continuing-review-populate-exampleQR
type: QuestionnaireResponse
node role: treeRoot
id:
  v: continuing-review-populate-exampleQR
meta:
  version id:
    v: 1
  last updated:
    v: 2022-02-28T01:27:32.888+00:00
text:
  status:
    v: generated
  div: LinkId Text Definition Answer<img src="[binary]" alt="doco" style="background-color: inherit"/> continuing-review-populate-exampleQR QuestionnaireResponse cr1 Research Study cr1.1 Study Title Study of Drug A for arthritis cr1.2 IRB Protocol Number PRO098765 cr1.3 Enrollment Status Temporary Codes open: Open for enrollment cr1.4 Intervention Status Temporary Codes continue-meds: Continuing interventions cr1.5 Study Status ResearchStudyStatus active: Active cr1.6 Funding Source(check all that are applicable) Temporary Codes federal: Federal cr12 sIRB (Reviewing Institution) cr12.1 sIRB (Reviewing Institution) Name X Pharmaceutical Research IRB cr9 Submission Type cr9.1 Is this Continuing Review Form being submitted by the lead PI site on behalf of all of the relying sites? expandedYes-NoIndicator Y: Yes ExternalDataFor_cr9.2 External Data For linkId cr9.2 cr11 Site Principal Investigator Institution cr11.1 Site Principal Investigator Institution Name Sample University Medical Center cr2 Site Principal Investigator cr2.1 First Name Jane cr2.4 Last Name Doe cr2.6 Degree(s) MD cr2.10 Site Principal Investigator Department Name or Division Orthopedics cr2.2 Phone 567-123-1234 cr2.3 Email drjanedoe@sampleuniversity.edu cr3 Accrual of Participants cr3.1 Provide counts for the following cr3.1.1 Participants enrolled since activation cr3.1.1.1 Previous Accrual 10 cr3.1.1.2 Additional enrollees this approval period 20 cr3.1.1.3 Total 30 cr3.1.2 Participants enrolled since last approval cr3.1.2.1 Previous Accrual 10 cr3.1.2.2 Additional enrollees this approval period 10 cr3.1.2.3 Total 20 cr3.1.3 Participants approved to enroll cr3.1.3.1 Previous Accrual 10 cr3.1.3.2 Additional enrollees this approval period 10 cr3.1.3.3 Total 20 cr3.1.4 Participants consented cr3.1.4.1 Previous Accrual 10 cr3.1.4.2 Additional enrollees this approval period 10 cr3.1.4.3 Total 20 cr3.1.5 Participants withdrawn cr3.1.5.1 Previous Accrual 0 cr3.1.5.2 Additional enrollees this approval period 0 cr3…
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-continuing-review-questionnaire-populate
  link: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire-populate
status:
  v: completed
authored:
  v: 2022-02-28T01:27:32.100Z
item:
  link id:
    v: cr1
  text:
    v: Research Study
  item:
    link id:
      v: cr1.1
    text:
      v: Study Title
    answer:
      value:
        v: Study of Drug A for arthritis
  item:
    link id:
      v: cr1.2
    text:
      v: IRB Protocol Number
    answer:
      value:
        v: PRO098765
  item:
    link id:
      v: cr1.3
    text:
      v: Enrollment Status
    answer:
      value: Coding
  item:
    link id:
      v: cr1.4
    text:
      v: Intervention Status
    answer:
      value: Coding
  item:
    link id:
      v: cr1.5
    text:
      v: Study Status
    answer:
      value: Coding
  item:
    link id:
      v: cr1.6
    text:
      v: Funding Source(check all that are applicable)
    answer:
      value: Coding
item:
  link id:
    v: cr12
  text:
    v: sIRB (Reviewing Institution)
  item:
    link id:
      v: cr12.1
    text:
      v: sIRB (Reviewing Institution) Name
    answer:
      value:
        v: X Pharmaceutical Research IRB
item:
  link id:
    v: cr9
  text:
    v: Submission Type
  item:
    link id:
      v: cr9.1
    text:
      v: Is this Continuing Review Form being submitted by the lead PI site on behalf of all of the relying sites?
    answer:
      value: Coding
  item:
    link id:
      v: ExternalDataFor_cr9.2
    text:
      v: External Data For linkId cr9.2
    answer:
      value:
        v: Sample University Medical Center | | Jane Doe, MD | Sample City, NC
    answer:
      value:
        v: Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA
    answer:
      value:
        v: Central Campus Test University | | Maria Smith, PhD | Central, MI
item:
  link id:
    v: cr11
  text:
    v: Site Principal Investigator Institution
  item:
    link id:
      v: cr11.1
    text:
      v: Site Principal Investigator Institution Name
    answer:
      value:
        v: Sample University Medical Center
item:
  link id:
    v: cr2
  text:
    v: Site Principal Investigator
  item:
    link id:
      v: cr2.1
    text:
      v: First Name
    answer:
      value:
        v: Jane
  item:
    link id:
      v: cr2.4
    text:
      v: Last Name
    answer:
      value:
        v: Doe
  item:
    link id:
      v: cr2.6
    text:
      v: Degree(s)
    answer:
      value:
        v: MD
  item:
    link id:
      v: cr2.10
    text:
      v: Site Principal Investigator Department Name or Division
    answer:
      value:
        v: Orthopedics
  item:
    link id:
      v: cr2.2
    text:
      v: Phone
    answer:
      value:
        v: 567-123-1234
  item:
    link id:
      v: cr2.3
    text:
      v: Email
item:
  link id:
    v: cr3
  text:
    v: Accrual of Participants
  item:
    link id:
      v: cr3.1
    text:
      v: Provide counts for the following
    item:
      link id:
        v: cr3.1.1
      text:
        v: Participants enrolled since activation
    item:
      link id:
        v: cr3.1.2
      text:
        v: Participants enrolled since last approval
    item:
      link id:
        v: cr3.1.3

