: true
    answer option:
      value: Coding
    answer option:
      value: Coding
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p1.1_help
      text:
        v: Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p1.2
    text:
      v: Intervention
    type:
      v: choice
    enable when:
      question:
        v: p1.1
      operator:
        v: =
      answer: Coding
    required:
      v: true
    repeats:
      v: false
    read only:
      v: false
    answer option:
      value: Coding
    answer option:
      value: Coding
    answer option:
      value: Coding
    answer option:
      value: Coding
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p1.2_help
      text:
        v: A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: p1.3
    text:
      v: Does this protocol require a FDA exemption?
    type:
      v: choice
    enable when:
      question:
        v: p1.2
      operator:
        v: =
      answer: Coding
    enable when:
      question:
        v: p1.2
      operator:
        v: =
      answer: Coding
    enable behavior:
      v: any

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

v: Drop down

v: text/fhirpath

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

v: INT

v: Interventional

v: OBS

v: Observational

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

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

v: Drop down

v: INT

v: DBV

v: Drug/Biologic/Vaccine

v: DEV

v: Device

v: SBE

v: Social/Behavioral/educational (SBE)

v: PRO

v: Procedural

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

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

v: Drop down

v: text/fhirpath

v: %lookupInitiateStudy.descendants().where(linkId = 'in9.1').answer.valueCoding

v: DBV

v: DEV

v: false

v: false

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: drop-down
      display:
        v: Drop down
    text:
      v: Drop down
extension:
  url:
    v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: %lookupInitiateStudy.descendants().where(linkId = 'in9.2').answer.valueCoding
link id:
  v: p1.30
text:
  v: Is an IND or IDE being used in this study?
type:
  v: choice
enable when:
  question:
    v: p1.3
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
required:
  v: false
repeats:
  v: false
read only:
  v: false
answer option:
  value: Coding
    system:
      v: http://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: p1.30_help
  text:
    v: Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?
  type:
    v: display

v: help

v: Help-Button

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: drop-down
      display:
        v: Drop down
    text:
      v: Drop down
extension:
  url:
    v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: %lookupInitiateStudy.descendants().where(linkId = 'in9.4').answer.valueCoding
link id:
  v: p1.4
text:
  v: Type of exemption
type:
  v: choice
enable when:
  question:
    v: p1.3
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
required:
  v: false
repeats:
  v: false
read only:
  v: false
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: IND
    display:
      v: IND
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: IDE
    display:
      v: IDE
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: p1.4_help
  text:
    v: Select Investigational New Drug (IND) or Investigational Device Exemption (IDE)
  type:
    v: display

v: help

v: Help-Button

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 = 'in1.1').answer.value
link id:
  v: p1.5
text:
  v: Study Title
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: p1.5_help
  text:
    v: The official title of a protocol used to identify a clinical study.Include phase (e.g. pilot proof of concept study, phase I, phase II, etc.), design (e.g. randomized, double blind, placebo controlled, etc.), if the study is multi-center, the investigational agent (drug, device, biologic, vaccine, procedural and/or behavioral etc., and target disease(s)
  type:
    v: display

v: help

v: Help-Button

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 = 'in1.2').answer.value
link id:
  v: p1.6
text:
  v: Study Title (Short)
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: p1.6_help
  text:
    v: A short study title written in language intended for the lay public.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p1.61
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
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.descendants().where(linkId = 'in7.3.1').answer.value
  link id:
    v: p1.61.1
  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: p1.61.1_help
    text:
      v: First or given name of the lead principal investigator
    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.descendants().where(linkId = 'in7.3.2').answer.value
  link id:
    v: p1.61.2
  text:
    v: Last Name
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p1.61.2_help
    text:
      v: Surname or family name
    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.descendants().where(linkId = 'in7.3.3').answer.value
  link id:
    v: p1.61.7
  text:
    v: Suffix
  type:
    v: string
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p1.61.7_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
      language:
        v: text/fhirpath
      expression:
        v: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value
  link id:
    v: p1.61.8
  text:
    v: Degree(s)
  type:
    v: string
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p1.61.8_help
    text:
      v: Professional and Academic degrees of the lead principal investigator
    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.descendants().where(linkId = 'in7.3.10').answer.value
  link id:
    v: p1.61.3
  text:
    v: Department Name
  type:
    v: string
  required:
    v: false
item:
  link id:
    v: p1.61.4
  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
    link id:
      v: p1.61.4.1
    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: p1.61.4.2
    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: p1.61.4.3
    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

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: text/fhirpath

v: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.1').answer.value

v: text/fhirpath

v: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.2').answer.value

v: text/fhirpath

v: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.3').answer.value

Expression
language:
  v: text/fhirpath
expression:
  v: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.4').answer.value

v: p1.61.4.4

v: Zip Code

v: string

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 = 'in7.3.7.5').answer.value
link id:
  v: p1.61.4.5
text:
  v: Country
type:
  v: string
required:
  v: false
repeats:
  v: false
read only:
  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 = 'in7.3.5').answer.value
link id:
  v: p1.61.5
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: p1.61.5_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-initialExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value
link id:
  v: p1.61.6
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: p1.61_help
text:
  v: The individual(s) designated by the applicant organization/recipient to have the appropriate level of authority and responsibility to direct the project or program to be supported by the award. The applicant organization may designate multiple individuals as program directors/principal investigators (PD/PIs) who share the authority and responsibility for leading and directing the project, intellectually and logistically. When multiple PD/PIs are named, each is responsible and accountable to the official(s) at the applicant organization/recipient, or as appropriate, to a collaborating organization for the proper conduct of the project, program, or activity including the submission of all required reports. The presence of more than one PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI. (NIH Definition). https://grants.nih.gov/grants/policy/nihgps/html5/section_1/1.2_definition_of_terms.htm
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-xhtml
    value:
      v: The individual(s) designated by the applicant organization/recipient to have the appropriate level of authority and responsibility to direct the project or program to be supported by the award. The applicant organization may designate multiple individuals as program directors/principal investigators (PD/PIs) who share the authority and responsibility for leading and directing the project, intellectually and logistically. When multiple PD/PIs are named, each is responsible and accountable to the official(s) at the applicant organization/recipient, or as appropriate, to a collaborating organization for the proper conduct of the project, program, or activity including the submission of all required reports. The presence of more than one PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI. (NIH Definition). https://grants.nih.gov/grants/policy/nihgps/html5/section_1/1.2_definition_of_terms.htm
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: p1.7
text:
  v: Additional Investigator
type:
  v: choice
required:
  v: false
repeats:
  v: false
read only:
  v: false
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
    display:
      v: Yes
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
      v: No
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: p1.7_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

v: help

v: Help-Button

link id:
  v: p1.8
text:
  v: Additional Investigator
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#2a623d; font-size: 125%
type:
  v: group
enable when:
  question:
    v: p1.7
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
required:
  v: false
repeats:
  v: true
read only:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: p1.8.1
  text:
    v: Additional Investigator Role
  type:
    v: open-choice
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: COPI
      display:
        v: Co-Principal Investigator
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: COI
      display:
        v: Co-Investigator
  answer option:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: PD
      display:
        v: Program Director
item:
  link id:
    v: p1.8.2
  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: p1.8.2_help
    text:
      v: First or given name of the additional investigator
    type:
      v: display
item:
  link id:
    v: p1.8.3
  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: p1.8.3_help
    text:
      v: Surname or family name
    type:
      v: display
item:
  link id:
    v: p1.8.8
  text:
    v: Suffix
  type:
    v: string
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p1.8.8_help
    text:
      v: Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.
    type:
      v: display
item:
  link id:
    v: p1.8.9
  text:
    v: Degree(s)
  type:
    v: string
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p1.8.9_help
    text:
      v: Professional and Academic degrees of the additional investigator
    type:
      v: display
item:
  link id:
    v: p1.8.4
  text:
    v: Department Name
  type:
    v: string
  required:
    v: false
item:
  link id:
    v: p1.8.5
  text:
    v: Address
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: p1.8.5.1
    text:
      v: Street Address
    type:
      v: string
    required:
      v: false
  item:
    link id:
      v: p1.8.5.2
    text:
      v: City
    type:
      v: string
    required:
      v: false
  item:
    link id:
      v: p1.8.5.3
    text:
      v: State
    type:
      v: string
    required:
      v: false

v: drop-down

v: Drop down

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

v: Help-Button

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: p1.8.5.4
text:
  v: Zip Code
type:
  v: string
required:
  v: false

link id:
  v: p1.8.5.5
text:
  v: Country
type:
  v: string
required:
  v: false
repeats:
  v: false
read only:
  v: false

link id:
  v: p1.8.6
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: p1.8.6_help
  text:
    v: 10-digit phone number, including area code
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p1.8.7
text:
  v: Email
type:
  v: string
required:
  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 = 'in1.3').answer.value
link id:
  v: p1.9
text:
  v: IRB Protocol Number
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: p1.9_help
  text:
    v: Provided by the sIRB. Will not be available at the time of initial submission.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p1.10
text:
  v: Sponsor Name(s) and Protocol Number
  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-initialExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'SFS').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_p1.10.1.1
  text:
    v: External Data For linkId p1.10.1.1
  type:
    v: open-choice
  required:
    v: false
  repeats:
    v: true
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/variable
    value: Expression
      description:
        v: Sponsor Selected for this repetition of the repeating group
      name:
        v: sponsorSelectedThisRepetition
      language:
        v: text/fhirpath
      expression:
        v: item.where(linkId = 'p1.10.1.1').answer.valueCoding.display
  link id:
    v: p1.10.1
  text:
    v: Sponsor
  type:
    v: group
  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: p1.10.1.1
    text:
      v: Sponsor Name
    type:
      v: open-choice
    required:
      v: false
  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-calculatedExpression
      value: Expression
    link id:
      v: p1.10.1.2
    text:
      v: Sponsor Protocol Number
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p1.10.1.2_help
      text:
        v: Unique Protocol Identification Number used by the sponsor.
      type:
        v: display

