initiate-study-populate-exampleQR
type: QuestionnaireResponse
node role: treeRoot
id:
  v: initiate-study-populate-exampleQR
meta:
  version id:
    v: 3
  last updated:
    v: 2022-02-25T22:56:02.598+00:00
text:
  status:
    v: generated
  div: LinkId Text Definition Answer<img src="[binary]" alt="doco" style="background-color: inherit"/> initiate-study-populate-exampleQR QuestionnaireResponse in1 Research Study Details in1.1 Study Title A clinical study of the efficacy of Drug A for arthritis in1.2 Study Title (Short) Study of Drug A for arthritis in1.3 IRB Protocol Number PRO098765 in1.4 Study Type Temporary Codes INT: Interventional in5 Other Organization(s) Involved in5.1 Relationship Type Temporary Codes SFS: Sponsor or Funding Source in5.2 Organization Name National Government Funder in5.3 Phone 800-123-1234 in5.4 Sponsor or Funding Source Protocol Number, if applicable Gov-123456 in5.5 Other Organization Name, Relationship Type, Phone and Protocol Number (read-only) National Government Funder | 800-123-1234 | Gov-123456 | Sponsor or Funding Source in5.6 Protocol Number with Organization Name (read-only) Gov-123456 (National Government Funder) in5 Other Organization(s) Involved in5.1 Relationship Type Temporary Codes SFS: Sponsor or Funding Source in5.2 Organization Name Organization of Arthritis Patients Foundation in5.3 Phone 123-123-1234 in5.5 Other Organization Name, Relationship Type, Phone and Protocol Number (read-only) Organization of Arthritis Patients Foundation | 123-123-1234 | | Sponsor or Funding Source in5.6 Protocol Number with Organization Name (read-only) (Organization of Arthritis Patients Foundation) in5 Other Organization(s) Involved in5.1 Relationship Type Temporary Codes CRO: Contract Research Organization (CRO) in5.2 Organization Name Sample CRO, Inc. in5.3 Phone 234-123-1234 in5.5 Other Organization Name, Relationship Type, Phone and Protocol Number (read-only) Sample CRO, Inc. | 234-123-1234 | | Contract Research Organization (CRO) in5.6 Protocol Number with Organization Name (read-only) (Sample CRO, Inc.) in6 sIRB (Reviewing Institution) in6.1 sIRB (Reviewing Institution) Name X Pharmaceutical Research IRB in6.3 Institution Street Address 210 Research Drive in6.4 Institution…
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/workflow-researchStudy
  value: Reference
    link: http://hl7.org/fhir/us/sirb/ResearchStudy/ResearchStudyExample-sIRB
    reference:
      v: ResearchStudy/ResearchStudyExample-sIRB
    display:
      v: ResearchStudyExample-sIRB
questionnaire:
  v: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire-populate
  link: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire-populate
status:
  v: completed
authored:
  v: 2022-02-25T22:55:38.773Z
item:
  link id:
    v: in1
  text:
    v: Research Study Details
  item:
    link id:
      v: in1.1
    text:
      v: Study Title
    answer:
      value:
        v: A clinical study of the efficacy of Drug A for arthritis
  item:
    link id:
      v: in1.2
    text:
      v: Study Title (Short)
    answer:
      value:
        v: Study of Drug A for arthritis
  item:
    link id:
      v: in1.3
    text:
      v: IRB Protocol Number
    answer:
      value:
        v: PRO098765
  item:
    link id:
      v: in1.4
    text:
      v: Study Type
    answer:
      value: Coding
item:
  link id:
    v: in5
  text:
    v: Other Organization(s) Involved
  item:
    link id:
      v: in5.1
    text:
      v: Relationship Type
    answer:
      value: Coding
  item:
    link id:
      v: in5.2
    text:
      v: Organization Name
    answer:
      value:
        v: National Government Funder
  item:
    link id:
      v: in5.3
    text:
      v: Phone
    answer:
      value:
        v: 800-123-1234
  item:
    link id:
      v: in5.4
    text:
      v: Sponsor or Funding Source Protocol Number, if applicable
    answer:
      value:
        v: Gov-123456
  item:
    link id:
      v: in5.5
    text:
      v: Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)
    answer:
      value:
        v: National Government Funder | 800-123-1234 | Gov-123456 | Sponsor or Funding Source
  item:
    link id:
      v: in5.6
    text:
      v: Protocol Number with Organization Name (read-only)
    answer:
      value:
        v: Gov-123456 (National Government Funder)
item:
  link id:
    v: in5
  text:
    v: Other Organization(s) Involved
  item:
    link id:
      v: in5.1
    text:
      v: Relationship Type
    answer:
      value: Coding
  item:
    link id:
      v: in5.2
    text:
      v: Organization Name
    answer:
      value:
        v: Organization of Arthritis Patients Foundation
  item:
    link id:
      v: in5.3
    text:
      v: Phone
    answer:
      value:
        v: 123-123-1234
  item:
    link id:
      v: in5.5
    text:
      v: Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)
    answer:
      value:
        v: Organization of Arthritis Patients Foundation | 123-123-1234 | | Sponsor or Funding Source
  item:
    link id:
      v: in5.6
    text:
      v: Protocol Number with Organization Name (read-only)
    answer:
      value:
        v: (Organization of Arthritis Patients Foundation)
item:
  link id:
    v: in5
  text:
    v: Other Organization(s) Involved
  item:
    link id:
      v: in5.1
    text:
      v: Relationship Type
    answer:
      value: Coding
  item:
    link id:
      v: in5.2
    text:
      v: Organization Name
    answer:
      value:
        v: Sample CRO, Inc.
  item:
    link id:
      v: in5.3
    text:
      v: Phone
    answer:
      value:
        v: 234-123-1234
  item:
    link id:
      v: in5.5
    text:
      v: Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)
    answer:
      value:
        v: Sample CRO, Inc. | 234-123-1234 | | Contract Research Organization (CRO)
  item:
    link id:
      v: in5.6
    text:
      v: Protocol Number with Organization Name (read-only)