v: open

v: Open for enrollment

v: continue-meds

v: Continuing interventions

v: active

v: Active

v: federal

v: Federal

v: Y

v: Yes

v: cr3.1.1.1

v: Previous Accrual

value:
  v: 10

v: cr3.1.1.2

v: Additional enrollees this approval period

value:
  v: 20

v: cr3.1.1.3

v: Total

value:
  v: 30

v: cr3.1.2.1

v: Previous Accrual

value:
  v: 10

v: cr3.1.2.2

v: Additional enrollees this approval period

value:
  v: 10

v: cr3.1.2.3

v: Total

value:
  v: 20

v: Participants approved to enroll

link id:
  v: cr3.1.3.1
text:
  v: Previous Accrual
answer:
  value:
    v: 10

link id:
  v: cr3.1.3.2
text:
  v: Additional enrollees this approval period
answer:
  value:
    v: 10

link id:
  v: cr3.1.3.3
text:
  v: Total
answer:
  value:
    v: 20

link id:
  v: cr3.1.4
text:
  v: Participants consented
item:
  link id:
    v: cr3.1.4.1
  text:
    v: Previous Accrual
  answer:
    value:
      v: 10
item:
  link id:
    v: cr3.1.4.2
  text:
    v: Additional enrollees this approval period
  answer:
    value:
      v: 10
item:
  link id:
    v: cr3.1.4.3
  text:
    v: Total
  answer:
    value:
      v: 20

link id:
  v: cr3.1.5
text:
  v: Participants withdrawn
item:
  link id:
    v: cr3.1.5.1
  text:
    v: Previous Accrual
  answer:
    value:
      v: 0
item:
  link id:
    v: cr3.1.5.2
  text:
    v: Additional enrollees this approval period
  answer:
    value:
      v: 0
item:
  link id:
    v: cr3.1.5.3
  text:
    v: Total
  answer:
    value:
      v: 0

link id:
  v: cr3.1.6
text:
  v: Participants lost to contact
item:
  link id:
    v: cr3.1.6.1
  text:
    v: Previous Accrual
  answer:
    value:
      v: 0
item:
  link id:
    v: cr3.1.6.2
  text:
    v: Additional enrollees this approval period
  answer:
    value:
      v: 0
item:
  link id:
    v: cr3.1.6.3
  text:
    v: Total
  answer:
    value:
      v: 0

link id:
  v: cr3.1.7
text:
  v: Participants with screen failures
item:
  link id:
    v: cr3.1.7.1
  text:
    v: Previous Accrual
  answer:
    value:
      v: 0
item:
  link id:
    v: cr3.1.7.2
  text:
    v: Additional enrollees this approval period
  answer:
    value:
      v: 0
item:
  link id:
    v: cr3.1.7.3
  text:
    v: Total
  answer:
    value:
      v: 0

