FHIR IG analytics| Package | hl7.fhir.us.sirb |
| Resource Type | QuestionnaireResponse |
| Id | QuestionnaireResponse-continuing-review-populate-exampleQR.json |
| FHIR Version | R4 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
| LinkId | Text | Definition | Answer |
|---|---|---|---|
  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 | 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 | |
| cr3.1.5.3 | Total | 0 | |
| cr3.1.6 | Participants lost to contact | ||
| cr3.1.6.1 | Previous Accrual | 0 | |
| cr3.1.6.2 | Additional enrollees this approval period | 0 | |
| cr3.1.6.3 | Total | 0 | |
| cr3.1.7 | Participants with screen failures | ||
| cr3.1.7.1 | Previous Accrual | 0 | |
| cr3.1.7.2 | Additional enrollees this approval period | 0 | |
| cr3.1.7.3 | Total | 0 | |
| cr3.1.8 | Participants still active or follow-up | ||
| cr3.1.8.1 | Previous Accrual | 10 | |
| cr3.1.8.2 | Additional enrollees this approval period | 10 | |
| cr3.1.8.3 | Total | 20 | |
| cr3.1.9 | Participants completed study | ||
| cr3.1.9.1 | Previous Accrual | 5 | |
| cr3.1.9.2 | Additional enrollees this approval period | 0 | |
| cr3.1.9.3 | Total | 5 | |
| cr3.1.10 | By Sex | ||
| cr3.1.10.1 | Men | ||
| cr3.1.10.1.1 | Previous Accrual | 6 | |
| cr3.1.10.1.2 | Additional enrollees this approval period | 5 | |
| cr3.1.10.1.3 | Total | 11 | |
| cr3.1.10.2 | Women | ||
 cr3.1.10.2.1 | Previous Accrual | 4 | |
| cr3.1.10.2.2 | Additional enrollees this approval period | 15 | |
| cr3.1.10.2.3 | Total | 19 | |
| cr3.1.11 | By Race | ||
| cr3.1.11.1 | White | ||
| cr3.1.11.1.1 | Previous Accrual | 3 | |
| cr3.1.11.1.2 | Additional enrollees this approval period | 3 | |
| cr3.1.11.1.3 | Total | 6 | |
| cr3.1.11.2 | Black or African American | ||
| cr3.1.11.2.1 | Previous Accrual | 3 | |
| cr3.1.11.2.2 | Additional enrollees this approval period | 4 | |
| cr3.1.11.2.3 | Total | 7 | |
| cr3.1.11.3 | Asian | ||
| cr3.1.11.3.1 | Previous Accrual | 2 | |
| cr3.1.11.3.2 | Additional enrollees this approval period | 3 | |
| cr3.1.11.3.3 | Total | 5 | |
| cr3.1.11.4 | American Indian or Alaska Native | ||
| cr3.1.11.4.1 | Previous Accrual | 1 | |
| cr3.1.11.4.2 | Additional enrollees this approval period | 0 | |
| cr3.1.11.4.3 | Total | 1 | |
| cr3.1.11.5 | Native Hawaiian or other Pacific Islander | ||
| cr3.1.11.5.1 | Previous Accrual | 0 | |
| cr3.1.11.5.2 | Additional enrollees this approval period | 1 | |
| cr3.1.11.5.3 | Total | 1 | |
| cr3.1.11.6 | More than One Race | ||
| cr3.1.11.6.1 | Previous Accrual | 2 | |
| cr3.1.11.6.2 | Additional enrollees this approval period | 0 | |
| cr3.1.11.6.3 | Total | 2 | |
| cr3.1.11.7 | Unknown/Not Reported | ||
| cr3.1.11.7.1 | Previous Accrual | 0 | |
| cr3.1.11.7.2 | Additional enrollees this approval period | 0 | |
| cr3.1.11.7.3 | Total | 0 | |
| cr3.1.12 | By Ethnicity | ||
| cr3.1.12.1 | Hispanic or Latino | ||
| cr3.1.12.1.1 | Previous Accrual | 4 | |
| cr3.1.12.1.2 | Additional enrollees this approval period | 5 | |
| cr3.1.12.1.3 | Total | 9 | |
| cr3.1.12.2 | Not Hispanic or Latino | ||
| cr3.1.12.2.1 | Previous Accrual | 4 | |
| cr3.1.12.2.2 | Additional enrollees this approval period | 5 | |
| cr3.1.12.2.3 | Total | 9 | |
| cr3.1.12.3 | Unknown/Not Reported | ||
| cr3.1.12.3.1 | Previous Accrual | 0 | |
| cr3.1.12.3.2 | Additional enrollees this approval period | 0 | |
| cr3.1.12.3.3 | Total | 0 | |
| cr3.2 | Vulnerable Populations | ||
| cr3.2.1 | Number of potentially vulnerable participants enrolled | ||
| cr3.2.1.1 | Previous Accrual | 0 | |
| cr3.2.1.2 | Additional enrollees this approval period | 0 | |