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_p1.10.1.1').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: %lookupInitiateStudy.item.where(linkId = 'in5' and item.where(answer.valueString = %sponsorSelectedThisRepetition)).item.where(linkId = 'in5.4').answer.valueString

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: p1.11
text:
  v: ClinicalTrials.Gov Identifier
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: p1.11_help
  text:
    v: The unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419).
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p1.12
text:
  v: Grant Title
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: p1.12_help
  text:
    v: Funding Opportunity Title
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p1.13
text:
  v: NIH Grant Number
type:
  v: text
required:
  v: false

extension:
  url:
    v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: iif(%typeExemptionIDEIDN = 'IND', %lookupInitiateStudy.descendants().where(linkId = 'in9.3').answer.value)
link id:
  v: p1.14
text:
  v: IND Number
type:
  v: string
enable when:
  question:
    v: p1.4
  operator:
    v: =
  answer: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: IND
required:
  v: false

extension:
  url:
    v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: iif(%typeExemptionIDEIDN = 'IDE', %lookupInitiateStudy.descendants().where(linkId = 'in9.3').answer.value)
link id:
  v: p1.15
text:
  v: IDE Number
type:
  v: string
enable when:
  question:
    v: p1.4
  operator:
    v: =
  answer: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: IDE
required:
  v: false

link id:
  v: p1.16
text:
  v: Study Product Name
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: p1.16_help
  text:
    v: Generic, followed by marketed name if applicable
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p1.17
text:
  v: Study Product Provider
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: p1.17_help
  text:
    v: e.g. NIH, or company
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p1.18
text:
  v: Funding Organization(s), Address and 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-initialExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'SFS').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_p1.18.1.1
  text:
    v: External Data For linkId p1.18.1.1
  type:
    v: open-choice
  required:
    v: false
  repeats:
    v: true
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/variable
    value: Expression
      description:
        v: name of the funding organization
      name:
        v: fundingOrgName
      language:
        v: text/fhirpath
      expression:
        v: item.where(linkId = 'p1.18.2.1').answer.valueCoding.display
  link id:
    v: p1.18.1
  text:
    v: Funding Organization
  type:
    v: group
  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: p1.18.1.1
    text:
      v: Name
    type:
      v: open-choice
    required:
      v: false
  item:
    link id:
      v: p1.18.1.2
    text:
      v: Address
    type:
      v: group
    required:
      v: false
    repeats:
      v: false
    read only:
      v: false
    item:
      link id:
        v: p1.18.1.2.1
      text:
        v: Street Address
      type:
        v: string
      required:
        v: false
    item:
      link id:
        v: p1.18.1.2.2
      text:
        v: City
      type:
        v: string
      required:
        v: false
      repeats:
        v: false
      read only:
        v: false
    item:
      link id:
        v: p1.18.1.2.3
      text:
        v: State
      type:
        v: string
      required:
        v: false
    item:
      link id:
        v: p1.18.1.2.4
      text:
        v: Zip Code
      type:
        v: string
      required:
        v: false
    item:
      link id:
        v: p1.18.1.2.5
      text:
        v: Country
      type:
        v: string
      required:
        v: false
      repeats:
        v: false
      read only:
        v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
      value: Expression
    link id:
      v: p1.18.1.5
    text:
      v: Phone
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p1.18.1.5_help
      text:
        v: 10-digit phone number, including area code
      type:
        v: display
  item:
    link id:
      v: p1.18.1.4
    text:
      v: Email
    type:
      v: string
    required:
      v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: p1.18_help
  text:
    v: e.g. NIH, or company
  type:
    v: display

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_p1.18.1.1').answer.value

v: text/fhirpath

v: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in5.2' and answer.value = %fundingOrgName)).item.where(linkId = 'in5.3').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: help

v: Help-Button

link id:
  v: p1.19
text:
  v: Sponsor(s), Address and 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-initialExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'SFS').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_p1.19.1.1
  text:
    v: External Data For linkId p1.19.1.1
  type:
    v: open-choice
  required:
    v: false
  repeats:
    v: true
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/variable
    value: Expression
      description:
        v: name of the sponsor organization
      name:
        v: sponsorOrgNameSelectedThisRepetition
      language:
        v: text/fhirpath
      expression:
        v: item.where(linkId = 'p1.19.1').answer.valueCoding.display
  link id:
    v: p1.19.1
  text:
    v: Sponsor
  type:
    v: group
  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: p1.19.1.1
    text:
      v: Name
    type:
      v: open-choice
    required:
      v: false
  item:
    link id:
      v: p1.19.1.2
    text:
      v: Department Name
    type:
      v: string
    required:
      v: false
  item:
    link id:
      v: p1.19.1.3
    text:
      v: Address
    type:
      v: group
    required:
      v: false
    repeats:
      v: false
    read only:
      v: false
    item:
      link id:
        v: p1.19.1.3.1
      text:
        v: Street Address
      type:
        v: string
      required:
        v: false
    item:
      link id:
        v: p1.19.1.3.2
      text:
        v: City
      type:
        v: string
      required:
        v: false
    item:
      link id:
        v: p1.19.1.3.3
      text:
        v: State
      type:
        v: string
      required:
        v: false
    item:
      link id:
        v: p1.19.1.3.4
      text:
        v: Zip Code
      type:
        v: string
      required:
        v: false
    item:
      link id:
        v: p1.19.1.3.5
      text:
        v: Country
      type:
        v: string
      required:
        v: false
      repeats:
        v: false
      read only:
        v: false
  item:
    link id:
      v: p1.19.1.4
    text:
      v: Email
    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: p1.19.1.5
    text:
      v: Phone
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p1.19.1.5_help
      text:
        v: 10-digit phone number, including area code
      type:
        v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: p1.19_help
  text:
    v: Individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization taking responsibility for and investing in a clinical investigation.

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_p1.19.1.1').answer.value

v: text/fhirpath

v: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in5.2' and answer.value = %sponsorOrgNameSelectedThisRepetition)).item.where(linkId = 'in5.3').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: help

v: Help-Button

v: display

link id:
  v: p1.20
text:
  v: Medical Monitor
  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: Help-Button
  link id:
    v: p1.20_help
  text:
    v: Medical expert for the clinical trial
  type:
    v: display
item:
  link id:
    v: p1.20.1
  text:
    v: First Name
  type:
    v: string
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p1.20.1_help
    text:
      v: First or given name of the medical monitor
    type:
      v: display
item:
  link id:
    v: p1.20.2
  text:
    v: Last Name
  type:
    v: string
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p1.20.2_help
    text:
      v: Surname or family name
    type:
      v: display
item:
  link id:
    v: p1.20.6
  text:
    v: Suffix
  type:
    v: string
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p1.20.6_help
    text:
      v: Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.
    type:
      v: display
item:
  link id:
    v: p1.20.7
  text:
    v: Degree(s)
  type:
    v: string
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p1.20.7_help
    text:
      v: Professional and Academic degrees of the medical monitor
    type:
      v: display
item:
  link id:
    v: p1.20.3
  text:
    v: Phone
  type:
    v: string
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p1.20.3_help
    text:
      v: 10-digit phone number, including area code
    type:
      v: display
item:
  link id:
    v: p1.20.4
  text:
    v: Email
  type:
    v: string
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
item:
  link id:
    v: p1.20.5
  text:
    v: Address
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: p1.20.5.1
    text:
      v: Street Address
    type:
      v: string
    required:
      v: false
    repeats:
      v: false
    read only:
      v: false
  item:
    link id:
      v: p1.20.5.2
    text:
      v: City
    type:
      v: string
    required:
      v: false
    repeats:
      v: false
    read only:
      v: false
  item:
    link id:
      v: p1.20.5.3
    text:
      v: State
    type:
      v: text
    required:
      v: false

v: help

v: Help-Button

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

v: Help-Button

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

v: Help-Button

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

v: Help-Button

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: p1.20.5.4
text:
  v: Zip Code
type:
  v: string
required:
  v: false
repeats:
  v: false
read only:
  v: false