link id:
  v: cr3.1.8
text:
  v: Participants still active or follow-up
item:
  link id:
    v: cr3.1.8.1
  text:
    v: Previous Accrual
  answer:
    value:
      v: 10
item:
  link id:
    v: cr3.1.8.2
  text:
    v: Additional enrollees this approval period
  answer:
    value:
      v: 10
item:
  link id:
    v: cr3.1.8.3
  text:
    v: Total
  answer:
    value:
      v: 20

link id:
  v: cr3.1.9
text:
  v: Participants completed study
item:
  link id:
    v: cr3.1.9.1
  text:
    v: Previous Accrual
  answer:
    value:
      v: 5
item:
  link id:
    v: cr3.1.9.2
  text:
    v: Additional enrollees this approval period
  answer:
    value:
      v: 0
item:
  link id:
    v: cr3.1.9.3
  text:
    v: Total
  answer:
    value:
      v: 5

link id:
  v: cr3.1.10
text:
  v: By Sex
item:
  link id:
    v: cr3.1.10.1
  text:
    v: Men
  item:
    link id:
      v: cr3.1.10.1.1
    text:
      v: Previous Accrual
    answer:
      value:
        v: 6
  item:
    link id:
      v: cr3.1.10.1.2
    text:
      v: Additional enrollees this approval period
    answer:
      value:
        v: 5
  item:
    link id:
      v: cr3.1.10.1.3
    text:
      v: Total
    answer:
      value:
        v: 11
item:
  link id:
    v: cr3.1.10.2
  text:
    v: Women
  item:
    link id:
      v: cr3.1.10.2.1
    text:
      v: Previous Accrual
    answer:
      value:
        v: 4
  item:
    link id:
      v: cr3.1.10.2.2
    text:
      v: Additional enrollees this approval period
    answer:
      value:
        v: 15
  item:
    link id:
      v: cr3.1.10.2.3
    text:
      v: Total
    answer:
      value:
        v: 19

link id:
  v: cr3.1.11
text:
  v: By Race
item:
  link id:
    v: cr3.1.11.1
  text:
    v: White
  item:
    link id:
      v: cr3.1.11.1.1
    text:
      v: Previous Accrual
    answer:
      value:
        v: 3
  item:
    link id:
      v: cr3.1.11.1.2
    text:
      v: Additional enrollees this approval period
    answer:
      value:
        v: 3
  item:
    link id:
      v: cr3.1.11.1.3
    text:
      v: Total
    answer:
      value:
        v: 6
item:
  link id:
    v: cr3.1.11.2
  text:
    v: Black or African American
  item:
    link id:
      v: cr3.1.11.2.1
    text:
      v: Previous Accrual
    answer:
      value:
        v: 3
  item:
    link id:
      v: cr3.1.11.2.2
    text:
      v: Additional enrollees this approval period
    answer:
      value:
        v: 4
  item:
    link id:
      v: cr3.1.11.2.3
    text:
      v: Total
    answer:
      value:
        v: 7
item:
  link id:
    v: cr3.1.11.3
  text:
    v: Asian
  item:
    link id:
      v: cr3.1.11.3.1
    text:
      v: Previous Accrual
    answer:
      value:
        v: 2
  item:
    link id:
      v: cr3.1.11.3.2
    text:
      v: Additional enrollees this approval period
    answer:
      value:
        v: 3
  item:
    link id:
      v: cr3.1.11.3.3
    text:
      v: Total
    answer:
      value:
        v: 5
item:
  link id:
    v: cr3.1.11.4
  text:
    v: American Indian or Alaska Native
  item:
    link id:
      v: cr3.1.11.4.1
    text:
      v: Previous Accrual
    answer:
      value:
        v: 1
  item:
    link id:
      v: cr3.1.11.4.2
    text:
      v: Additional enrollees this approval period
    answer:
      value:
        v: 0
  item:
    link id:
      v: cr3.1.11.4.3
    text:
      v: Total
    answer:
      value:
        v: 1
item:
  link id:
    v: cr3.1.11.5
  text:
    v: Native Hawaiian or other Pacific Islander
  item:
    link id:
      v: cr3.1.11.5.1
    text:
      v: Previous Accrual
    answer:
      value:
        v: 0
  item:
    link id:
      v: cr3.1.11.5.2
    text:
      v: Additional enrollees this approval period
    answer:
      value:
        v: 1
  item:
    link id:
      v: cr3.1.11.5.3
    text:
      v: Total
    answer:
      value:
        v: 1
item:
  link id:
    v: cr3.1.11.6
  text:
    v: More than One Race
  item:
    link id:
      v: cr3.1.11.6.1
    text:
      v: Previous Accrual
    answer:
      value:
        v: 2
  item:
    link id:
      v: cr3.1.11.6.2
    text:
      v: Additional enrollees this approval period
    answer:
      value:
        v: 0
  item:
    link id:
      v: cr3.1.11.6.3
    text:
      v: Total
    answer:
      value:
        v: 2
item:
  link id:
    v: cr3.1.11.7
  text:
    v: Unknown/Not Reported
  item:
    link id:
      v: cr3.1.11.7.1
    text:
      v: Previous Accrual
    answer:
      value:
        v: 0
  item:
    link id:
      v: cr3.1.11.7.2
    text:
      v: Additional enrollees this approval period
    answer:
      value:
        v: 0
  item:
    link id:
      v: cr3.1.11.7.3