| cr3.2.1.3 | Total | 0 | |
| cr3.2.2 | Check the applicable checkboxes if these groups are represented in the columns above | ||
| cr3.2.2.3 | Employees | Temporary Codes AdditionalEnrollees: Additional enrollees this approval period | |
| cr3.2.2.8 | Students | Temporary Codes PreviousAccrual: Previous Accrual | |
| cr4 | Study Report | ||
| cr4.5 | Since your last report: | ||
| cr4.5.1 | Summarize the study progress | [answer] | |
| cr4.5.2 | Have participants experienced any benefits? | expandedYes-NoIndicator Y: Yes | |
| cr4.5.3 | If yes, please summarize the benefits: | [answer] | |
| cr4.5.4 | Have participants been withdrawn from this study? | expandedYes-NoIndicator Y: Yes | |
| cr4.5.5 | If yes, please summarize the withdrawals: | [answer] | |
| cr4.5.6 | Have any participants or others complained about the research? | expandedYes-NoIndicator Y: Yes | |
| cr4.5.7 | If yes, please summarize the complaints: | [answer] | |
| cr4.5.8 | Has any new and relevant literature been published related to the risks or benefits associated with this research? | expandedYes-NoIndicator Y: Yes | |
| cr4.5.9 | If yes, please summarize relevance to study: | [answer] | |
| cr4.5.10 | Have there been any interim findings? | expandedYes-NoIndicator Y: Yes | |
| cr4.5.11 | If yes, please summarize findings: | [answer] | |
| cr4.5.12 | Have there been any multi-center trial reports? | expandedYes-NoIndicator Y: Yes | |
| cr4.5.13 | If yes, please summarize findings and recommendations | [answer] | |
| cr4.5.14 | Have there been any data safety monitoring board reports? | expandedYes-NoIndicator Y: Yes | |
| cr4.5.15 | If yes, please summarize findings and recommendations: | [answer] | |
| cr4.5.16 | In the opinion of the Principal Investigator, have the risks or potential benefits changed? | expandedYes-NoIndicator Y: Yes | |
| cr4.5.17 | If yes, please summarize the changes: | [answer] | |
| cr4.5.18 | Has an audit of the research been conducted by a federal agency or sponsor? | expandedYes-NoIndicator Y: Yes | |
| cr4.5.19 | Have there been any presentations or publications (including abstracts) from this research? | expandedYes-NoIndicator Y: Yes | |
| cr4.5.20 | Have there been any substantial changes to the study (protocol, consent forms, or other study documents) or to the risk-benefit assessment? | expandedYes-NoIndicator Y: Yes | |
| cr4.5.21 | If yes, please summarize the changes: | [answer] | |
| cr4.5.22 | Was informed consent obtained from all enrolled participants? | expandedYes-NoIndicator N: No | |
| cr4.5.23 | Has there been any other relevant information regarding this protocol? | expandedYes-NoIndicator Y: Yes | |
| cr4.5.24 | If yes, please summarize: | [answer] | |
| cr5 | Adverse Events | ||
| cr5.1 | Have there been any internal or local adverse events in the research? | expandedYes-NoIndicator Y: Yes | |
| cr5.2 | Did these adverse events occur at the frequency and level of severity expected? | expandedYes-NoIndicator Y: Yes | |
| cr5.3 | Have any protocol deviations or violations occurred in this study? | expandedYes-NoIndicator Y: Yes | |
| cr5.13 | If yes, please describe the protocol deviations or violations | [answer] | |
| cr6 | Conflict of Interest | ||
| cr6.1 | 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? | expandedYes-NoIndicator Y: Yes | |
| cr6.2 | If yes, please explain: | [answer] | |
| cr17 | Attachments | ||
| cr17.2 | Attachment | No display for Attachment | |
| ADMIN00 | Administrative Use Only | ||
| ADMIN01 | Link ID prefix | cr | |
