sirb-initiate-study-questionnaire-populate
type: Questionnaire
node role: treeRoot
id:
  v: sirb-initiate-study-questionnaire-populate
meta:
  tag:
    system:
      v: http://lhncbc.github.io/lforms/
    code:
      v: lformsVersion: 29.0.3
text:
  status:
    v: generated
  div: Structure LinkId Text Cardinality Type Flags Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> SIRBInitiateAStudyQuestionnaire Initiate a Study Questionnaire Questionnaire http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire-populate#1.0.0 in1 Research Study Details 0..1 group in1.1 Study Title 1..1 string in1.1_help 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) 0..1 display in1.2 Study Title (Short) 1..1 string in1.2_help A short study title written in language intended for the lay public. 0..1 display in1.3 IRB Protocol Number 1..1 string in1.3_help The Protocol Number assigned by the sIRB 0..1 display in1.4 Study Type 1..1 choice Options: 2 options in1.4_help Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional) 0..1 display DIVIDER1 null 0..1 display in5 Other Organization(s) Involved 0..* group in5.1 Relationship Type 1..1 choice Options: 2 options in5.1_help Select the organization's type of involvement in the study 0..1 display in5.2 Organization Name 1..1 string in5.2_help e.g. NIH or company name 0..1 display in5.3 Phone 0..1 string in5.3_help 10 digit phone number, including area code 0..1 display in5.4 Sponsor or Funding Source Protocol Number, if applicable 0..1 string in5.4_help Unique Protocol Identification Number used by the sponsor, if applicable 0..1 display in5.5 Other Organization Name, Relationship Type, Phone and Protocol Number (read-only) 0..1 string Expressions: Calculated Value: %combinedOtherOrgUniqueOneRepetition in5.6 Protocol Number with Organization Name (read-only) 0..1 string Expressions: Calculated Value: %otherOrgProto…
url:
  v: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire-populate
version:
  v: 1.0.0
name:
  v: SIRBInitiateAStudyQuestionnaire
title:
  v: Initiate a Study 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
description:
  v: Initiate a Study Questionnaire
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:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Group Table
  link id:
    v: in1
  text:
    v: Research Study Details
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style
      value:
        v: color:#274e90; font-size: 160%
  type:
    v: group
  required:
    v: false
  repeats:
    v: false
  item:
    link id:
      v: in1.1
    text:
      v: Study Title
    type:
      v: string
    required:
      v: true
    item:
      extension:
        value: CodeableConcept
      link id:
        v: in1.1_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
  item:
    link id:
      v: in1.2
    text:
      v: Study Title (Short)
    type:
      v: string
    required:
      v: true
    item:
      extension:
        value: CodeableConcept
      link id:
        v: in1.2_help
      text:
        v: A short study title written in language intended for the lay public.
      type:
        v: display
  item:
    link id:
      v: in1.3
    text:
      v: IRB Protocol Number
    type:
      v: string
    required:
      v: true
    item:
      extension:
        value: CodeableConcept
      link id:
        v: in1.3_help
      text:
        v: The Protocol Number assigned by the sIRB
      type:
        v: display
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in1.4
    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: in1.4_help
      text:
        v: Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)
      type:
        v: display
item:
  link id:
    v: DIVIDER1
  type:
    v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Group Table
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/variable
    value: Expression
      description:
        v: Other Org Relationship Type
      name:
        v: otherOrgRelTypeOneRepetition
      language:
        v: text/fhirpath
      expression:
        v: iif(item.where(linkId = 'in5.1').answer.valueCoding.display.exists(), item.where(linkId = 'in5.1').answer.valueCoding.display, ' ')
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/variable
    value: Expression
      description:
        v: Other Org Name
      name:
        v: otherOrgNameOneRepetition
      language:
        v: text/fhirpath
      expression:
        v: iif(item.where(linkId = 'in5.2').answer.valueString.exists(), item.where(linkId = 'in5.2').answer.valueString, ' ')
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/variable
    value: Expression
      description:
        v: Other Org Phone
      name:
        v: otherOrgPhoneOneRepetition
      language:
        v: text/fhirpath
      expression:
        v: iif(item.where(linkId = 'in5.3').answer.valueString.exists(), item.where(linkId = 'in5.3').answer.valueString, ' ')
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/variable
    value: Expression