v: Total

value:
  v: 0

link id:
  v: cr3.1.12
text:
  v: By Ethnicity
item:
  link id:
    v: cr3.1.12.1
  text:
    v: Hispanic or Latino
  item:
    link id:
      v: cr3.1.12.1.1
    text:
      v: Previous Accrual
    answer:
      value:
        v: 4
  item:
    link id:
      v: cr3.1.12.1.2
    text:
      v: Additional enrollees this approval period
    answer:
      value:
        v: 5
  item:
    link id:
      v: cr3.1.12.1.3
    text:
      v: Total
    answer:
      value:
        v: 9
item:
  link id:
    v: cr3.1.12.2
  text:
    v: Not Hispanic or Latino
  item:
    link id:
      v: cr3.1.12.2.1
    text:
      v: Previous Accrual
    answer:
      value:
        v: 4
  item:
    link id:
      v: cr3.1.12.2.2
    text:
      v: Additional enrollees this approval period
    answer:
      value:
        v: 5
  item:
    link id:
      v: cr3.1.12.2.3
    text:
      v: Total
    answer:
      value:
        v: 9
item:
  link id:
    v: cr3.1.12.3
  text:
    v: Unknown/Not Reported
  item:
    link id:
      v: cr3.1.12.3.1
    text:
      v: Previous Accrual
    answer:
      value:
        v: 0
  item:
    link id:
      v: cr3.1.12.3.2
    text:
      v: Additional enrollees this approval period
    answer:
      value:
        v: 0
  item:
    link id:
      v: cr3.1.12.3.3
    text:
      v: Total
    answer:
      value:
        v: 0

link id:
  v: cr3.2
text:
  v: Vulnerable Populations
item:
  link id:
    v: cr3.2.1
  text:
    v: Number of potentially vulnerable participants enrolled
  item:
    link id:
      v: cr3.2.1.1
    text:
      v: Previous Accrual
    answer:
      value:
        v: 0
  item:
    link id:
      v: cr3.2.1.2
    text:
      v: Additional enrollees this approval period
    answer:
      value:
        v: 0
  item:
    link id:
      v: cr3.2.1.3
    text:
      v: Total
    answer:
      value:
        v: 0
item:
  link id:
    v: cr3.2.2
  text:
    v: Check the applicable checkboxes if these groups are represented in the columns above
  item:
    link id:
      v: cr3.2.2.3
    text:
      v: Employees
    answer:
      value: Coding
  item:
    link id:
      v: cr3.2.2.8
    text:
      v: Students
    answer:
      value: Coding