| ADMIN02 | Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any | initiate-study-populate-exampleQR | |
| ADMIN03 | ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any | ResearchStudyExample-sIRB | |
| Documentation for this format | |||
FHIR
FHIRsmith{
"resourceType": "QuestionnaireResponse",
"id": "continuing-review-populate-exampleQR",
"meta": {
"versionId": "1",
"lastUpdated": "2022-02-28T01:27:32.888+00:00"
},
"text": {
"status": "generated",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/workflow-researchStudy",
"valueReference": {
"reference": "ResearchStudy/ResearchStudyExample-sIRB",
"display": "ResearchStudyExample-sIRB"
}
}
],
"questionnaire": "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire-populate",
"status": "completed",
"authored": "2022-02-28T01:27:32.100Z",
"item": [
{
"linkId": "cr1",
"text": "Research Study",
"item": [
{
"linkId": "cr1.1",
"text": "Study Title",
"answer": [
{
"valueString": "Study of Drug A for arthritis"
}
]
},
{
"linkId": "cr1.2",
"text": "IRB Protocol Number",
"answer": [
{
"valueString": "PRO098765"
}
]
},
{
"linkId": "cr1.3",
"text": "Enrollment Status",
"answer": [
{
"valueCoding": {
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code": "open",
"display": "Open for enrollment"
}
}
]
},
{
"linkId": "cr1.4",
"text": "Intervention Status",
"answer": [
{
"valueCoding": {
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code": "continue-meds",
"display": "Continuing interventions"
}
}
]
},
{
"linkId": "cr1.5",
"text": "Study Status",
"answer": [
{
"valueCoding": {
"system": "http://hl7.org/fhir/research-study-status",
"code": "active",
"display": "Active"
}
}
]
},
{
"linkId": "cr1.6",
"text": "Funding Source(check all that are applicable)",
"answer": [
{
"valueCoding": {
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code": "federal",
"display": "Federal"
}
}
]
}
]
},
{
"linkId": "cr12",
"text": "sIRB (Reviewing Institution)",
"item": [
{
"linkId": "cr12.1",
"text": "sIRB (Reviewing Institution) Name",
"answer": [
{
"valueString": "X Pharmaceutical Research IRB"
}
]
}
]
},
{
"linkId": "cr9",
"text": "Submission Type",
"item": [
{
"linkId": "cr9.1",
"text": "Is this Continuing Review Form being submitted by the lead PI site on behalf of all of the relying sites?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "ExternalDataFor_cr9.2",
"text": "External Data For linkId cr9.2",
"answer": [
{
"valueString": "Sample University Medical Center | | Jane Doe, MD | Sample City, NC"
},
{
"valueString": "Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA"
},
{
"valueString": "Central Campus Test University | | Maria Smith, PhD | Central, MI"
}
]
}
]
},
{
"linkId": "cr11",
"text": "Site Principal Investigator Institution",
"item": [
{
"linkId": "cr11.1",
"text": "Site Principal Investigator Institution Name",
"answer": [
{
"valueString": "Sample University Medical Center"
}
]
}
]
},
{
"linkId": "cr2",
"text": "Site Principal Investigator",
"item": [
{
"linkId": "cr2.1",
"text": "First Name",
"answer": [
{
"valueString": "Jane"
}
]
},
{
"linkId": "cr2.4",
"text": "Last Name",
"answer": [
{
"valueString": "Doe"
}
]
},
{
"linkId": "cr2.6",
"text": "Degree(s)",
"answer": [
{
"valueString": "MD"
}
]
},
{
"linkId": "cr2.10",
"text": "Site Principal Investigator Department Name or Division",
"answer": [
{
"valueString": "Orthopedics"
}
]
},
{
"linkId": "cr2.2",
"text": "Phone",
"answer": [
{
"valueString": "567-123-1234"
}
]
},
{
"linkId": "cr2.3",
"text": "Email",
"answer": [
{
"valueString": "drjanedoe@sampleuniversity.edu"
}
]
}
]
},
{
"linkId": "cr3",
"text": "Accrual of Participants",