v: INT

v: Interventional

v: SFS

v: Sponsor or Funding Source

v: SFS

v: Sponsor or Funding Source

v: CRO

v: Contract Research Organization (CRO)

value:
  v: (Sample CRO, Inc.)

link id:
  v: in6
text:
  v: sIRB (Reviewing Institution)
item:
  link id:
    v: in6.1
  text:
    v: sIRB (Reviewing Institution) Name
  answer:
    value:
      v: X Pharmaceutical Research IRB
item:
  link id:
    v: in6.3
  text:
    v: Institution Street Address
  answer:
    value:
      v: 210 Research Drive
item:
  link id:
    v: in6.4
  text:
    v: Institution City
  answer:
    value:
      v: Sample City
item:
  link id:
    v: in6.5
  text:
    v: Institution State
  answer:
    value:
      v: NC
item:
  link id:
    v: in6.6
  text:
    v: Institution Zip Code
  answer:
    value:
      v: 27612
item:
  link id:
    v: in6.7
  text:
    v: Institution Country
  answer:
    value:
      v: United States
item:
  link id:
    v: in6.8
  text:
    v: Is a Federal Wide Assurance (FWA) Number assigned?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: in6.9
  text:
    v: Federal Wide Assurance Number (if assigned)
  answer:
    value:
      v: 12345
item:
  link id:
    v: in6.11
  text:
    v: Is the sIRB a 3rd party institution?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes

link id:
  v: in7
text:
  v: Lead Principal Investigator
item:
  link id:
    v: in7.1
  text:
    v: Lead Principal Investigator Institution
  item:
    link id:
      v: in7.1.1
    text:
      v: Lead Principal Investigator Institution Name
    answer:
      value:
        v: Sample University Medical Center
  item:
    link id:
      v: in7.1.4
    text:
      v: Is a Federal Wide Assurance (FWA) Number assigned?
    answer:
      value: Coding
  item:
    link id:
      v: in7.1.5
    text:
      v: Federal Wide Assurance Number (if assigned)
    answer:
      value:
        v: 56789
item:
  link id:
    v: in7.3
  text:
    v: Lead Principal Investigator
  item:
    link id:
      v: in7.3.1
    text:
      v: Lead Principal Investigator First Name
    answer:
      value:
        v: Jane
  item:
    link id:
      v: in7.3.2
    text:
      v: Lead Principal Investigator Last Name
    answer:
      value:
        v: Doe
  item:
    link id:
      v: in7.3.4
    text:
      v: Academic and Professional Degrees associated with the Lead Principal Investigator
    answer:
      value:
        v: MD
  item:
    link id:
      v: in7.3.10
    text:
      v: Department Name or Division
    answer:
      value:
        v: Orthopedics
  item:
    link id:
      v: in7.3.5
    text:
      v: Phone
    answer:
      value:
        v: 567-123-1234
  item:
    link id:
      v: in7.3.6
    text:
      v: Email address
  item:
    link id:
      v: in7.3.7
    text:
      v: Address of Lead Principal Investigator
    item:
      link id:
        v: in7.3.7.1
      text:
        v: Street Address
    item:
      link id:
        v: in7.3.7.2
      text:
        v: City
    item:
      link id:
        v: in7.3.7.3
      text:
        v: State
    item:
      link id:
        v: in7.3.7.4
      text:
        v: Zip Code
    item:
      link id:
        v: in7.3.7.5
      text:
        v: Country
item:
  link id:
    v: in7.9
  text:
    v: Lead Principal Investigator Unique Site (read-only)
  answer:
    value:
      v: Sample University Medical Center | | Jane Doe, MD | Sample City, NC
item:
  link id:
    v: in7.10
  text:
    v: Lead Principal Investigator Full Name, Suffix and Degrees
  answer:
    value:
      v: Jane Doe, MD

v: Y

v: Yes

v: 105 Sample University Ct.

v: Sample City

v: NC

v: 27612

v: United States

link id:
  v: in8
text:
  v: Relying Site(s)
item:
  link id:
    v: in8.5
  text:
    v: Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator
  item:
    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?
    answer:
      value: Coding
  item:
    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?
    answer:
      value: Coding
  item:
    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?
    answer:
      value: Coding
  item:
    link id:
      v: in8.5.4
    text:
      v: Is this relying site also considered to be the lead site for the study?
    answer:
      value: Coding
item:
  link id:
    v: in8.1
  text:
    v: Relying Site Institution
  item:
    link id:
      v: in8.1.1
    text:
      v: Relying Institution Name
    answer:
      value:
        v: Sample University Medical Center
  item:
    link id:
      v: in8.1.4
    text:
      v: Is a Federal Wide Assurance (FWA) Number assigned?
    answer:
      value: Coding
  item:
    link id:
      v: in8.1.5
    text:
      v: Federal Wide Assurance Number (if assigned)
    answer:
      value:
        v: 56789
  item:
    link id:
      v: in8.1.6
    text:
      v: Reliance Status
    answer:
      value: Coding
item:
  link id:
    v: in8.3
  text:
    v: Relying Site Principal Investigator
  item:
    link id:
      v: in8.3.1
    text:
      v: Relying Site Principal Investigator First Name
    answer:
      value:
        v: Jane
  item:
    link id:
      v: in8.3.2
    text:
      v: Relying Site Principal Investigator Last Name
    answer:
      value:
        v: Doe
  item:
    link id:
      v: in8.3.4
    text:
      v: Academic and Professional Degrees associated with the Relying Site Principal Investigator
    answer:
      value:
        v: MD
  item:
    link id:
      v: in8.3.10
    text:
      v: Department Name or Division
    answer:
      value:
        v: Orthopedics
  item:
    link id:
      v: in8.3.5
    text:
      v: Phone
    answer:
      value:
        v: 567-123-1234
  item:
    link id:
      v: in8.3.6
    text:
      v: Email address
  item:
    link id:
      v: in8.3.7
    text:
      v: Address of Relying Site Principal Investigator
    item:
      link id:
        v: in8.3.7.1
      text:
        v: Street Address
    item:
      link id:
        v: in8.3.7.2
      text:
        v: City
    item:
      link id:
        v: in8.3.7.3
      text:
        v: State
    item:
      link id:
        v: in8.3.7.4
      text:
        v: Zip Code
    item:
      link id:
        v: in8.3.7.5
      text:
        v: Country
item:
  link id:
    v: in8.9
  text:
    v: Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only)
  answer:
    value:
      v: Sample University Medical Center | | Jane Doe, MD | Sample City, NC
item:
  link id:
    v: in8.10
  text:
    v: Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only)
  answer:
    value:
      v: Jane Doe, MD