v: gtable

v: Group Table

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

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

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: 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

v: gtable

v: Group Table

Expression
description:
  v: Other Org Protocol
name:
  v: otherOrgProtocolOneRepetition
language:
  v: text/fhirpath
expression:
  v: iif(item.where(linkId = 'in5.4').answer.valueString.exists(), item.where(linkId = 'in5.4').answer.valueString, ' ')

url:
  v: http://hl7.org/fhir/StructureDefinition/variable
value: Expression
  description:
    v: combination of Other Org fields to make unique identifier
  name:
    v: combinedOtherOrgUniqueOneRepetition
  language:
    v: text/fhirpath
  expression:
    v: %otherOrgNameOneRepetition + ' | ' + %otherOrgPhoneOneRepetition + ' | ' + %otherOrgProtocolOneRepetition + ' | ' + %otherOrgRelTypeOneRepetition

url:
  v: http://hl7.org/fhir/StructureDefinition/variable
value: Expression
  description:
    v: Funding Source/Sponsor Protocol and Funding Source/Sponsor Name
  name:
    v: otherOrgProtocolWithNameOneRepetition
  language:
    v: text/fhirpath
  expression:
    v: %otherOrgProtocolOneRepetition + ' (' + %otherOrgNameOneRepetition + ')'

v: in5

v: Other Organization(s) Involved
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/rendering-style
  value:
    v: color:#274e90; font-size: 160%

v: group

v: false

v: true

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: in5.1
text:
  v: Relationship Type
type:
  v: choice
required:
  v: true
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: SFS
    display:
      v: Sponsor or Funding Source
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: CRO
    display:
      v: Contract Research Organization (CRO)
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: in5.1_help
  text:
    v: Select the organization's type of involvement in the study
  type:
    v: display

v: help

v: Help-Button

link id:
  v: in5.2
text:
  v: Organization Name
type:
  v: string
required:
  v: true
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: in5.2_help
  text:
    v: e.g. NIH or company name
  type:
    v: display

v: help

v: Help-Button

link id:
  v: in5.3
text:
  v: Phone
type:
  v: string
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: in5.3_help
  text:
    v: 10 digit phone number, including area code
  type:
    v: display

v: help

v: Help-Button

link id:
  v: in5.4
text:
  v: Sponsor or Funding Source Protocol Number, if applicable
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: in5.4_help
  text:
    v: Unique Protocol Identification Number used by the sponsor, if applicable
  type:
    v: display

v: help

v: Help-Button

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
  value:
    v: true
extension:
  url:
    v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: %combinedOtherOrgUniqueOneRepetition
link id:
  v: in5.5
text:
  v: Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)
type:
  v: string
required:
  v: false
read only:
  v: true

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
  value:
    v: true
extension:
  url:
    v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: %otherOrgProtocolWithNameOneRepetition
link id:
  v: in5.6
text:
  v: Protocol Number with Organization Name (read-only)
type:
  v: string
required:
  v: false
read only:
  v: true

link id:
  v: DIVIDER2
type:
  v: display

link id:
  v: in6
text:
  v: sIRB (Reviewing Institution)
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#274e90; font-size: 160%
type:
  v: group
item:
  link id:
    v: in6.1
  text:
    v: sIRB (Reviewing Institution) Name
  type:
    v: string
  required:
    v: true
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in6.1_help
    text:
      v: Name of the sIRB (Reviewing Institution)
    type:
      v: display
item:
  link id:
    v: in6.10
  text:
    v: Department Name or Division
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in6.10_help
    text:
      v: The department name or division of the sIRB, if applicable
    type:
      v: display
item:
  link id:
    v: in6.3
  text:
    v: Institution Street Address
  type:
    v: string
  required:
    v: true
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in6.3_help
    text:
      v: Physical address of the sIRB (Reviewing Institution)
    type:
      v: display
item:
  link id:
    v: in6.4
  text:
    v: Institution City
  type:
    v: string
  required:
    v: true
item:
  link id:
    v: in6.5
  text:
    v: Institution State
  type:
    v: string
  required:
    v: true
item:
  link id:
    v: in6.6
  text:
    v: Institution Zip Code
  type:
    v: string
  required:
    v: true
item:
  link id:
    v: in6.7
  text:
    v: Institution Country
  type:
    v: string
  required:
    v: false
  initial:
    value:
      v: United States
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: in6.8
  text:
    v: Is a Federal Wide Assurance (FWA) Number assigned?
  type:
    v: choice
  required:
    v: true
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: NI
      display:
        v: No Information
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: NAV
      display:
        v: temporarily unavailable
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in6.8_help
    text:
      v: DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information".
    type:
      v: display
item:
  link id:
    v: in6.9
  text:
    v: Federal Wide Assurance Number (if assigned)
  type:
    v: integer
  enable when:
    question:
      v: in6.8
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in6.9_help
    text:
      v: If assigned, enter just numeric value of FWA.
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept

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

v: Help-Button

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

v: Help-Button

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

v: Help-Button

v: drop-down

v: Drop down

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

v: Help-Button

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

v: Help-Button

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

v: in6.11

v: Is the sIRB a 3rd party institution?

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
initial selected:
  v: true

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: in6.11_help
text:
  v: Is the sIRB an external 3rd party institution, outside of the lead Principal Investigator institution?
type:
  v: display

link id:
  v: DIVIDER3
type:
  v: display

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: institution for the lead PI
    name:
      v: leadPIInstitutionName
    language:
      v: text/fhirpath
    expression:
      v: iif(%resource.descendants().where(linkId = 'in7.1.1').answer.value.exists(), %resource.descendants().where(linkId = 'in7.1.1').answer.value, ' ')
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: dept for the lead PI
    name:
      v: leadPIDept
    language:
      v: text/fhirpath
    expression:
      v: iif(%resource.descendants().where(linkId = 'in7.1.10').answer.value.exists(), %resource.descendants().where(linkId = 'in7.1.10').answer.value, ' ')
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: first name of the lead PI
    name:
      v: leadPIFirstName
    language:
      v: text/fhirpath
    expression:
      v: iif(%resource.descendants().where(linkId = 'in7.3.1').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.1').answer.value, ' ')
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: last name of the lead PI
    name:
      v: leadPILastName
    language:
      v: text/fhirpath
    expression:
      v: iif(%resource.descendants().where(linkId = 'in7.3.2').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.2').answer.value, ' ')
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: suffix of the lead PI
    name:
      v: leadPISuffix
    language:
      v: text/fhirpath
    expression:
      v: iif(%resource.descendants().where(linkId = 'in7.3.3').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.3').answer.value, ' ')
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: degrees of the lead PI
    name:
      v: leadPIDegrees
    language:
      v: text/fhirpath
    expression:
      v: iif(%resource.descendants().where(linkId = 'in7.3.4').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.4').answer.value, ' ')
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: city of the lead PI
    name:
      v: leadPICity
    language:
      v: text/fhirpath
    expression:
      v: iif(%resource.descendants().where(linkId = 'in7.3.7.2').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.7.2').answer.value, ' ')
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: state of the lead PI
    name:
      v: leadPIState
    language:
      v: text/fhirpath
    expression:
      v: iif(%resource.descendants().where(linkId = 'in7.3.7.3').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.7.3').answer.value, ' ')
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: full name, suffix and degrees for the lead PI
    name:
      v: fullNameDSLeadPI
    language:
      v: text/fhirpath
    expression:
      v: %leadPIFirstName + ' ' + %leadPILastName + ', ' + iif(%leadPISuffix = ' ', '', %leadPISuffix+ ', ') + %leadPIDegrees
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: city and state of the lead PI
    name:
      v: leadPILocation
    language:
      v: text/fhirpath
    expression:
      v: iif(%resource.descendants().where(linkId = 'in7.3.7.2').answer.value.exists(), %leadPICity, ' ') + ', ' + iif(%resource.descendants().where(linkId = 'in7.3.7.3').answer.value.exists(), %leadPIState, ' ')
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: full name, suffix and degrees for the lead PI with the lead PI institution and lead PI dept
    name:
      v: combinedLeadPIUniqueSite
    language:
      v: text/fhirpath
    expression:
      v: %leadPIInstitutionName + ' | ' + %leadPIDept + ' | ' + %fullNameDSLeadPI + ' | ' + %leadPILocation
link id:
  v: in7
text:
  v: Lead Principal Investigator
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color: #274e90; font-size: 160%
type:
  v: group
required:
  v: false
repeats:
  v: false
item:
  link id:
    v: in7.1
  text:
    v: Lead Principal Investigator Institution
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style
      value:
        v: color:#2a623d; font-size: 130%
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: in7.1.1
    text:
      v: Lead Principal Investigator Institution Name
    type:
      v: string
    required:
      v: true
    item:
      extension:
        value: CodeableConcept
      link id:
        v: in7.1.1_help
      text:
        v: Name of institution for the lead principal investigator
      type:
        v: display
  item:
    link id:
      v: in7.1.10
    text:
      v: Department Name or Division
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: in7.1.10_help
      text:
        v: The department name or division of the lead principal investigator
      type:
        v: display
  item:
    link id:
      v: in7.1.3
    text:
      v: Institution Phone