link id:
  v: p1.20.5.5
text:
  v: Country
type:
  v: string
required:
  v: false
repeats:
  v: false
read only:
  v: false

link id:
  v: p1.21
text:
  v: Confidentialty Statement
type:
  v: text
required:
  v: false

link id:
  v: p1.23
text:
  v: Protocol Version Number
type:
  v: string
required:
  v: false
repeats:
  v: false
read only:
  v: false

link id:
  v: p1.24
text:
  v: Protocol Version Date
type:
  v: date
required:
  v: false
repeats:
  v: false
read only:
  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: gtable
      display:
        v: Group Table
    text:
      v: Group Table
link id:
  v: p2
text:
  v: Protocol Amendment Summary of Changes Table
  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: p2.1
  text:
    v: Affected Section(s)
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p2.2
  text:
    v: Summary of Revisions Made
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p2.3
  text:
    v: Rationale
  type:
    v: text
  required:
    v: false

link id:
  v: p2.4
text:
  v: Statement of Compliance
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color: #274e90; font-size: 150%
type:
  v: text
required:
  v: true
repeats:
  v: false
read only:
  v: false
initial:
  value:
    v: [Choose Sample Text] (1) [The trial will be carried out in accordance with International Conference on Harmonisation Good Clinical Practice (ICH GCP) and the following: United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812) National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible for the conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects Protection and ICH GCP Training. The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the Institutional Review Board (IRB) for review and approval. Approval of both the protocol and the consent form must be obtained before any participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. In addition, all changes to the consent form will be IRB-approved; a determination will be made regarding whether a new consent needs to be obtained from participants who provided consent, using a previously approved consent form.] OR (2) [The trial will be conducted in accordance with International Conference on Harmonisation Good Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and the <specify NIH Institute or Center (IC) > Terms and Conditions of Award. The Principal Investigator will assure that no deviation from, or changes to the protocol will take place without prior agreement from the Investigational New Drug (IND) or Investigational Device Exemption (IDE) sponsor, funding agency and documented approval from the Institutional Review Board (IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. All personnel involved in the conduct of this study have completed Human Subjects Protection and ICH GCP Training. T…
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: p2.4_help
  text:
    v: Select one of the two statements below. If the study is an intramural NIH study, use the second statement below
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p3
text:
  v: Protocol Summary
  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:
  link id:
    v: p3.1
  text:
    v: Synopsis
    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
  read only:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression
      value: Expression
    link id:
      v: p3.1.1
    text:
      v: Title (Full)
    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: p3.1.2
    text:
      v: Title (Short)
    type:
      v: string
    required:
      v: false
  item:
    link id:
      v: p3.1.3
    text:
      v: Study Description
    type:
      v: text
    required:
      v: false
    repeats:
      v: false
    read only:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p3.1.3_help
      text:
        v: Short description of the protocol, including a brief statement of the study hypothesis. This should be only a few sentences in length. A detailed schematic describing all visits and a schedule of assessments should be included in the Schema and Schedule of Activities
      type:
        v: display
  item:
    link id:
      v: p3.1.4
    text:
      v: Objectives
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p3.1.4_help
      text:
        v: Include the primary and secondary objectives.Theseobjectives should be thesame as the objectives contained in the body of the protocol. These align with Primary Purpose in clinicaltrials.gov
      type:
        v: display
  item:
    link id:
      v: p3.1.5
    text:
      v: End Points
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p3.1.5_help
      text:
        v: Primary endpoint and secondary endpoints.These endpoints should be the same as the endpoints contained in the body of the protocol. These align with Outcome Measures in clinicaltrials.gov
      type:
        v: display
  item:
    link id:
      v: p3.1.6
    text:
      v: Accrual Ceiling/Number of Participants (projected-for all sites)
    type:
      v: integer
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p3.1.6_help
      text:
        v: The total number of subjects expected to complete the study. This includes expected sample size and estimated ineligible persons after signing a screening consent.
      type:
        v: display
  item:
    link id:
      v: p3.1.7
    text:
      v: Study Population
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p3.1.7_help
      text:
        v: Specify sample size, gender, age, demographic group, general health status, and geographic location.
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p3.1.8
    text:
      v: Phase
    type:
      v: choice
    required:
      v: false
    repeats:
      v: false
    answer option:
      value: Coding
    answer option:
      value: Coding
    answer option:
      value: Coding
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p3.1.8_help
      text:
        v: Applies to drugs and biologics.
      type:
        v: display
  item:
    link id:
      v: p3.1.9
    text:
      v: Description of Sites/Facilities Enrolling Participants
    type:
      v: text
    required:
      v: false
    repeats:
      v: false
    read only:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p3.1.9_help

v: text/fhirpath

v: %resource.item.item.where(linkId = 'p1.5').answer.value

v: text/fhirpath

v: %resource.item.item.where(linkId = 'p1.6').answer.value

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

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

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

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

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

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

v: Drop down

v: phase-2

v: Phase 2

v: phase-3

v: Phase 3

v: phase-4

v: Phase 4

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

v: Brief description of planned facilities/participating sites enrolling participants. Indicate number of sites and if the study is intended to include sites outside the United States.

v: display

link id:
  v: p3.1.10
text:
  v: Description of Study Intervention ( Agent/Procedure)/Investigational Product
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: p3.1.10_help
  text:
    v: Describe the study intervention. If the study interventionis a drug or biologic, include dose and route of administration. For devices,provide a description ofeach important component, ingredient,property and the principle of operation of the device.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p3.1.11
text:
  v: Study Duration
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: p3.1.11_help
  text:
    v: Estimated time (in months) from when the study opens to enrollment until completion of data analyses
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p3.1.12
text:
  v: Participant Duration
type:
  v: text
required:
  v: false
repeats:
  v: false
read only:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: p3.1.12_help
  text:
    v: Time (e.g., in months) it will take for each individual participant to complete all participant visits.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p3.1.13
text:
  v: Methodology
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: p3.1.13_help
  text:
    v: Design attributes such as single blind, double blind or open label; Randomized, placebo or active placebo control; cross-over design, etc.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p3.1.14
text:
  v: Duration of Investigational Product Administration
type:
  v: text
enable when:
  question:
    v: p1.1
  operator:
    v: =
  answer: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: INT
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: p3.1.14_help
  text:
    v: Total duration of investigational product administration (including any open-label lead-in, if applicable).
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p3.1.15
text:
  v: Key Procedures
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: p3.1.15_help
  text:
    v: Procedures that are required for the study (e.g. harvesting of tumor, vaccine, tumor biopsy and blood draws)
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p3.1.16
text:
  v: Main Inclusion/Exclusion Criteria
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: p3.1.16_help
  text:
    v: Entire list of inclusion and exclusion criteria will appear later in the protocol. Only include the key inclusion and exclusion criteria in this section.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p3.1.17
text:
  v: Reference Therapy
type:
  v: text
enable when:
  question:
    v: p1.1
  operator:
    v: =
  answer: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: INT
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: p3.1.17_help
  text:
    v: Note if there is a standard reference therapy against which the investigational product is being compared, or if the reference is a placebo
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p3.1.18
text:
  v: Statistical Analysis
type:
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required:
  v: false
repeats:
  v: false
read only:
  v: false
item:
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      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
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    v: A very brief description of the main elements of the statistical methodology to be used in the study. Limit this section to discussion of the analysis of the primary endpoint and perhaps the main secondary endpoint.
  type:
    v: display

v: help

v: Help-Button

link id:
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text:
  v: Schema
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    value:
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repeats:
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    v: Attach schema here
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  repeats:
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item:
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    v: This section is optional. If a schematic is used, it should provide a quick "snapshot" of the study and ideally be limited to one page. Please see the NIH Protocol Templates for Clinical Trials page for the protocol template which contains examples of schematics. A schematic shows the level of detail needed to convey an overview of study design with study-specific information about the study design (e.g., changing method of assignment to study group, adding study arms, visits, etc.) The time point(s) indicated in the schematic should correspond to the time point(s) in Section 7.3, the Study Schedule, e.g., Visit 1, Day 0; Visit 2, Day 30 +/- 7; etc.
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      value:
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v: help

v: Help-Button

link id:
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text:
  v: Schedule of Activities
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    v: Schedule of Activities
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      value: CodeableConcept
    link id:
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      v: Describe the schedule of activities in the text box here or attach a copy of the Schedule of Activities below.
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  text:
    v: Schedule of Activities Attachment
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    value: CodeableConcept
      text:
        v: Help-Button
  link id:
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    v: The schedule of activities must capture the procedures that will be accomplished at each study visit, and all contact, with study participants e.g., telephone contacts. This includes any tests that are used for eligibility, participant randomization or stratification, or decisions on study intervention discontinuation. Only include procedures that contribute to participant eligibility and study objectives and endpoints. Other procedures should be done sparingly and with consideration, as they may add unnecessary complexity and detract from recruitment. Either describe in the text box here or attach a copy of the Schedule of Activities.
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code:
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v: Help-Button