v: Y

v: Yes

v: Y

v: Yes

v: Y

v: Yes

v: Y

v: Yes

v: Y

v: Yes

v: APPROVED

v: Approved for reliance

v: 105 Sample University Ct.

v: Sample City

v: NC

v: 27612

v: United States

link id:
  v: in8
text:
  v: Relying Site(s)
item:
  link id:
    v: in8.5
  text:
    v: Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator
  item:
    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?
    answer:
      value: Coding
  item:
    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?
    answer:
      value: Coding
  item:
    link id:
      v: in8.5.4
    text:
      v: Is this relying site also considered to be the lead site for the study?
    answer:
      value: Coding
item:
  link id:
    v: in8.1
  text:
    v: Relying Site Institution
  item:
    link id:
      v: in8.1.1
    text:
      v: Relying Institution Name
    answer:
      value:
        v: Test Example University
  item:
    link id:
      v: in8.1.3
    text:
      v: Relying Institution Phone
    answer:
      value:
        v: 6781233456
  item:
    link id:
      v: in8.1.4
    text:
      v: Is a Federal Wide Assurance (FWA) Number assigned?
    answer:
      value: Coding
  item:
    link id:
      v: in8.1.5
    text:
      v: Federal Wide Assurance Number (if assigned)
    answer:
      value:
        v: 34567
  item:
    link id:
      v: in8.1.6
    text:
      v: Reliance Status
    answer:
      value: Coding
item:
  link id:
    v: in8.3
  text:
    v: Relying Site Principal Investigator
  item:
    link id:
      v: in8.3.1
    text:
      v: Relying Site Principal Investigator First Name
    answer:
      value:
        v: Xi-Yang
  item:
    link id:
      v: in8.3.2
    text:
      v: Relying Site Principal Investigator Last Name
    answer:
      value:
        v: Lee
  item:
    link id:
      v: in8.3.3
    text:
      v: Relying Site Principal Investigator Suffix
    answer:
      value:
        v: Jr.
  item:
    link id:
      v: in8.3.4
    text:
      v: Academic and Professional Degrees associated with the Relying Site Principal Investigator
    answer:
      value:
        v: MD, PhD
  item:
    link id:
      v: in8.3.5
    text:
      v: Phone
    answer:
      value:
        v: 6781233456
  item:
    link id:
      v: in8.3.6
    text:
      v: Email address
  item:
    link id:
      v: in8.3.7
    text:
      v: Address of Relying Site Principal Investigator
    item:
      link id:
        v: in8.3.7.1
      text:
        v: Street Address
    item:
      link id:
        v: in8.3.7.2
      text:
        v: City
    item:
      link id:
        v: in8.3.7.3
      text:
        v: State
    item:
      link id:
        v: in8.3.7.4
      text:
        v: Zip Code
    item:
      link id:
        v: in8.3.7.5
      text:
        v: Country
item:
  link id:
    v: in8.9
  text:
    v: Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only)
  answer:
    value:
      v: Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA
item:
  link id:
    v: in8.10
  text:
    v: Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only)
  answer:
    value:
      v: Xi-Yang Lee, Jr., MD, PhD