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: string

v: false

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: help
      display:
        v: Help-Button
    text:
      v: Help-Button
link id:
  v: in7.1.3_help
text:
  v: 10-digit phone number, including area code, for the institution of the lead principal investigator
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: in7.1.4
text:
  v: Is a Federal Wide Assurance (FWA) Number assigned?
type:
  v: choice
required:
  v: true
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
    display:
      v: Yes
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
      v: No
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: NI
    display:
      v: No Information
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: NAV
    display:
      v: temporarily unavailable
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: in7.1.4_help
  text:
    v: DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information".
  type:
    v: display

v: help

v: Help-Button

link id:
  v: in7.1.5
text:
  v: Federal Wide Assurance Number (if assigned)
type:
  v: integer
enable when:
  question:
    v: in7.1.4
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
enable behavior:
  v: all
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: in7.1.5_help
  text:
    v: If assigned, enter just numeric value of FWA.
  type:
    v: display

v: help

v: Help-Button

link id:
  v: in7.3
text:
  v: Lead Principal Investigator
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#2a623d; font-size: 130%
type:
  v: group
required:
  v: false
item:
  link id:
    v: in7.3.1
  text:
    v: Lead Principal Investigator First Name
  type:
    v: string
  required:
    v: true
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in7.3.1_help
    text:
      v: First Name or Given Name of the lead PI responsible for the overall study
    type:
      v: display
item:
  link id:
    v: in7.3.2
  text:
    v: Lead Principal Investigator Last Name
  type:
    v: string
  required:
    v: true
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in7.3.2_help
    text:
      v: Last name, surname or family name of the lead PI responsible for the overall study
    type:
      v: display
item:
  link id:
    v: in7.3.3
  text:
    v: Lead Principal Investigator Suffix
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in7.3.3_help
    text:
      v: Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.
    type:
      v: display
item:
  link id:
    v: in7.3.4
  text:
    v: Academic and Professional Degrees associated with the Lead Principal Investigator
  type:
    v: string
  required:
    v: true
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in7.3.4_help
    text:
      v: Academic and Professional degrees associated with the lead principal investigator
    type:
      v: display
item:
  link id:
    v: in7.3.10
  text:
    v: Department Name or Division
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in7.3.10_help
    text:
      v: The department name or division of the lead PI
    type:
      v: display
item:
  link id:
    v: in7.3.5
  text:
    v: Phone
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in7.3.5_help
    text:
      v: 10-digit phone number, including area code, for the lead principal investigator
    type:
      v: display
item:
  link id:
    v: in7.3.6
  text:
    v: Email address
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in7.3.6_help
    text:
      v: Email address associated with the lead principal investigator
    type:
      v: display
item:
  link id:
    v: in7.3.7
  text:
    v: Address of Lead Principal Investigator
  type:
    v: group
  required:
    v: false
  item:
    link id:
      v: in7.3.7.1
    text:
      v: Street Address
    type:
      v: string
    required:
      v: false
    item:
      extension:
        value: CodeableConcept
      link id:
        v: in7.3.7.1_help
      text:
        v: Physical address
      type:
        v: display
  item:
    link id:
      v: in7.3.7.2
    text:
      v: City
    type:
      v: string
    required:
      v: true
  item:
    link id:
      v: in7.3.7.3
    text:
      v: State
    type:
      v: string
    required:
      v: true
  item:
    link id:
      v: in7.3.7.4
    text:
      v: Zip Code