"item": [
{
"linkId": "cr3.1",
"text": "Provide counts for the following",
"item": [
{
"linkId": "cr3.1.1",
"text": "Participants enrolled since activation",
"item": [
{
"linkId": "cr3.1.1.1",
"text": "Previous Accrual",
"answer": [
{
"valueInteger": 10
}
]
},
{
"linkId": "cr3.1.1.2",
"text": "Additional enrollees this approval period",
"answer": [
{
"valueInteger": 20
}
]
},
{
"linkId": "cr3.1.1.3",
"text": "Total",
"answer": [
{
"valueInteger": 30
}
]
}
]
},
{
"linkId": "cr3.1.2",
"text": "Participants enrolled since last approval",
"item": [
{
"linkId": "cr3.1.2.1",
"text": "Previous Accrual",
"answer": [
{
"valueInteger": 10
}
]
},
{
"linkId": "cr3.1.2.2",
"text": "Additional enrollees this approval period",
"answer": [
{
"valueInteger": 10
}
]
},
{
"linkId": "cr3.1.2.3",
"text": "Total",
"answer": [
{
"valueInteger": 20
}
]
}
]
},
{
"linkId": "cr3.1.3",
"text": "Participants approved to enroll",
"item": [
{
"linkId": "cr3.1.3.1",
"text": "Previous Accrual",
"answer": [
{
"valueInteger": 10
}
]
},
{
"linkId": "cr3.1.3.2",
"text": "Additional enrollees this approval period",
"answer": [
{
"valueInteger": 10
}
]
},
{
"linkId": "cr3.1.3.3",
"text": "Total",
"answer": [
{
"valueInteger": 20
}
]
}
]
},
{
"linkId": "cr3.1.4",
"text": "Participants consented",
"item": [
{
"linkId": "cr3.1.4.1",
"text": "Previous Accrual",
"answer": [
{
"valueInteger": 10
}
]
},
{
"linkId": "cr3.1.4.2",
"text": "Additional enrollees this approval period",
"answer": [
{
"valueInteger": 10
}
]
},
{
"linkId": "cr3.1.4.3",
"text": "Total",
"answer": [
{
"valueInteger": 20
}
]
}
]
},
{
"linkId": "cr3.1.5",
"text": "Participants withdrawn",
"item": [
{
"linkId": "cr3.1.5.1",
"text": "Previous Accrual",
"answer": [
{
"valueInteger": 0
}
]
},
{
"linkId": "cr3.1.5.2",
"text": "Additional enrollees this approval period",
"answer": [
{
"valueInteger": 0
}
]
},
{
"linkId": "cr3.1.5.3",
"text": "Total",
"answer": [
{
"valueInteger": 0
}
]
}
]
},
{
"linkId": "cr3.1.6",
"text": "Participants lost to contact",
"item": [
{
"linkId": "cr3.1.6.1",
"text": "Previous Accrual",
"answer": [
{
"valueInteger": 0
}
]
},
{
"linkId": "cr3.1.6.2",
"text": "Additional enrollees this approval period",
"answer": [
{
"valueInteger": 0
}
]
},
{
"linkId": "cr3.1.6.3",
"text": "Total",
"answer": [
{
"valueInteger": 0
}
]
}
]
},
{
"linkId": "cr3.1.7",
"text": "Participants with screen failures",
"item": [
{
"linkId": "cr3.1.7.1",
"text": "Previous Accrual",
"answer": [
{
"valueInteger": 0
}
]
},
{
"linkId": "cr3.1.7.2",
"text": "Additional enrollees this approval period",
"answer": [
{
"valueInteger": 0
}
]
},
{
"linkId": "cr3.1.7.3",
"text": "Total",
"answer": [
{
"valueInteger": 0
}
]
}
]
},
{
"linkId": "cr3.1.8",
"text": "Participants still active or follow-up",
"item": [
{
"linkId": "cr3.1.8.1",
"text": "Previous Accrual",
"answer": [
{
"valueInteger": 10
}
]
},
{
"linkId": "cr3.1.8.2",
"text": "Additional enrollees this approval period",
"answer": [
{
"valueInteger": 10
}
]
},
{
"linkId": "cr3.1.8.3",
"text": "Total",
"answer": [
{
"valueInteger": 20
}
]
}
]
},
{
"linkId": "cr3.1.9",
"text": "Participants completed study",
"item": [
{
"linkId": "cr3.1.9.1",
"text": "Previous Accrual",
"answer": [
{
"valueInteger": 5
}
]
},
{
"linkId": "cr3.1.9.2",
"text": "Additional enrollees this approval period",
"answer": [
{
"valueInteger": 0
}
]
},
{
"linkId": "cr3.1.9.3",
"text": "Total",
"answer": [
{
"valueInteger": 5
}
]
}
]
},
{
"linkId": "cr3.1.10",
"text": "By Sex",
"item": [
{
"linkId": "cr3.1.10.1",
"text": "Men",
"item": [
{
"linkId": "cr3.1.10.1.1",
"text": "Previous Accrual",