v: AdditionalEnrollees

v: Additional enrollees this approval period

v: PreviousAccrual

v: Previous Accrual

link id:
  v: cr4
text:
  v: Study Report
item:
  link id:
    v: cr4.5
  text:
    v: Since your last report:
  item:
    link id:
      v: cr4.5.1
    text:
      v: Summarize the study progress
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: cr4.5.2
    text:
      v: Have participants experienced any benefits?
    answer:
      value: Coding
  item:
    link id:
      v: cr4.5.3
    text:
      v: If yes, please summarize the benefits:
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: cr4.5.4
    text:
      v: Have participants been withdrawn from this study?
    answer:
      value: Coding
  item:
    link id:
      v: cr4.5.5
    text:
      v: If yes, please summarize the withdrawals:
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: cr4.5.6
    text:
      v: Have any participants or others complained about the research?
    answer:
      value: Coding
  item:
    link id:
      v: cr4.5.7
    text:
      v: If yes, please summarize the complaints:
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: cr4.5.8
    text:
      v: Has any new and relevant literature been published related to the risks or benefits associated with this research?
    answer:
      value: Coding
  item:
    link id:
      v: cr4.5.9
    text:
      v: If yes, please summarize relevance to study:
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: cr4.5.10
    text:
      v: Have there been any interim findings?
    answer:
      value: Coding
  item:
    link id:
      v: cr4.5.11
    text:
      v: If yes, please summarize findings:
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: cr4.5.12
    text:
      v: Have there been any multi-center trial reports?
    answer:
      value: Coding
  item:
    link id:
      v: cr4.5.13
    text:
      v: If yes, please summarize findings and recommendations
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: cr4.5.14
    text:
      v: Have there been any data safety monitoring board reports?
    answer:
      value: Coding
  item:
    link id:
      v: cr4.5.15
    text:
      v: If yes, please summarize findings and recommendations:
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: cr4.5.16
    text:
      v: In the opinion of the Principal Investigator, have the risks or potential benefits changed?
    answer:
      value: Coding
  item:
    link id:
      v: cr4.5.17
    text:
      v: If yes, please summarize the changes:
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: cr4.5.18
    text:
      v: Has an audit of the research been conducted by a federal agency or sponsor?
    answer:
      value: Coding
  item:
    link id:
      v: cr4.5.19
    text:
      v: Have there been any presentations or publications (including abstracts) from this research?
    answer:
      value: Coding
  item:
    link id:
      v: cr4.5.20
    text:
      v: Have there been any substantial changes to the study (protocol, consent forms, or other study documents) or to the risk-benefit assessment?
    answer:
      value: Coding
  item:
    link id:
      v: cr4.5.21
    text:
      v: If yes, please summarize the changes:
    answer:
      value:
        v: [answer]
  item:
    link id:
      v: cr4.5.22
    text:
      v: Was informed consent obtained from all enrolled participants?
    answer:
      value: Coding
  item:
    link id:
      v: cr4.5.23
    text:
      v: Has there been any other relevant information regarding this protocol?
    answer:
      value: Coding
  item:
    link id:
      v: cr4.5.24
    text:
      v: If yes, please summarize:
    answer:
      value:
        v: [answer]

v: Y

v: Yes

v: Y

v: Yes

v: Y

v: Yes

v: Y

v: Yes

v: Y

v: Yes

v: Y

v: Yes

v: Y

v: Yes

v: Y

v: Yes

v: Y

v: Yes

v: Y

v: Yes

v: Y

v: Yes

v: N

v: No

v: Y

v: Yes

link id:
  v: cr5
text:
  v: Adverse Events
item:
  link id:
    v: cr5.1
  text:
    v: Have there been any internal or local adverse events in the research?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: cr5.2
  text:
    v: Did these adverse events occur at the frequency and level of severity expected?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: cr5.3
  text:
    v: Have any protocol deviations or violations occurred 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: cr5.13
  text:
    v: If yes, please describe the protocol deviations or violations
  answer:
    value:
      v: [answer]

link id:
  v: cr6
text:
  v: Conflict of Interest
item:
  link id:
    v: cr6.1
  text:
    v: Has there been a change in the financial disclosure status of the Principal Investigator or other members of the Research Staff that has not been reported to the IRB?
  answer:
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0532
      code:
        v: Y
      display:
        v: Yes
item:
  link id:
    v: cr6.2
  text:
    v: If yes, please explain:
  answer:
    value:
      v: [answer]

link id:
  v: cr17
text:
  v: Attachments
item:
  link id:
    v: cr17.2
  text:
    v: Attachment
  answer:
    value: Attachment
      content type:
        v: application/vnd.openxmlformats-officedocument.wordprocessingml.document
      title:
        v: Example attachment.docx
      creation:
        v: 2022-02-27T22:24:16.963Z

link id:
  v: ADMIN00
text:
  v: Administrative Use Only
item:
  link id:
    v: ADMIN01
  text:
    v: Link ID prefix
  answer:
    value:
      v: cr
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, if any
  answer:
    value:
      v: ResearchStudyExample-sIRB