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

v: Help-Button

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

v: Help-Button

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

v: Help-Button

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

v: Help-Button

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

v: Help-Button

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

v: Help-Button

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

v: Help-Button

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

v: string

v: false

link id:
  v: in7.3.7.5
text:
  v: Country
type:
  v: string
required:
  v: false
initial:
  value:
    v: United States

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
  value:
    v: true
extension:
  url:
    v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: %combinedLeadPIUniqueSite
link id:
  v: in7.9
text:
  v: Lead Principal Investigator Unique Site (read-only)
type:
  v: string
required:
  v: false
read only:
  v: true

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
  value:
    v: true
extension:
  url:
    v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: %fullNameDSLeadPI
link id:
  v: in7.10
text:
  v: Lead Principal Investigator Full Name, Suffix and Degrees
type:
  v: string
required:
  v: false
read only:
  v: true

link id:
  v: DIVIDER4
type:
  v: display

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: is this relying site at the lead PI institution
    name:
      v: isSameInstitutionOneRepetition
    language:
      v: text/fhirpath
    expression:
      v: item.descendants().where(linkId = 'in8.5.1').answer.valueCoding.code
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: is this relying site the same as the lead PI site
    name:
      v: isSameSiteOneRepetition
    language:
      v: text/fhirpath
    expression:
      v: item.descendants().where(linkId = 'in8.5.2').answer.valueCoding.code
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: is this relying site PI the same as the lead PI
    name:
      v: isSamePIOneRepetition
    language:
      v: text/fhirpath
    expression:
      v: item.descendants().where(linkId = 'in8.5.3').answer.valueCoding.code
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: is the site functioning as a lead site
    name:
      v: isFunctioningAsLeadOneRepetition
    language:
      v: text/fhirpath
    expression:
      v: item.descendants().where(linkId='in8.5.4').answer.valueCoding.code
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: institution for this relying site PI
    name:
      v: sitePIInstitutionNameOneRepetition
    language:
      v: text/fhirpath
    expression:
      v: iif(item.descendants().where(linkId = 'in8.1.1').answer.valueString.exists(), item.descendants().where(linkId = 'in8.1.1').answer.valueString, ' ')
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: dept for this relying site PI
    name:
      v: sitePIDeptOneRepetition
    language:
      v: text/fhirpath
    expression:
      v: iif(item.descendants().where(linkId = 'in8.1.10').answer.valueString.exists(), item.descendants().where(linkId = 'in8.1.10').answer.valueString, ' ')
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: first name of this relying site PI
    name:
      v: sitePIFirstNameOneRepetition
    language:
      v: text/fhirpath
    expression:
      v: iif(item.descendants().where(linkId = 'in8.3.1').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.1').answer.valueString, ' ')
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: last name of this relying site PI
    name:
      v: sitePILastNameOneRepetition
    language:
      v: text/fhirpath
    expression:
      v: iif(item.descendants().where(linkId = 'in8.3.2').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.2').answer.valueString, ' ')
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: suffix of this relying site PI
    name:
      v: sitePISuffixOneRepetition
    language:
      v: text/fhirpath
    expression:
      v: iif(item.descendants().where(linkId = 'in8.3.3').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.3').answer.valueString, ' ')
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: degrees of this relying site PI
    name:
      v: sitePIDegreesOneRepetition
    language:
      v: text/fhirpath
    expression:
      v: iif(item.descendants().where(linkId = 'in8.3.4').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.4').answer.valueString, ' ')
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: city of the relying site PI
    name:
      v: sitePICityOneRepetition
    language:
      v: text/fhirpath
    expression:
      v: iif(item.descendants().where(linkId = 'in8.3.7.2').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.7.2').answer.valueString, ' ')
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: state of the relying site PI
    name:
      v: sitePIStateOneRepetition
    language:
      v: text/fhirpath
    expression:
      v: iif(item.descendants().where(linkId = 'in8.3.7.3').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.7.3').answer.valueString, ' ')
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: full name, suffix and degrees for this relying site PI
    name:
      v: fullNameDSSitePIOneRepetition
    language:
      v: text/fhirpath
    expression:
      v: %sitePIFirstNameOneRepetition + ' ' + %sitePILastNameOneRepetition + ', ' + iif(%sitePISuffixOneRepetition = ' ', '', %sitePISuffixOneRepetition + ', ') + %sitePIDegreesOneRepetition
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: city and state of the relying site PI
    name:
      v: sitePILocationOneRepetition
    language:
      v: text/fhirpath
    expression:
      v: %sitePICityOneRepetition + ', ' + %sitePIStateOneRepetition
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/variable
  value: Expression
    description:
      v: full name, suffix and degrees for this relying site PI and the relying site PI institution and dept
    name:
      v: combinedSitePIUniqueSiteOneRepetition
    language:
      v: text/fhirpath
    expression:
      v: %sitePIInstitutionNameOneRepetition + ' | ' + %sitePIDeptOneRepetition + ' | ' + %fullNameDSSitePIOneRepetition + ' | ' + %sitePILocationOneRepetition
link id:
  v: in8
text:
  v: Relying Site(s)
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color: #274e90; font-size: 160%
type:
  v: group
required:
  v: false
repeats:
  v: true
item:
  link id:
    v: in8.5
  text:
    v: Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/rendering-style

