Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot

This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

Example QuestionnaireResponse: Initiate a Study Questionnaire Response

Generated Narrative

questionnaire: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire

status: completed

authored: Jul 23, 2021 5:52:41 AM

item

linkId: in1

text: Research Study Details

item

linkId: in1.1

text: Study Title

item

linkId: in1.2

text: Study Title (Short)

item

linkId: in1.3

text: IRB Protocol Number

item

linkId: in1.4

text: Study Type

item

linkId: in5

text: Other Organization(s) Involved

item

linkId: in5.1

text: Relationship Type

item

linkId: in5.2

text: Organization Name

item

linkId: in5.3

text: Phone

item

linkId: in5.4

text: Sponsor or Funding Source Protocol Number, if applicable

item

linkId: in5

text: Other Organization(s) Involved

item

linkId: in5.1

text: Relationship Type

item

linkId: in5.2

text: Organization Name

item

linkId: in5.3

text: Phone

item

linkId: in5

text: Other Organization(s) Involved

item

linkId: in5.1

text: Relationship Type

item

linkId: in5.2

text: Organization Name

item

linkId: in5.3

text: Phone

item

linkId: in6

text: sIRB (Reviewing Institution)

item

linkId: in6.1

text: sIRB (Reviewing Institution) Name

item

linkId: in6.3

text: Institution Street Address

item

linkId: in6.4

text: Institution City

item

linkId: in6.5

text: Institution State

item

linkId: in6.6

text: Institution Zip Code

item

linkId: in6.7

text: Institution Country

item

linkId: in6.8

text: Is a Federal Wide Assurance (FWA) Number assigned?

item

linkId: in6.9

text: Federal Wide Assurance Number (if assigned)

item

linkId: in7

text: Overall Principal Investigator for the Study

item

linkId: in7.1

text: Overall Principal Investigator First Name

item

linkId: in7.2

text: Overall Principal Investigator Last Name

item

linkId: in7.3

text: Overall Principal Investigator Suffix

item

linkId: in7.4

text: Academic and Professional Degrees associated with the Overall Principal Investigator

item

linkId: in7.5

text: Overall Principal Investigator Institution Name

item

linkId: in7.6

text: Department Name or Division

item

linkId: in7.7

text: Street Address

item

linkId: in7.8

text: City

item

linkId: in7.9

text: State

item

linkId: in7.10

text: Zip Code

item

linkId: in7.11

text: Country

item

linkId: in7.12

text: Overall Principal Investigator Phone

item

linkId: in7.13

text: Overall Principal Investigator Email Address

item

linkId: in8

text: Confirmed or Potential Relying Site(s)

item

linkId: in8.1

text: Confirmed or Potential Relying Site Overview

item

linkId: in8.3

text: Site Principal Investigator at Relying Site

item

linkId: in8

text: Confirmed or Potential Relying Site(s)

item

linkId: in8.1

text: Confirmed or Potential Relying Site Overview

item

linkId: in8.3

text: Site Principal Investigator at Relying Site

item

linkId: in9

text: Questionnaire Version Details

item

linkId: in9.1

text: Questionnaire Version

item

linkId: in9.2

text: Questionnaire Version Date

item

linkId: ADMIN00

text: Administrative Use Only (will be hidden in the future)

item

linkId: ADMIN01

text: Link ID prefix

item

linkId: ADMIN02

text: Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any

item

linkId: ADMIN03

text: ID of the Research Study FHIR Resource associated with the study Questionnaire Responses