v: help

v: Help-Button

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item:
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      value:
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      v: Describe the relevant literature and the specific gaps in current knowledge that this study intends to address
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    required:
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    item:
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      link id:
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        v: Gaps that this study intends to address based on literature
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      v: Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how it will add to existing knowledge
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    required:
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      link id:
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        v: Based on the existing literature and how it will add to existing knowledge
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      v: Describe the relevance and usefulness of the objectives
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    required:
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      value: CodeableConcept
    link id:
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    text:
      v: Is this the first time the study drug, device, or intervention/procedure will be used in humans.
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    required:
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    answer option:
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    answer option:
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      v: If there has been experience with the study drug, device, or intervention/procedure in humans, detail the experience to date
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    enable when:
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      operator:
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      answer: Coding
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    repeats:
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    read only:
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      link id:
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        v: Details If the intervention/drug/device is not the first time used.
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      v: Investigational Product
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      operator:
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      answer: Coding
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        v: In this section include the name and description of the study intervention (drug, device, biologic, etc.) This section should contain a description of the investigational agent, its make-up, chemical properties and any relevant physical properties, including any available pharmacologic data.Specify the FDA approval status and include the IND Number or justify how the drug meets the IND Exemption criteria if applicable.For device studies this section should include a description of the device, including category of the device, and overview of its intended use or purpose in the research study. Specify the FDA approval status and include the IDE Number or Non-Significant Risk rationale if applicable.
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        v: display
    item:
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      text:
        v: Name and Description
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      repeats:
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        v: Preclinical Data
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      repeats:
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        v: Clinical Data to Date
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    link id:
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      v: Is there an active control group?
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    answer option:
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v: Y

v: Yes

v: N

v: No

v: N

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v: Human Pharmacokinetics

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v: false

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v: p4.1.6.3.3

v: Clinical Studies in Children

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v: false

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v: Drop down

v: Y

v: Yes

v: N

v: No

link id:
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text:
  v: Active Control Group
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    v: Describe any potential bias in the selection of the active control such that there will be an unfair advantage for the investigational intervention. For example, is the active control treatment known to be significantly less effective in this study population than another treatment
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  required:
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item:
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    value: CodeableConcept
      text:
        v: Drop down
  link id:
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    v: Is the sample size and the randomization ratio for this active control study ethically justified with regard to the number of participants who will be exposed to the risks of the study.
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      code:
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      display:
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      system:
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      code:
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      display:
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      text:
        v: Drop down
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    v: Is the active control an established effective intervention?
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      code:
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      display:
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  answer option:
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      code:
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  link id:
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    v: If no, clarify how it is ethically justified to use this control in the study
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      code:
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v: drop-down

v: Drop down

v: drop-down

v: Drop down

link id:
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text:
  v: Study Rationale
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required:
  v: false
item:
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      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
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    v: The problems or question and reason for conducting the study. E.g. explain the population, disease, standard of care (if there is one), and limitations of knowledge or available therapy.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p4.3
text:
  v: Risk/Benefit Assessment
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    value:
      v: color:#2a623d; font-size: 125%
type:
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item:
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  text:
    v: Potential Risks
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  required:
    v: false
  item:
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      v: List the reasonably foreseeable risks, discomforts, hazards, and/or inconveniences to the participants related to their participation in the research, including risk of unintentional loss of confidentiality. Include a description of the probability, magnitude, duration, reversibility, and potential consequences of the risks. Consider physical, psychological, social, legal, and economic risks
    type:
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    required:
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  item:
    link id:
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    text:
      v: State which study interventions may have unknown risks
    type:
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    required:
      v: false
  item:
    link id:
      v: p4.3.1.3
    text:
      v: State which study interventions may have risks to an embryo or fetus (if a participant is or becomes pregnant) or to a nursing infant of a study participant
    type:
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    required:
      v: false
  item:
    link id:
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    text:
      v: Describe risks to people other than the participating participant, e.g., risks to family members, friends, others or risks to the community
    type:
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    required:
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  item:
    extension:
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        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
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    text:
      v: Are there any risks to study investigators or staff performing the study procedures due to research with high risk populations (e.g. prisoners, intravenous drug users, patients with major psychiatric issues, etc.):?
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    required:
      v: false
    answer option:
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    answer option:
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    text:
      v: Risks to study investigators or staff performing the study procedures due to research with high risk populations (e.g. prisoners, intravenous drug users, patients with major psychiatric issues, etc.)
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      v: group
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      operator:
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      answer: Coding
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        v: Describe these risks
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      required:
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    item:
      link id:
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        v: Describe the procedures that will be put in place to minimize these risks
      type:
        v: text
      required:
        v: false
    item:
      link id:
        v: p4.3.1.6.3
      text:
        v: Describe how these procedures are adequate for the location where study procedures will be performed
      type:
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      required:
        v: false
  item:
    link id:
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    text:
      v: Other risks
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    required:
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    repeats:
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    read only:
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item:
  link id:
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    v: Potential Benefits
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  repeats:
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    link id:
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      v: Describe the potential benefits that individual participants may experience from taking part in the research. Include the probability, magnitude, and duration of the potential benefits
    type:
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    required:
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        v: Note: Payments and incentives are not considered benbefits.
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        v: display
  item:
    link id:
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      v: Describe any benefit to the population from which the participant is drawn
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    required:
      v: false
  item:
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    text:
      v: Describe any benefit to science, society, and humanity in general
    type:
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    required:
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  item:
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      v: Other benefits
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    required:
      v: false
item:
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    v: Alternatives to Study Participation
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    v: group
  required:
    v: false
  item:
    link id:
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    text:
      v: Describe alternatives to participating in this research study (e.g. to decide not participate in the study, alternative treatments, no treatment (palliative care), etc.)

system:
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v: Drop down

v: Y

v: Yes

v: N

v: No

v: Y

CodeableConcept
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v: text

v: false

link id:
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text:
  v: Describe the standard clinical care that may be an alternative
type:
  v: text
required:
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link id:
  v: p4.3.3.3
text:
  v: Describe how the participant can receive the research procedures/drug/device used in this study in a non-research setting
type:
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required:
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link id:
  v: p4.3.3.4
text:
  v: Other alternatives to study participation
type:
  v: text
required:
  v: false
repeats:
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read only:
  v: false

link id:
  v: p5
text:
  v: Study Purpose, Objectives or Specific Aims
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    value:
      v: color: #274e90; font-size: 150%
type:
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  v: false
item:
  link id:
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    v: Describe the purpose, specific aims, or objectives of the study
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    v: display
item:
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    v: p5.1
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    v: Hypothesis
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    v: text
  required:
    v: false
item:
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    v: Primary Objectives
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    v: text
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    v: false
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        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p5.2_help
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      v: The main question the study seeks to answer.
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      v: display
item:
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    v: Secondary Objectives
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    v: text
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    link id:
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      v: The secondary objective(s) are goals that will provide further information on the use of the intervention.
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      v: display
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    v: Tertiary/Exploratory Objectives
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        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
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    link id:
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      v: Tertiary/exploratory objective(s) serve as a basis for explaining or supporting findings of primary analyses and for suggesting further hypotheses for later research.
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  v: Help-Button

v: Help-Button

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  v: Help-Button

v: Help-Button

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  v: Help-Button

v: Help-Button

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  v: Study Endpoints
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    v: Precise definitions of the study endpoints and criteria for evaluation
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    v: display
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    v: Primary Endpoints
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    v: text
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        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
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      v: Description of primary endpoints identified in the primary Study Protocol.
    type:
      v: display
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item:
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  read only:
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  read only:
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item:
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  read only:
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item:
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system:
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v: Help-Button

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v: Help-Button

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v: Help-Button

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v: Help-Button

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v: false

v: true

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type:
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link id:
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text:
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type:
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link id:
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text:
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link id:
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text:
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    value:
      v: color: #274e90; font-size: 150%
type:
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item:
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  item:
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    repeats:
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    read only:
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text:
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v: false

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v: Do the study interventions or procedures hold out the prospect of direct benefit for the woman or the fetus

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v: Describe benefit for the women or fetus

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v: If there is no prospect of benefit to the fetus, clarify whether the risk to the fetus is NOT greater than Minimal Risk, and whether the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means

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v: Describe the biomedical knowledge that is expected to result from this research for this population

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v: p9.1.7.2.8

v: Describe how any risk of this research is the least possible for achieving the objectives of the research

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v: p9.1.7.2.9

v: Describe how mothers providing consent are informed of the reasonably foreseeable impact of the research on the fetus or neonate

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v: false

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Coding
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Coding
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v: p9.1.7.31.1

v: Describe any preclinical and clinical studies that have been conducted that provide data for assessing potential risks to neonates

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v: p9.1.7.31.2

v: Describe the important biomedical knowledge that will be developed from this research and why it cannot be obtained by other means

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v: p9.1.7.31.3

v: Describe whether there will be added risk to the neonate resulting from the research