v: color:#2a623d; font-size: 130%

v: group

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: in8.5.1
text:
  v: Is this relying site at the same institution as where the lead principal investigator is conducting the study?
type:
  v: choice
required:
  v: false
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
    display:
      v: Yes
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
      v: No
  initial selected:
    v: true
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: in8.5.1_help
  text:
    v: This question is optional. It can be used to pre-populate the lead principal investigator institution details if this relying site is at the same institution as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank.
  type:
    v: display

v: help

v: Help-Button

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: drop-down
      display:
        v: Drop down
    text:
      v: Drop down
link id:
  v: in8.5.2
text:
  v: Is this relying site at the same site as where the lead principal investigator is conducting the study?
type:
  v: choice
enable when:
  question:
    v: in8.5.1
  operator:
    v: =
  answer: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
required:
  v: false
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
    display:
      v: Yes
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
      v: No
  initial selected:
    v: true
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: in8.5.2_help
  text:
    v: This question is optional. It can be used to pre-populate the lead principal investigator site details if this relying site is at the same site as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank.
  type:
    v: display

v: help

v: Help-Button

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: drop-down
      display:
        v: Drop down
    text:
      v: Drop down
link id:
  v: in8.5.3
text:
  v: Is the relying site PI for this site the same PI as the lead principal investigator conducting the study?
type:
  v: choice
required:
  v: false
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
    display:
      v: Yes
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
      v: No
  initial selected:
    v: true
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: in8.5.3_help
  text:
    v: This question is optional. It can be used to pre-populate the lead principal investigator details if this relying site PI is the same PI as the lead principal investigator conducting the study. If you do not want pre-population to occur, you may leave this question blank.
  type:
    v: display

v: help

v: Help-Button

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: drop-down
      display:
        v: Drop down
    text:
      v: Drop down
link id:
  v: in8.5.4
text:
  v: Is this relying site also considered to be the lead site for the study?
type:
  v: choice
required:
  v: true
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: Y
    display:
      v: Yes
answer option:
  value: Coding
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0532
    code:
      v: N
    display:
      v: No
  initial selected:
    v: true
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: in8.5.4_help
  text:
    v: Indicator that the lead PI site where the study is being conducted is also participating as this relying site
  type:
    v: display

v: help

v: Help-Button

link id:
  v: in8.1
text:
  v: Relying Site Institution
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#2a623d; font-size: 130%
type:
  v: group
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.1').answer.value)
  link id:
    v: in8.1.1
  text:
    v: Relying Institution Name
  type:
    v: string
  required:
    v: true
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in8.1.1_help
    text:
      v: Name of Institution for which their IRB agrees to rely on the decisions of the reviewing IRB at their own institutions.
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.10').answer.value)
  link id:
    v: in8.1.10
  text:
    v: Department Name or Division
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in8.1.10_help
    text:
      v: The department name or division for the relying site
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.3').answer.value)
  link id:
    v: in8.1.3
  text:
    v: Relying Institution Phone
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in8.1.3_help
    text:
      v: 10-digit phone number, including area code, for the relying institution
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.4').answer.valueCoding)
  link id:
    v: in8.1.4
  text:
    v: Is a Federal Wide Assurance (FWA) Number assigned?
  type:
    v: choice
  required:
    v: true
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: NI
      display:
        v: No Information
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: NAV
      display:
        v: temporarily unavailable
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in8.1.4_help
    text:
      v: DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information".
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.5').answer.value)
  link id:
    v: in8.1.5
  text:
    v: Federal Wide Assurance Number (if assigned)
  type:
    v: integer
  enable when:
    question:
      v: in8.1.4
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  enable behavior:
    v: all
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in8.1.5_help
    text:
      v: If assigned, enter just numeric value of FWA.
    type:
      v: display