"answer": [
{
"valueInteger": 6
}
]
},
{
"linkId": "cr3.1.10.1.2",
"text": "Additional enrollees this approval period",
"answer": [
{
"valueInteger": 5
}
]
},
{
"linkId": "cr3.1.10.1.3",
"text": "Total",
"answer": [
{
"valueInteger": 11
}
]
}
]
},
{
"linkId": "cr3.1.10.2",
"text": "Women",
"item": [
{
"linkId": "cr3.1.10.2.1",
"text": "Previous Accrual",
"answer": [
{
"valueInteger": 4
}
]
},
{
"linkId": "cr3.1.10.2.2",
"text": "Additional enrollees this approval period",
"answer": [
{
"valueInteger": 15
}
]
},
{
"linkId": "cr3.1.10.2.3",
"text": "Total",
"answer": [
{
"valueInteger": 19
}
]
}
]
}
]
},
{
"linkId": "cr3.1.11",
"text": "By Race",
"item": [
{
"linkId": "cr3.1.11.1",
"text": "White",
"item": [
{
"linkId": "cr3.1.11.1.1",
"text": "Previous Accrual",
"answer": [
{
"valueInteger": 3
}
]
},
{
"linkId": "cr3.1.11.1.2",
"text": "Additional enrollees this approval period",
"answer": [
{
"valueInteger": 3
}
]
},
{
"linkId": "cr3.1.11.1.3",
"text": "Total",
"answer": [
{
"valueInteger": 6
}
]
}
]
},
{
"linkId": "cr3.1.11.2",
"text": "Black or African American",
"item": [
{
"linkId": "cr3.1.11.2.1",
"text": "Previous Accrual",
"answer": [
{
"valueInteger": 3
}
]
},
{
"linkId": "cr3.1.11.2.2",
"text": "Additional enrollees this approval period",
"answer": [
{
"valueInteger": 4
}
]
},
{
"linkId": "cr3.1.11.2.3",
"text": "Total",
"answer": [
{
"valueInteger": 7
}
]
}
]
},
{
"linkId": "cr3.1.11.3",
"text": "Asian",
"item": [
{
"linkId": "cr3.1.11.3.1",
"text": "Previous Accrual",
"answer": [
{
"valueInteger": 2
}
]
},
{
"linkId": "cr3.1.11.3.2",
"text": "Additional enrollees this approval period",
"answer": [
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{
"linkId": "cr3.1.11.3.3",
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]
}
]
},
{
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},
{
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}
]
},
{
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},
{
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"text": "Total",
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{
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}
]
}
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}
]
},
{
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"text": "By Ethnicity",
"item": [
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"item": [
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},
{
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"text": "Additional enrollees this approval period",
"answer": [
{
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]
},
{
"linkId": "cr3.1.12.1.3",
"text": "Total",
"answer": [
{
"valueInteger": 9
}
]
}
]
},
{
"linkId": "cr3.1.12.2",
"text": "Not Hispanic or Latino",
"item": [
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{
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},
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"answer": [
{
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}
]
},
{
"linkId": "cr3.1.12.2.3",
"text": "Total",
"answer": [
{
"valueInteger": 9
}
]
}
]
},
{
"linkId": "cr3.1.12.3",
"text": "Unknown/Not Reported",
"item": [
{
"linkId": "cr3.1.12.3.1",
"text": "Previous Accrual",
"answer": [
{
"valueInteger": 0
}
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},
{
"linkId": "cr3.1.12.3.2",
"text": "Additional enrollees this approval period",
"answer": [
{
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}
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},
{
"linkId": "cr3.1.12.3.3",
"text": "Total",
"answer": [
{
"valueInteger": 0
}
]
}
]
}