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v: false

v: false

v: false

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v: Describe how individuals providing consent are informed of the reasonably foreseeable impact of the research on the neonate

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v: false

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v: No person shall perform or offer to perform an abortion where part or all of the consideration for said performance is that the fetal remains may be used for experimentation or other kind of research or study

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v: Individuals engaged in the research will have no part in determining the viability of a neonate

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    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

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

v: p9.1.7.31.7

v: For non-viable neonates, the vital functions of the neonate will not be artificially maintained and that the research will not terminate the heartbeat or respiration of the neonate

v: choice

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

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

v: p9.1.7.31.8

v: For neonates of uncertain viability, the research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective

v: choice

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: drop-down
      display:
        v: Drop down
    text:
      v: Drop down
link id:
  v: p9.1.7.4
text:
  v: Can or will participants who are not yet adults (neonates, children, teenagers) be enrolled?
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: p9.1.7.5
text:
  v: Enrollment of participants who are not yet adults (neonates, children, teenagers)
type:
  v: group
enable when:
  question:
    v: p9.1.7.4
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: p9.1.7.5.1
  text:
    v: I will follow the SOP: Legally Authorized Representatives, Children, and Guardians (HRP-013) to determine whether a prospective participant has or has not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted. (e.g., individuals under the age of 18 years).
  type:
    v: choice
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
  item:
    link id:
      v: p9.1.7.5.1.1
    text:
      v: If this SOP will not be followed, describe how this (attainment of legal age for consent or not) will be determined
    type:
      v: text
    required:
      v: false
item:
  link id:
    v: p9.1.7.5.2
  text:
    v: Describe how permission to participate in the study will be obtained from the parents or legal guardians
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p9.1.7.5.3
  text:
    v: Assent process of children
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: p9.1.7.5.3.1
    text:
      v: Describe waiting period between informing the prospective participant and obtaining the assent
    type:
      v: text
    required:
      v: false
    repeats:
      v: false
    read only:
      v: false
  item:
    link id:
      v: p9.1.7.5.3.2
    text:
      v: Describe any process to ensure ongoing assent
    type:
      v: text
    required:
      v: false
    repeats:
      v: false
    read only:
      v: false
  item:
    link id:
      v: p9.1.7.5.3.3
    text:
      v: Describe Research team members involved in the assent process
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p9.1.7.5.3.4
    text:
      v: Describe how long children will have to consider study participation
    type:
      v: text
    required:
      v: false
    repeats:
      v: false
    read only:
      v: false
  item:
    link id:
      v: p9.1.7.5.3.5
    text:
      v: Describe steps that will be taken to minimize the possibility of coercion or undue influence
    type:
      v: text
    required:
      v: false
    repeats:
      v: false
    read only:
      v: false
  item:
    link id:
      v: p9.1.7.5.3.6
    text:
      v: Describe steps that will be taken to ensure the participants's understanding
    type:
      v: text
    required:
      v: false
    repeats:
      v: false
    read only:
      v: false
  item:
    link id:
      v: p9.1.7.5.3.7
    text:
      v: If assent will not be obtained from children, specify why
    type:
      v: text
    required:
      v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p9.1.7.5.3.8
    text:
      v: Will children reach 18 years of age while in the study?
    type:
      v: choice
    required:
      v: false
    answer option:
      value: Coding
    answer option:
      value: Coding
  item:
    link id:
      v: p9.1.7.5.3.9
    text:
      v: Children reaching 18 years of age while in the study
    type:
      v: group
    enable when:
      question:
        v: p9.1.7.5.3.8
      operator:
        v: =
      answer: Coding
    required:
      v: false
    item:
      link id:
        v: p9.1.7.5.3.9.1
      text:
        v: Describe the plan to obtain written informed consent from the participant at age 18 years
      type:
        v: text
      required:
        v: false

v: drop-down

v: Drop down

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: Y

link id:
  v: p9.1.7.5.3.9.2
text:
  v: Describe who will be responsible for managing the plan
type:
  v: text
required:
  v: false

link id:
  v: p9.1.7.5.3.9.3
text:
  v: Describe where the consent discussion will take place
type:
  v: text
required:
  v: false
repeats:
  v: false
read only:
  v: false

link id:
  v: p9.1.7.5.3.9.4
text:
  v: Describe what will happen if the participant cannot be located to provide consent at age 18 years
type:
  v: text
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: p9.1.7.6
text:
  v: Can or will minors who are: i)married, widowed, divorced; or ii)Parent of a child; or iii)a member of any of the armed forces; or iv)pregnant or believes herself to be pregnant; or v)living separate and apart from his/her parent or legal guardian, and is managing his/her own financial affairs be approached for study participation for either themselves or their child?
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: p9.1.7.7
text:
  v: Enrollment of minors who are: i)married, widowed, divorced; or ii)Parent of a child; or iii)a member of any of the armed forces; or iv)pregnant or believes herself to be pregnant; or v)living separate and apart from his/her parent or legal guardian, and is managing his/her own financial affairs be approached for study participation for either themselves or their child.
type:
  v: group
enable when:
  question:
    v: p9.1.7.6
  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
item:
  link id:
    v: p9.1.7.7.1
  text:
    v: Describe how will it be determined that this population has the capacity to consent for this study. Please note that the circumstance of parenthood, pregnancy, etc. may not mean that the person has the same capacity of an adult who can understand the risks, benefits, and alternatives for indicated care. Thus, sound and sensitive clinical judgment that is attentive to both the minorrights and the minoractual competence and needs must be considered, and is to include a determination as to whether involvement of family or other adults familiar to the minor is necessary and appropriate
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p9.1.7.7.2
  text:
    v: Describe how informed consent will be executed with this population in a way that allows for independent and thoughtful decision-making
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p9.1.7.7.3
  text:
    v: Describe any additional steps or procedures that will be used when performing informed consent with this population
  type:
    v: text
  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: p9.1.7.8
text:
  v: Can or will cognitively impaired adults (adults with impaired-decision making capacity) or adults who may lose the capacity to consent be enrolled?
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: p9.1.7.9
text:
  v: Enrollment of cognitively impaired adults (adults with impaired-decision making capacity) or adults who may lose the capacity to consent
type:
  v: group
enable when:
  question:
    v: p9.1.7.8
  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
item:
  link id:
    v: p9.1.7.9.1
  text:
    v: Describe whether the research holds out a prospect of direct benefit to the individual participant that is unavailable outside the research context
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p9.1.7.9.2
  text:
    v: Describe why the objectives of the study cannot be met by enrolling participants who are able to give consent
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p9.1.7.9.4
  text:
    v: Describe the process to determine whether or not the individual is capable of consent
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p9.1.7.9.5
  text:
    v: Describe who will determine if the participant is able to provide informed consent
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p9.1.7.9.6
  text:
    v: Describe how it will be determined whether the participant is able to provide informed consent
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p9.1.7.9.7
  text:
    v: Describe when and how often (even after obtaining informed consent) it will be determined whether the participant is able to provide informed consent
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p9.1.7.9.8
  text:
    v: List the individuals from whom permission will be obtained if the participant cannot provide informed consent. Prioritize the list (e.g., durable power of attorney for health care, court appointed guardian for health care decisions, spouse, and adult child.)
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p9.1.7.9.9
  text:
    v: If it is possible that participants may regain capacity to provide informed consent during the study, describe how frequently this will be assessed and state that participants will be consented to the study in the event that they regain capacity to provide informed consent
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p9.1.7.9.10
  text:
    v: Process for assent of participants
  type:
    v: group
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
  item:
    link id:
      v: p9.1.7.9.10.1
    text:
      v: Describe whether assent will be required of all, some, or none of the participants. If some, specify which participants will be required to assent and which will not
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p9.1.7.9.10.2
    text:
      v: If assent will not be obtained from some or all participants, an explanation of why not
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p9.1.7.9.10.3
    text:
      v: Describe whether assent of the participants will be documented and the process to document assent. The IRB allows the person obtaining assent to document assent on the consent document and does not routinely require assent documents and does not routinely require participants to sign assent documents
    type:
      v: text
    required:
      v: false
item:
  link id:
    v: p9.1.7.9.11
  text:
    v: Provide a description of how the patient will be informed of the potential risks and benefits of the study and any procedures associated with its use
  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: p9.1.7.9.12
  text:
    v: Participants will be withdrawn if they appear to be unduly distressed at any time during the study.
  type:
    v: choice
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No

