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

Conformance and Functionality Expectations

The conformance and functionality expectations of each type of actor is listed below. In general, the sIRB will be the institution hosting the sIRB FHIR server that stores the Questionnaires and the QuestionnaireResponses. The host institution will also host a website or other sIRB software to render the blank forms and display the completed questionnaire responses for edits, review or saving to pdf.

The exchange framework used is the “RESTful FHIR”.

Host of the FHIR server (generally the sIRB) FHIR server compliant with FHIR 4.0 and SDC Questionnaire: SHALL support search by url, version and/or status.
MAY also support search by _lastUpdated

QuestionnaireResponse: SHALL support create and update with version-checking.
SHALL also support search by questionnaire, author and _lastUpdated.
MAY support patch

ResearchStudy: MAY support create and update with version-checking.
MAY also support search by identifier

FHIR Questionnaire Management Software (could be the host institution’s research study system, another type of software or the sIRB on FHIR software)

Questionnaire: SHALL support search by url, version and/or status. MAY also support search by _lastUpdated QuestionnaireResponse: SHALL support create and update with version-checking. SHALL also support search by questionnaire, author and _lastUpdated. MAY support patch ResearchStudy: MAY support create and update with version-checking. MAY also support search by identifier

Non-host (generally the relying sites) If the non-host wishes to interact with the forms without the requirement of having a FHIR server, then the host institution must provide software or a website with the software for viewing, completing and storing the forms on the host institution’s FHIR server that can be accessed via a web browser If the non-host wish to use a FHIR server, then the FHIR server should have the capabilities defined in the “Host of the FHIR server (generally the sIRB)” section.