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

v: Help-Button

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

v: Help-Button

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

v: Help-Button

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

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: in8.1.6
text:
  v: Reliance Status
type:
  v: choice
required:
  v: true
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: APPROVED
    display:
      v: Approved for reliance
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: DENIED
    display:
      v: Denied reliance
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: POSSIBLE
    display:
      v: Potential/possible
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: CANCELLED
    display:
      v: Cancelled or not participating
answer option:
  value: Coding
    system:
      v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
    code:
      v: ONHOLD
    display:
      v: Temporarily on hold
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Help-Button
  link id:
    v: in8.1.6_help
  text:
    v: Status of the reliance agreement
  type:
    v: display

v: help

v: Help-Button

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: help
      display:
        v: Help-Button
    text:
      v: Help-Button
link id:
  v: in8.1_help
text:
  v: Institution whose IRB agrees to rely on oversite by the sIRB (Reviewing IRB)
type:
  v: display

link id:
  v: in8.3
text:
  v: Relying Site Principal Investigator
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#2a623d; font-size: 130%
type:
  v: group
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.1').answer.value)
  link id:
    v: in8.3.1
  text:
    v: Relying Site Principal Investigator First Name
  type:
    v: string
  required:
    v: true
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in8.3.1_help
    text:
      v: First Name or Given Name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.2').answer.value)
  link id:
    v: in8.3.2
  text:
    v: Relying Site Principal Investigator Last Name
  type:
    v: string
  required:
    v: true
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in8.3.2_help
    text:
      v: Last name, surname or family name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.3').answer.value)
  link id:
    v: in8.3.3
  text:
    v: Relying Site Principal Investigator Suffix
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in8.3.3_help
    text:
      v: Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.4').answer.value)
  link id:
    v: in8.3.4
  text:
    v: Academic and Professional Degrees associated with the Relying Site Principal Investigator
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in8.3.4_help
    text:
      v: Academic and Professional degrees associated with the relying site principal investigator
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.10').answer.value)
  link id:
    v: in8.3.10
  text:
    v: Department Name or Division
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in8.3.10_help
    text:
      v: The department name or division for the relying site PI
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.5').answer.value)
  link id:
    v: in8.3.5
  text:
    v: Phone
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in8.3.5_help
    text:
      v: 10-digit phone number, including area code, for the relying site principal investigator
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.6').answer.value)
  link id:
    v: in8.3.6
  text:
    v: Email address
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept

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

v: Help-Button

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

v: Help-Button

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

v: Help-Button

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

v: Help-Button

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

v: Help-Button

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

v: Help-Button

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

v: Help-Button

v: in8.3.6_help

v: Email address associated with the relying site principal investigator

v: display

link id:
  v: in8.3.7
text:
  v: Address of Relying Site Principal Investigator
type:
  v: group
required:
  v: false
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.1').answer.value)
  link id:
    v: in8.3.7.1
  text:
    v: Street Address
  type:
    v: string
  required:
    v: false
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in8.3.7.1_help
    text:
      v: Physical address
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.2').answer.value)
  link id:
    v: in8.3.7.2
  text:
    v: City
  type:
    v: string
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.3').answer.value)
  link id:
    v: in8.3.7.3
  text:
    v: State
  type:
    v: string
item:
  extension:
    url:
      v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
    value: Expression
      language:
        v: text/fhirpath
      expression:
        v: iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.4').answer.value)
  link id:
    v: in8.3.7.4
  text:
    v: Zip Code
  type:
    v: string
  required:
    v: false
item:
  link id:
    v: in8.3.7.5
  text:
    v: Country
  type:
    v: string
  required:
    v: false
  initial:
    value:
      v: United States