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: p9.1.7.10
text:
  v: Can or will prisoners be enrolled?
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: p9.1.7.11
text:
  v: Enrollment of prisoners
type:
  v: group
enable when:
  question:
    v: p9.1.7.10
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
required:
  v: false
item:
  link id:
    v: p9.1.7.11.1
  text:
    v: Describe any possible advantages accruing to the Prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p9.1.7.11.2
  text:
    v: Describe whether the risks involved in the research are commensurate with risks that would be accepted by non-Prisoner volunteers
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p9.1.7.11.3
  text:
    v: Describe procedures for the selection of participants within the prison which are fair to all Prisoners and immune from arbitrary intervention by prison authorities or Prisoners. Unless the Principal Investigator provides to the Board justification in writing for following some other procedures, control participants must be selected randomly from the group of available Prisoners who meet the characteristics needed for that particular research project
  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: p9.1.7.11.4
  text:
    v: Parole boards will not take into account a Prisoner participation in the research in making decisions regarding parole, and each Prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole.
  type:
    v: choice
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
item:
  link id:
    v: p9.1.7.11.6
  text:
    v: If follow-up examination or care of participants after the end of their participation is required, describe the provision for such examination or care, taking into account the varying lengths of individual Prisoners sentences, and for informing participants of this fact
  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: p9.1.7.12
text:
  v: Can or will students and/or employees be enrolled in 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

link id:
  v: p9.1.7.13
text:
  v: Enrollment of students and/or employees
type:
  v: group
enable when:
  question:
    v: p9.1.7.12
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
required:
  v: false
item:
  link id:
    v: p9.1.7.13.1
  text:
    v: Describe the justification for specifically targeting recruitment efforts to enroll students and/or employees
  type:
    v: text
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
item:
  link id:
    v: p9.1.7.13.2
  text:
    v: Describe how potential coercion will be eliminated
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p9.1.7.13.3
  text:
    v: Describe the recruitment methods to be applied specifically to students and/or employees. If the same recruitment methods previously described in the protocol will be used, then state that
  type:
    v: text
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
item:
  link id:
    v: p9.1.7.13.4
  text:
    v: Describe additional safeguards included to protect the rights and welfare of students and employees
  type:
    v: text
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
item:
  link id:
    v: p9.1.7.13.5
  text:
    v: Describe protections to ensure that a participant's decision about participation and/or early withdrawal from the study will not affect his/her status as a student or employee
  type:
    v: text
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: p9.1.7.13.6
  text:
    v: Submitted a letter from the appropriate institutional official (e.g., Department Chair, Dean, Vice-President) who oversees the students and/or employees attesting to the fact that the employeeor studentparticipation in the research is acceptable and that coercion has been minimized.
  type:
    v: choice
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No

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: p9.1.7.14
text:
  v: Can or will wards of the state and/or children at risk of becoming wards of the state be enrolled (this includes foster children or any child that is in state custody)?
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: p9.1.7.15
text:
  v: Enrollment of wards of the state and/or children at risk of becoming wards of the state be enrolled (this includes foster children or any child that is in state custody).
type:
  v: group
enable when:
  question:
    v: p9.1.7.14
  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
item:
  link id:
    v: p9.1.7.15.1
  text:
    v: Describe the justification for recruiting and enrolling this population
  type:
    v: text
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
item:
  link id:
    v: p9.1.7.15.2
  text:
    v: Describe any additional details about the recruitment methods to be used. If the same recruitment methods previously described in the protocol will be used, then state that
  type:
    v: text
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
item:
  link id:
    v: p9.1.7.15.3
  text:
    v: Describe any additional details about the informed consent process to be used. If the same informed consent process for enrolling minors previously described in the protocol will be used, then state that
  type:
    v: text
  required:
    v: false
  repeats:
    v: false
  read only:
    v: false
item:
  link id:
    v: p9.1.7.15.4
  text:
    v: Describe how it will be ensured that the appropriate person(s) grants permission for each ward to participate in the research
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p9.1.7.15.5
  text:
    v: Describe how the research team will know if there has been a change in guardianship status during the course of the research and how permission will be obtained from the new guardian
  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: p9.1.7.15.6
  text:
    v: Is the study is greater than minimal risk?
  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: p9.1.7.15.7
  text:
    v: Greater than minimal risk study
  type:
    v: group
  enable when:
    question:
      v: p9.1.7.15.6
    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
  item:
    link id:
      v: p9.1.7.15.7.1
    text:
      v: Describe whether the research is related to their status as wards OR if the research is conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as participants are not wards
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p9.1.7.15.7.2
    text:
      v: Describe how an advocate will be appointed for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p9.1.7.15.7.3
    text:
      v: Describe the background and experience of the advocate to act in the best interests of the child for the duration of the childparticipation in the research
    type:
      v: text
    required:
      v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p9.1.7.15.7.4
    text:
      v: The advocate will not be associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.
    type:
      v: choice
    required:
      v: false
    repeats:
      v: false
    read only:
      v: false
    answer option:
      value: Coding
    answer option:
      value: Coding

v: drop-down

v: Drop down

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

link id:
  v: p9.2
text:
  v: Strategies for Recruitment and Retention
  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: p9.2.1
  text:
    v: Recruitment Methods
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: p9.2.1.1
    text:
      v: Describe when, where, and how potential participants will be recruited
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p9.2.1.1_help
      text:
        v: Provide a broad overview of the recruitment activities. Specific media, content, duration and scripts will be gathered on the Recruitment Materials Questionnaire.
      type:
        v: display
  item:
    link id:
      v: p9.2.1.2
    text:
      v: When participants respond to recruitment material, describe the information that will be collected from participants (e.g. name, telephone number, etc.).
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p9.2.1.3
    text:
      v: Describe source of participants (for example, patient population, local community, etc.)
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p9.2.1.4
    text:
      v: Describe methods that will be used to identify potential participants
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p9.2.1.5
    text:
      v: Describe how the recruitment methods described will be effective in attracting the targeted participant population
    type:
      v: text
    required:
      v: false

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: p9.3
text:
  v: Duration of Study Participation (If there are sub-studies, include duration of participation in each sub-study.)
type:
  v: text
required:
  v: false

link id:
  v: p10
text:
  v: Study Intervention
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color: #274e90; font-size: 150%
type:
  v: group
enable when:
  question:
    v: p1.1
  operator:
    v: =
  answer: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: INT
required:
  v: false
item:
  link id:
    v: p10.1
  text:
    v: Study Agent
    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
  read only:
    v: false
  item:
    link id:
      v: p10.1.1
    text:
      v: Study Agent and Control Description
    type:
      v: text
    required:
      v: false
    repeats:
      v: false
    read only:
      v: false
  item:
    link id:
      v: p10.1.2
    text:
      v: Receipts/Acquisition
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p10.1.2_help
      text:
        v: State how the study intervention and control product will be provided to the investigator, including who will be supplying the investigational product and any other protocol dictated medications/devices. If investigational product(s) will be purchased through commercial sources, state this.
      type:
        v: display
  item:
    link id:
      v: p10.1.3
    text:
      v: Study Agent Accountability/ Return or Destruction of Investigational Product
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p10.1.3_help
      text:
        v: Describe plans about how and by whom the study intervention will be distributed, including participation of a drug repository or pharmacy, and plans for disposal of expired or return of unused product.
      type:
        v: display
  item:
    link id:
      v: p10.1.4
    text:
      v: Formulation and appearance of Control Product
    type:
      v: text
    required:
      v: false
    repeats:
      v: false
    read only:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p10.1.4_help
      text:
        v: Describe the formulation and appearance the study intervention. This section should include the name of the manufacturer of the control product.
      type:
        v: display
  item:
    link id:
      v: p10.1.5
    text:
      v: Formulation and appearance of Test Product
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p10.1.5_help
      text:
        v: Describe the formulation and appearance the study intervention. This section should include the name of the manufacturer of the control product.
      type:
        v: display
  item:
    link id:
      v: p10.1.6
    text:
      v: Packaging and Labeling
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p10.1.6_help
      text:
        v: Describe the packaging and labeling of the study intervention and control product, as supplied. Information in this section can usually be obtained from the IB or the package insert, or device labeling.
      type:
        v: display
  item:
    link id:
      v: p10.1.7
    text:
      v: Product Storage and Stability
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p10.1.7_help
      text:
        v: Describe storage and stability requirements (e.g., protection from light, temperature, humidity) for the study intervention and control product. For studies in which multi-dose vials are utilized, provide additional information regarding stability and expiration time after initial use (e.g., the seal is broken).
      type:
        v: display
  item:
    link id:
      v: p10.1.8
    text:
      v: Preparation
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p10.1.8_help
      text:
        v: Description of the preparation of the study intervention and control product, including any preparation required by study staff and/or study participants. Include thawing, diluting, mixing, and reconstitution/preparation instructions, as appropriate. For devices, include any relevant assembly or use instructions.
      type:
        v: display
  item:
    link id:
      v: p10.1.9
    text:
      v: Administration and/or Dosing
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p10.1.9_help
      text:
        v: Describe the procedures for selecting each participant's dose of study intervention and control product. For drugs, that includes the timing of dosing (e.g., time of day, interval), the duration (e.g., the length of time study participants will be administered the study intervention), the planned route of administration (e.g., oral, nasal, intramuscular), and the relation of dosing to meals.
      type:
        v: display

