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Note that the sIRB team will be convening Friday, May 15 at 9AM ET to provide test scripts and setup.


Submitting WG/Project/Implementer Group

Biomedical Research and Regulation /sIRB

Justification and Objectives

For this track, we plan to have participants step through the generalized workflow of the sIRB process including use of a standardized form, collection of data, and transmission and retrieval of these data using FHIR standards to simulate the sharing of data between reviewing and relying IRB vendor software. 

This track will use R4 version of FHIR.

Clinical input requested (if any)

No specific clinical input is requested, although we are open to feedback on the content of the forms as well as the technical infrastructure.

Related tracks

(used to help guide seating arrangements and possibly drive track consolidation)

Proposed Track Lead

James Topping, Duke University james.topping@duke.edu

Expected participants

We currently expect 2 academic members and possibly 1 or 2 representatives from the IRB vendor community.   

System Roles

System Role 1: A server containing the proposed forms will be provided. 

System Role 2: The NLM LHC Forms website will be available for form completion.  This role could also be fulfilled in the future using IRB vendor software.

System Role 3:  A test FHIR server for saving and retrieval of data will be provided.

Role 1 Name

Scenarios

Participants will asked to replicate a standard scenario where a PI retrieves a standard form (there will be multiple), completes it based on supporting documents and the needs of their project (as would occur at the reviewing IRB) and transmits it using FHIR standards to a FHIR server.  This form will then be retrieved and rendered (as would occur at the relying IRB). 

Scenario Step 1 Name

Action: Retrieval of forms, Completion and Submission using FHIR standards, retrieval and rendering.

Precondition: Provided forms, provided test server.

Success Criteria: Successful completion of the full pathway from blank forms to retrieved data.

Bonus point:

TestScript(s)

Indicate any test scripts that will be used to help verify system behavior

Security and Privacy Considerations

Identify any expectations around security (e.g. will TLS, mutual-TLS, OAuth, etc. be required to participate

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