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

v: Help-Button

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/questionnaire-item-control
      code:
        v: help
      display:
        v: Help-Button
    text:
      v: Help-Button
link id:
  v: in8.3_help
text:
  v: Principal Investigator responsible for the conduct of the study at a specific relying site research location.
type:
  v: display

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
  value:
    v: true
extension:
  url:
    v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: %combinedSitePIUniqueSiteOneRepetition
link id:
  v: in8.9
text:
  v: Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only)
type:
  v: string
required:
  v: false
read only:
  v: true

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
  value:
    v: true
extension:
  url:
    v: http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression
  value: Expression
    language:
      v: text/fhirpath
    expression:
      v: %fullNameDSSitePIOneRepetition
link id:
  v: in8.10
text:
  v: Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only)
type:
  v: string
required:
  v: false
read only:
  v: true

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: in8_help
text:
  v: The research site(s) where the Lead Principal Investigator is conducting research should also be entered as relying site(s) here, even if at the same institution as entered above for the Lead Principal Investigator. If the Lead Principal Investigator is only managing a coordinating center or other administrative office for the study, do not enter the site again here.
type:
  v: display

link id:
  v: DIVIDER5
type:
  v: display

link id:
  v: in9
text:
  v: FDA exemption and IDE/IND Number
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/rendering-style
    value:
      v: color:#274e90; font-size: 160%
type:
  v: group
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: in9.1
  text:
    v: Does this study require a FDA exemption?
  type:
    v: choice
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in9.1_help
    text:
      v: Indicator for use of FDA regulated product
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: in9.2
  text:
    v: Is an IND or IDE being used in this study?
  type:
    v: choice
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
  answer option:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: N
      display:
        v: No
  item:
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
      value: CodeableConcept
    link id:
      v: in9.2_help
    text:
      v: Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?
    type:
      v: display
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl
    value: CodeableConcept
      text:
        v: Drop down
  link id:
    v: in9.4
  text:
    v: Please select IND or IDE:
  type:
    v: choice
  enable when:
    question:
      v: in9.2
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  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
    link id:
      v: in9.4_help
    text:
      v: Select IND for Investigational New Drug or IDE for Investigational Device Exemption
    type:
      v: display
item:
  link id:
    v: in9.3
  text:
    v: IND/IDE Number
  type:
    v: string
  enable when:
    question:
      v: in9.2
    operator:
      v: =
    answer: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
  required:
    v: false

v: drop-down

v: Drop down

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

v: Help-Button

v: drop-down

v: Drop down

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

v: Help-Button

v: drop-down

v: Drop down

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

v: Help-Button

link id:
  v: DIVIDER6
type:
  v: display

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
  value:
    v: false
link id:
  v: in10
text:
  v: Questionnaire Version Details
type:
  v: group
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
    value:
      v: false
  link id:
    v: in10.1
  text:
    v: Questionnaire Version
  type:
    v: string
  required:
    v: true
  read only:
    v: true
  initial:
    value:
      v: 2
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
    value:
      v: false
  link id:
    v: in10.2
  text:
    v: Questionnaire Version Date
  type:
    v: date
  required:
    v: true
  read only:
    v: true
  initial:
    value:
      v: 2021-10-18

link id:
  v: DIVIDER7
type:
  v: display

extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
  value:
    v: true
link id:
  v: ADMIN00
text:
  v: Administrative Use Only (will be hidden in the future)
type:
  v: group
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
    value:
      v: true
  link id:
    v: ADMIN01
  text:
    v: Link ID prefix
  type:
    v: string
  required:
    v: false
  initial:
    value:
      v: in
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
    value:
      v: true
  link id:
    v: ADMIN02
  text:
    v: Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any
  type:
    v: string
  required:
    v: false
  initial:
    value:
      v: temporarily unavailable
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
    value:
      v: true
  link id:
    v: ADMIN03
  text:
    v: ID of the Research Study FHIR Resource associated with the study Questionnaire Responses
  type:
    v: string
  required:
    v: false
  initial:
    value:
      v: temporarily unavailable
item:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/questionnaire-hidden
    value:
      v: true
  link id:
    v: ADMIN04
  text:
    v: Questionnaire Response ID of the local considerations Questionnaire Response, if any
  type:
    v: string
  required:
    v: false