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

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

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

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

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

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

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

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

link id:
  v: p10.1.10
text:
  v: Route of Administration
type:
  v: text
required:
  v: false

link id:
  v: p10.1.11
text:
  v: Starting Dose and Dose Escalation Schedule
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: p10.1.11_help
  text:
    v: State the starting dose and schedule of the study intervention and control product, including the maximum and minimum duration for those participants who continue in the study. For example, in some oncology trials for participants with no available therapeutic alternatives, intervention continues even after disease progression. In this instance, consider alternative designs that enable participants to rollover to a continued treatment arm and include appropriate instructions to guide this implementation.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p10.1.12
text:
  v: Dose Adjustments/Modifications/Delays
type:
  v: text
required:
  v: false

link id:
  v: p10.1.13
text:
  v: Duration of Therapy
type:
  v: text
required:
  v: false

link id:
  v: p10.1.14
text:
  v: Tracking Dose
type:
  v: text
required:
  v: false

link id:
  v: p10.1.15
text:
  v: Device Specific Considerations
type:
  v: text
required:
  v: false

link id:
  v: p10.1.16
text:
  v: Administration Instructions
type:
  v: text
required:
  v: false

link id:
  v: p10.1.17
text:
  v: Dispensing [authority, requirements]
type:
  v: text
required:
  v: false

link id:
  v: p10.1.18
text:
  v: Supply of Study Drug at the Site
type:
  v: text
required:
  v: false

link id:
  v: p10.2
text:
  v: Study Behavioral or Social Intervention(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: p1.2
  operator:
    v: =
  answer: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: SBE
required:
  v: false
item:
  link id:
    v: p10.2.1
  text:
    v: Administration of Intervention
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p10.2.2
  text:
    v: Procedures for Training Interventionalists and Monitoring Intervention Fidelity
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p10.2.3
  text:
    v: Assessment of participant Compliance with Study Intervention
  type:
    v: text
  required:
    v: false

link id:
  v: p10.3
text:
  v: Study Procedural Intervention(s) Description
  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: p10.3.1
  text:
    v: Administration of Procedural Intervention
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p10.3.2
  text:
    v: Procedures for Training of Clinicians on Procedural Intervention
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p10.3.3
  text:
    v: Assessment of Clinician and/or Participant Compliance with Study Procedural Intervention
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p10.3.3_help
    text:
      v: Define how adherence to the protocol (e.g., administration of study intervention, use of device,) will be assessed, and verified (if applicable, e.g., plasma assays, electronic monitoring devices, daily diaries). Include a discussion of what documents are mandatory to complete (e.g., participant drug log) and what source documents/records will be used to calculate study intervention compliance.
    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: p10.4
text:
  v: Participant Compliance and Monitoring
type:
  v: text
required:
  v: false

link id:
  v: p10.5
text:
  v: Study Intervention/Experimental Manipulation Adherence
type:
  v: text
required:
  v: false

link id:
  v: p11
text:
  v: Study Intervention Discontinuation and Participant Discontinuation/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:
  link id:
    v: p11.1
  text:
    v: Discontinuation of Study Intervention
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p11.1_help
    text:
      v: Participants may withdraw voluntarily from the study or the PI may discontinue a participant from the study. This section should state which adverse events would result in discontinuation of study intervention or participant discontinuation/withdrawal. In addition, participants may discontinue the study intervention, but remain in the study for follow-up, especially for safety and efficacy study endpoints (if applicable). A Case Report Form (CRF) should capture the date and the specific underlying reason for discontinuation of study intervention or participant discontinuation/withdrawal.
    type:
      v: display
item:
  link id:
    v: p11.2
  text:
    v: Participant withdrawal and Termination
    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: p11.2.1
    text:
      v: Reasons for Withdrawal or Termination
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p11.2.2
    text:
      v: Handling of Participant Withdrawal or Termination
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p11.2.3
    text:
      v: Replacement of participants
    type:
      v: text
    required:
      v: false
item:
  link id:
    v: p11.3
  text:
    v: Lost to Follow-Up
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p11.3_help
    text:
      v: The protocol should describe the nature and duration of study follow-up. Participants are considered lost to follow-up when they stop reporting to scheduled study visits and cannot be reached to complete all protocol-required study procedures. Describe the plans to minimize loss to follow-up and missing data.
    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: p12
text:
  v: Study 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: p12.1
  text:
    v: Study Procedures/Evaluations
    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: p12.1.1
    text:
      v: Study Specific Procedures
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p12.1.2
    text:
      v: Standard of Care Study Procedures
    type:
      v: text
    required:
      v: false
item:
  link id:
    v: p12.2
  text:
    v: Laboratory Procedures/Evaluations
    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: p12.2.1
    text:
      v: Clinical Laboratory Evaluations
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p12.2.2
    text:
      v: Research Laboratory Evaluations
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p12.2.3
    text:
      v: Other Assays or Procedures
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p12.2.4
    text:
      v: Specimen Preparation, Handling, and Storage
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p12.2.5
    text:
      v: Specimen Shipment
    type:
      v: text
    required:
      v: false
item:
  link id:
    v: p12.3
  text:
    v: Data Collection and Follow Up for Withdrawn participants
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p12.4
  text:
    v: Justification for Sensitive Procedures (e.g., use of placebo, medication withdrawal, provocative testing, and deception).
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p12.5
  text:
    v: Precautionary Medications, Treatments, and Procedures
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p12.6
  text:
    v: Prohibited Medications, Treatments, and Procedures
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p12.7
  text:
    v: Prophylactic Medications, Treatments, and Procedures
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p12.8
  text:
    v: Rescue Medications, Treatments, and Procedures
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p12.8_help
    text:
      v: List all medications, treatments, and/or procedures that may be provided during the study for "rescue therapy" and relevant instructions about administration of rescue medications.
    type:
      v: display
item:
  link id:
    v: p12.9
  text:
    v: Participant Access to Study Agent at Study Closure
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p12.10
  text:
    v: Concomitant Medications, Treatments , and Procedures
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p12.10_help
    text:
      v: This section should be consistent with the medication restrictions in the inclusion/exclusion criteria previously listed. Describe the data that will be recorded related to permitted concomitant medications, supplements, complementary and alternative therapies, treatments, and/or procedures. Include details about when the information will be collected (e.g., screening, all study visits). Describe how allowed concomitant therapy might affect the outcome (e.g., drug-drug interaction, direct effects on the study endpoints) and how the independent effects of concomitant and study interventions could be ascertained.
    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: p13
text:
  v: Schedule of Study Procedures
  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:
  link id:
    v: p13.1
  text:
    v: Screening
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p13.2
  text:
    v: Enrollment/Visit 1/Baseline Visit
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p13.3
  text:
    v: Intermediate Visits
  type:
    v: text
  required:
    v: false
  repeats:
    v: true
item:
  link id:
    v: p13.4
  text:
    v: Final Study Visit
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p13.5
  text:
    v: Withdrawal/Early Termination Visit
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p13.6
  text:
    v: Unscheduled Visit
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p13.7
  text:
    v: Follow Up Phase of the Study
    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:
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    text:
      v: Visit
    type:
      v: text
    required:
      v: false
    repeats:
      v: true
  item:
    link id:
      v: p13.7.2
    text:
      v: End of Study Visit
    type:
      v: text
    required:
      v: false
item:
  link id:
    v: p13.15
  text:
    v: Schedule of Study Procedures Attachments
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style
      value:
        v: color:#2a623d; font-size: 125%
  type:
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  required:
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  repeats:
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      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p13.15_help
    text:
      v: Attachments regarding the Schedule of Study Procedures can be attached here.
    type:
      v: display
  item:
    link id:
      v: p13.15.1
    text:
      v: Describe the file that is being attached (optional)
    type:
      v: string
    required:
      v: false
  item:
    link id:
      v: p13.15.2
    text:
      v: Attachment
    type:
      v: attachment
    required:
      v: false