]
}
]
},
{
"linkId": "cr3.2",
"text": "Vulnerable Populations",
"item": [
{
"linkId": "cr3.2.1",
"text": "Number of potentially vulnerable participants enrolled",
"item": [
{
"linkId": "cr3.2.1.1",
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"answer": [
{
"valueInteger": 0
}
]
},
{
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"text": "Additional enrollees this approval period",
"answer": [
{
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}
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},
{
"linkId": "cr3.2.1.3",
"text": "Total",
"answer": [
{
"valueInteger": 0
}
]
}
]
},
{
"linkId": "cr3.2.2",
"text": "Check the applicable checkboxes if these groups are represented in the columns above",
"item": [
{
"linkId": "cr3.2.2.3",
"text": "Employees",
"answer": [
{
"valueCoding": {
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code": "AdditionalEnrollees",
"display": "Additional enrollees this approval period"
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}
]
},
{
"linkId": "cr3.2.2.8",
"text": "Students",
"answer": [
{
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"display": "Previous Accrual"
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}
]
}
]
},
{
"linkId": "cr4",
"text": "Study Report",
"item": [
{
"linkId": "cr4.5",
"text": "Since your last report:",
"item": [
{
"linkId": "cr4.5.1",
"text": "Summarize the study progress",
"answer": [
{
"valueString": "[answer]"
}
]
},
{
"linkId": "cr4.5.2",
"text": "Have participants experienced any benefits?",
"answer": [
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"display": "Yes"
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},
{
"linkId": "cr4.5.3",
"text": "If yes, please summarize the benefits:",
"answer": [
{
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},
{
"linkId": "cr4.5.4",
"text": "Have participants been withdrawn from this study?",
"answer": [
{
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"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
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},
{
"linkId": "cr4.5.5",
"text": "If yes, please summarize the withdrawals:",
"answer": [
{
"valueString": "[answer]"
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]
},
{
"linkId": "cr4.5.6",
"text": "Have any participants or others complained about the research?",
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"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
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{
"linkId": "cr4.5.7",
"text": "If yes, please summarize the complaints:",
"answer": [
{
"valueString": "[answer]"
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},
{
"linkId": "cr4.5.8",
"text": "Has any new and relevant literature been published related to the risks or benefits associated with this research?",
"answer": [
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"code": "Y",
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},
{
"linkId": "cr4.5.9",
"text": "If yes, please summarize relevance to study:",
"answer": [
{
"valueString": "[answer]"
}
]
},
{
"linkId": "cr4.5.10",
"text": "Have there been any interim findings?",
"answer": [
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"code": "Y",
"display": "Yes"
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}
]
},
{
"linkId": "cr4.5.11",
"text": "If yes, please summarize findings:",
"answer": [
{
"valueString": "[answer]"
}
]
},
{
"linkId": "cr4.5.12",
"text": "Have there been any multi-center trial reports?",
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"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