v: N

v: No

v: N

v: No

v: N

v: No

v: Y

v: Yes

v: POSSIBLE

v: Potential/possible

v: 200 Test Example Circle

v: Example

v: MA

v: 67890

v: United States

link id:
  v: in8
text:
  v: Relying Site(s)
item:
  link id:
    v: in8.5
  text:
    v: Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator
  item:
    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?
    answer:
      value: Coding
  item:
    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?
    answer:
      value: Coding
  item:
    link id:
      v: in8.5.4
    text:
      v: Is this relying site also considered to be the lead site for the study?
    answer:
      value: Coding
item:
  link id:
    v: in8.1
  text:
    v: Relying Site Institution
  item:
    link id:
      v: in8.1.1
    text:
      v: Relying Institution Name
    answer:
      value:
        v: Central Campus Test University
  item:
    link id:
      v: in8.1.4
    text:
      v: Is a Federal Wide Assurance (FWA) Number assigned?
    answer:
      value: Coding
  item:
    link id:
      v: in8.1.6
    text:
      v: Reliance Status
    answer:
      value: Coding
item:
  link id:
    v: in8.3
  text:
    v: Relying Site Principal Investigator
  item:
    link id:
      v: in8.3.1
    text:
      v: Relying Site Principal Investigator First Name
    answer:
      value:
        v: Maria
  item:
    link id:
      v: in8.3.2
    text:
      v: Relying Site Principal Investigator Last Name
    answer:
      value:
        v: Smith
  item:
    link id:
      v: in8.3.4
    text:
      v: Academic and Professional Degrees associated with the Relying Site Principal Investigator
    answer:
      value:
        v: PhD
  item:
    link id:
      v: in8.3.5
    text:
      v: Phone
    answer:
      value:
        v: 8901231234
  item:
    link id:
      v: in8.3.6
    text:
      v: Email address
  item:
    link id:
      v: in8.3.7
    text:
      v: Address of Relying Site Principal Investigator
    item:
      link id:
        v: in8.3.7.1
      text:
        v: Street Address
    item:
      link id:
        v: in8.3.7.2
      text:
        v: City
    item:
      link id:
        v: in8.3.7.3
      text:
        v: State
    item:
      link id:
        v: in8.3.7.4
      text:
        v: Zip Code
    item:
      link id:
        v: in8.3.7.5
      text:
        v: Country
item:
  link id:
    v: in8.9
  text:
    v: Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only)
  answer:
    value:
      v: Central Campus Test University | | Maria Smith, PhD | Central, MI
item:
  link id:
    v: in8.10
  text:
    v: Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only)
  answer:
    value:
      v: Maria Smith, PhD

v: N

v: No

v: N

v: No

v: N

v: No

v: NI

v: No Information

v: POSSIBLE

v: Potential/possible

v: 200 Central St.

v: Central

v: MI

v: 23456

v: United States

link id:
  v: in9
text:
  v: FDA exemption and IDE/IND Number
item:
  link id:
    v: in9.1
  text:
    v: Does this study require a FDA exemption?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: in9.2
  text:
    v: Is an IND or IDE being used in this study?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: in9.4
  text:
    v: Please select IND or IDE:
  answer:
    value: Coding
      system:
        v: http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes
      code:
        v: IND
      display:
        v: IND
item:
  link id:
    v: in9.3
  text:
    v: IND/IDE Number
  answer:
    value:
      v: 432fdw512432fqsdf

link id:
  v: in10
text:
  v: Questionnaire Version Details
item:
  link id:
    v: in10.1
  text:
    v: Questionnaire Version
  answer:
    value:
      v: 2
item:
  link id:
    v: in10.2
  text:
    v: Questionnaire Version Date
  answer:
    value:
      v: 2021-10-18

link id:
  v: ADMIN00
text:
  v: Administrative Use Only (will be hidden in the future)
item:
  link id:
    v: ADMIN01
  text:
    v: Link ID prefix
  answer:
    value:
      v: in
item:
  link id:
    v: ADMIN02
  text:
    v: Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any
  answer:
    value:
      v: initiate-study-populate-exampleQR
item:
  link id:
    v: ADMIN03
  text:
    v: ID of the Research Study FHIR Resource associated with the study Questionnaire Responses
  answer:
    value:
      v: ResearchStudyExample-sIRB