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

v: Help-Button

link id:
  v: p14
text:
  v: Assessment of Safety
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color: #274e90; font-size: 150%
type:
  v: group
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: p14_help
  text:
    v: Assessments related to safety and the aspects of the study which are proposed to ensure the safety of trial participants, the risks of the study intervention, and other study procedures and the characteristics of the study population (e.g., vulnerable populations such as children).
  type:
    v: display
item:
  link id:
    v: p14.1
  text:
    v: Specification of Safety Parameters
    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: p14.1.1
    text:
      v: Definition of Adverse Events(AE)
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p14.1.1_help
      text:
        v: Provide the definition of an AE being used for the clinical trial.
      type:
        v: display
  item:
    link id:
      v: p14.1.2
    text:
      v: Definition of Serious Adverse Events (SAE)
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p14.1.2_help
      text:
        v: Provide the definition of an SAE being used for the clinical trial.
      type:
        v: display
  item:
    link id:
      v: p14.1.3
    text:
      v: Definition of Unanticipated Problems
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p14.1.3_help
      text:
        v: This includes any incident or outcome that is not expected in terms of nature, frequency, or severity related to the research procedures and participants.
      type:
        v: display
item:
  link id:
    v: p14.2
  text:
    v: Classification of an Adverse Event
    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: p14.2.1
    text:
      v: Severity of an Event
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p14.2.1_help
      text:
        v: All AEs are assessed by the study clinician using a protocol defined grading system. Describe the method of grading an AE for severity. For example, many toxicity tables are available for use and are adaptable to various study designs.
      type:
        v: display
  item:
    link id:
      v: p14.2.2
    text:
      v: Relationship to Study Intervention/Experimental Manipulation
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p14.2.2_help
      text:
        v: Description of the method of determining the relationship of an AE to a study intervention. If there is any doubt as to whether a clinical observation is an AE, the event should be reported. Some protocols may use a binary assessment (related/not related); others may have a scale of relatedness.
      type:
        v: display
  item:
    link id:
      v: p14.2.3
    text:
      v: Expectedness
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p14.2.3_help
      text:
        v: Description of an adverse event, the nature or severity is not in Investigator Brochure or has been observed, or, if an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere
      type:
        v: display
item:
  link id:
    v: p14.3
  text:
    v: Time Period and Frequencey for Event Assessment and Follow-Up
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p14.4
  text:
    v: Reporting Procedures
    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: p14.4.1
    text:
      v: Notifying the IRB
    type:
      v: group
    required:
      v: false
    item:
      link id:
        v: p14.4.1.1
      text:
        v: Adverse Event Reporting
      type:
        v: text
      required:
        v: false
    item:
      link id:
        v: p14.4.1.2

v: help

v: Help-Button

CodeableConcept
coding:
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  v: Help-Button

CodeableConcept
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CodeableConcept
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CodeableConcept
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CodeableConcept
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  v: Help-Button

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: help
    display:
      v: Help-Button
  text:
    v: Help-Button

v: p14.4.1.1_help

v: Description of the AE reporting procedures, including timeframes

v: display

v: Serious Adverse Event Reporting

v: text

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: help
      display:
        v: Help-Button
    text:
      v: Help-Button
link id:
  v: p14.4.1.2_help
text:
  v: Description of the SAE reporting procedures, including timeframes
type:
  v: display

link id:
  v: p14.4.1.3
text:
  v: Unanticipated Problem Reporting
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: p14.4.1.3_help
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    v: This section addresses responsibilities of investigators for reporting of UPs. Describe the UP reporting procedures, including timeframes. Further details should be included in a MOP or SOP including a description and a flow chart of when events are reported to various oversight (e.g., DSMB, safety monitoring committee, independent safety monitor) and regulatory s, and what study staff are responsible for completing and signing off on the UP report forms. Institutions engaged in human subjects research conducted or supported by Department of Health and Human Services (DHHS) must have written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and any supporting department or agency head of any unanticipated problem involving risks to subjects or others (45 CFR 46.103(b)(5)). Furthermore, for research covered by an assurance approved for federal wide use by OHRP, DHHS regulations at 45 CFR 46.103(a) require that institutions promptly report any unanticipated problems to OHRP. Refer to the Reportable Events guidance in IRBear for further details.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p14.4.1.4
text:
  v: Reporting of Pregnancy
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: p14.4.1.4_help
  text:
    v: State the study's pregnancy-related policy and procedure. Include appropriate mechanisms for reporting to the DCC or NIH, the IND or IDE sponsor, study leadership, IRB, and regulatory agencies. Provide appropriate modifications to study procedures (e.g., discontinuation of study intervention, while continuing safety follow-up, requesting permission to follow pregnant women to pregnancy outcome).
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p14.4.2
text:
  v: Notifyiing the Study Sponsor
type:
  v: text
required:
  v: false

link id:
  v: p14.4.3
text:
  v: Notifying the FDA
type:
  v: text
required:
  v: false

link id:
  v: p14.4.4
text:
  v: Notifying Participating Investigators
type:
  v: text
required:
  v: false

link id:
  v: p14.4.5
text:
  v: Reporting Events to Participants
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: p14.4.5_help
  text:
    v: Describe how participants will be informed about AEs and SAEs, and study-related results on an individual or aggregate level. In addition, describe plans for detecting and managing incidental findings associated with study procedures
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p14.4.6
text:
  v: Events of Special Interest
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: p14.4.6_help
  text:
    v: Describe any other events that merit reporting to the sponsor, study leadership, IRB, and regulatory agencies. For example, in oncology trials, secondary malignancies are often captured.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p14.5
text:
  v: Follow Up Report
type:
  v: text
required:
  v: false

link id:
  v: p14.6
text:
  v: Study Halting/Stopping Rules
type:
  v: text
required:
  v: false

link id:
  v: p15
text:
  v: Statistical Considerations
  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: p15.1
  text:
    v: Statistical and Analytical Plans(SAP)
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p15.2
  text:
    v: Statistical Hypotheses
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p15.2_help
    text:
      v: State the formal and testable null and alternative hypotheses for primary and key secondary endpoints, specifying the type of comparison (e.g., superiority, equivalence or non-inferiority, dose response) and time period for which each endpoint will be analyzed.
    type:
      v: display
item:
  link id:
    v: p15.3
  text:
    v: Analysis Datasets
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p15.3_help
    text:
      v: Clearly identify and describe the analysis datasets (e.g., which participants will be included in each).
    type:
      v: display
item:
  link id:
    v: p15.4
  text:
    v: Populations for Analysis
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p15.5
  text:
    v: Sample Size Determination
  type:
    v: text
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: p15.5_help
    text:
      v: Include number of participants to recruit, screen, and enroll to have adequate power to test the key hypotheses for the study. Provide all information needed to validate and judge the feasibility of enrolling and following the necessary number of participants. Discuss whether the sample size provides sufficient power for addressing secondary endpoints or exploratory analyses (e.g., sub analyses or moderator analyses involving an interaction term)
    type:
      v: display
item:
  link id:
    v: p15.6
  text:
    v: Description of Statistical Methods
    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: p15.6.1
    text:
      v: General Approach
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p15.6.2
    text:
      v: Analysis of Primary Efficacy Endpoints(s)
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p15.6.3
    text:
      v: Analysis of Secondary Endpoint(s)
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p15.6.4
    text:
      v: Safety Analyses
    type:
      v: text
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: p15.6.4_help
      text:
        v: Describe how safety endpoints will be analyzed (e.g., as summary statistics during treatment and/or as change scores from baselines such as shift tables). The information included here should be consistent with the information contained within Assessment of Safety section.
      type:
        v: display
  item:
    link id:
      v: p15.6.5
    text:
      v: Adherence and Retention Analyses
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p15.6.6
    text:
      v: Baseline Descriptive Statistics
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p15.6.7
    text:
      v: Planned Interim Analyses
    type:
      v: group
    required:
      v: false
    item:
      link id:
        v: p15.6.7.1
      text:
        v: Safety Review
      type:
        v: text
      required:
        v: false
    item:
      link id:
        v: p15.6.7.2
      text:
        v: Efficacy Review
      type:
        v: text
      required:
        v: false
  item:
    link id:
      v: p15.6.8
    text:
      v: Additional Sub-Group Analyses
    type:
      v: text

system:
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  v: help
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v: Help-Button

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

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  code:
    v: help
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text:
  v: Help-Button

v: false

link id:
  v: p15.6.9
text:
  v: Multiple Comparison/Multiplicity
type:
  v: text
required:
  v: false

link id:
  v: p15.6.10
text:
  v: Tabulation of Individual Response Data
type:
  v: text
required:
  v: false

link id:
  v: p15.6.11
text:
  v: Exploratory Analyses
type:
  v: text
required:
  v: false

link id:
  v: p15.6.12
text:
  v: Pharmacokinetic Analysis (if applicable)
type:
  v: text
required:
  v: false
repeats:
  v: false
read only:
  v: false

link id:
  v: p15.7
text:
  v: Sample Size
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  v: text
required:
  v: false
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        v: Help-Button
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    v: p15.7_help
  text:
    v: Include number of participants to recruit, screen, and enroll to have adequate power to test the key hypotheses for the study. Provide all information needed to validate your calculations and judge the feasibility of enrolling and following the necessary number of participants.Further, present calculations from a suitable range of assumptions to gauge the robustness of the proposed sample size. Discuss whether the sample size provides sufficient power for addressing secondary endpoints or exploratory analyses.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: p15.8
text:
  v: Measures to Minimize Bias
  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: p15.8.1
  text:
    v: Enrollment/Randomization/Masking Procedures
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p15.8.2
  text:
    v: Evaluation of Success of Blinding
  type:
    v: text
  required:
    v: false
item:
  link id:
    v: p15.8.3
  text:
    v: Breaking the Study Blind/Participant Code
  type:
    v: text
  required:
    v: false

link id:
  v: p16
text:
  v: Supporting Documentation and Operational Considerations
  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: p16.1
  text:
    v: Regulatory, Ethical and Study Oversight Considerations
    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: p16.1.1
    text:
      v: Protocol Amendments
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p16.1.2
    text:
      v: Ethical Standard
    type:
      v: text
    required:
      v: false
  item:
    link id:
      v: p16.1.3
    text:
      v: Institutional Review Board