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}
]
},
{
"linkId": "cr4.5.13",
"text": "If yes, please summarize findings and recommendations",
"answer": [
{
"valueString": "[answer]"
}
]
},
{
"linkId": "cr4.5.14",
"text": "Have there been any data safety monitoring board reports?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
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}
]
},
{
"linkId": "cr4.5.15",
"text": "If yes, please summarize findings and recommendations:",
"answer": [
{
"valueString": "[answer]"
}
]
},
{
"linkId": "cr4.5.16",
"text": "In the opinion of the Principal Investigator, have the risks or potential benefits changed?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "cr4.5.17",
"text": "If yes, please summarize the changes:",
"answer": [
{
"valueString": "[answer]"
}
]
},
{
"linkId": "cr4.5.18",
"text": "Has an audit of the research been conducted by a federal agency or sponsor?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "cr4.5.19",
"text": "Have there been any presentations or publications (including abstracts) from this research?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "cr4.5.20",
"text": "Have there been any substantial changes to the study (protocol, consent forms, or other study documents) or to the risk-benefit assessment?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "cr4.5.21",
"text": "If yes, please summarize the changes:",
"answer": [
{
"valueString": "[answer]"
}
]
},
{
"linkId": "cr4.5.22",
"text": "Was informed consent obtained from all enrolled participants?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "N",
"display": "No"
}
}
]
},
{
"linkId": "cr4.5.23",
"text": "Has there been any other relevant information regarding this protocol?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "cr4.5.24",
"text": "If yes, please summarize:",
"answer": [
{
"valueString": "[answer]"
}
]
}
]
}
]
},
{
"linkId": "cr5",
"text": "Adverse Events",
"item": [
{
"linkId": "cr5.1",
"text": "Have there been any internal or local adverse events in the research?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "cr5.2",
"text": "Did these adverse events occur at the frequency and level of severity expected?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "cr5.3",
"text": "Have any protocol deviations or violations occurred in this study?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "cr5.13",
"text": "If yes, please describe the protocol deviations or violations",
"answer": [
{
"valueString": "[answer]"
}
]
}
]
},
{
"linkId": "cr6",
"text": "Conflict of Interest",
"item": [
{
"linkId": "cr6.1",
"text": "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": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "cr6.2",
"text": "If yes, please explain:",
"answer": [
{
"valueString": "[answer]"
}
]
}
]
},
{
"linkId": "cr17",
"text": "Attachments",
"item": [
{
"linkId": "cr17.2",
"text": "Attachment",
"answer": [
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"title": "Example attachment.docx",
"creation": "2022-02-27T22:24:16.963Z"
}
}
]
}
]
},
{
"linkId": "ADMIN00",
"text": "Administrative Use Only",
"item": [
{
"linkId": "ADMIN01",
"text": "Link ID prefix",
"answer": [
{
"valueString": "cr"
}
]
},
{
"linkId": "ADMIN02",
"text": "Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any",
"answer": [
{
"valueString": "initiate-study-populate-exampleQR"
}
]
},
{
"linkId": "ADMIN03",
"text": "ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any",
"answer": [
{
"valueString": "ResearchStudyExample-sIRB"
}
]
}
]
}
]
}