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IG for Utilizing a Digital Protocol for Clinical Trials (Jira PSS-2526)

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Basics

IG for Utilizing a Digital Protocol for Clinical Trials (Jira PSS-2526)

1925
Ballot - STU




Details

An initial use looked at a simple document based transfer and was tested at the May 2024 connectathon. The September 2024 connectathon tested representation of protocol meta data. This initial work has provided sufficient groundwork to begin building a draft IG. The underlying ICH/CDISC/TransCelerate standards are scheduled for final publication in 2025 and the overall project objective is to provide an appropriate FHIR IG on a similar timescale.


There is work ongoing within the ICH (M11/M2 CeSHarP), and also CDISC and TransCelerate (USDM) to provide a comprehensive digital representation of Clinical Trial protocols. Providing a FHIR representation of this digital protocol will maximise the opportunities for interoperability between Clinical Trial design and execution and Patient care as represented in (for example) EHRs and Care Plans.

There are many potential use cases, for instance:

- Sponsor to Regulator Protocol Transmission (ICH)

- SoA for a Subject (update existing IG) (Vulcan)

- Version management (e.g, difference simplification and participant correlations)

- Study estimated cost analysis

- Site-level qualifications (e.g., specialty, medical resources, etc.)

- Cohort identification / Eligibility / Capability

- Study feasibility (e.g., running SoA on sample data)

- Using a digital protocol as a single source of truth

- Harmonising Definitions of Terminology and Process

- Structured Data Capture derived from Protocol Definitions

Rather than create separate projects and IGs for each use case the proposed project will act as an umbrella for all the work and a multi-part IG will be developed to cover all of the use cases.



FHIR IG - R1 - STU - Target: 2025 September Ballot Cycle


tbd


ICH M11 CeSHarP & CDISC USDM - producing a technical IG of these standards that ICH and CDISC are producing.

Other (specify in Misc. Notes below),N/A

CDISC TransCelerate Computable Publishing LLC

A digital protocol enables more efficient conduct of clinical research. With easier and cheaper clinical research comes greater access for a more diverse subject population which in turn enables better quality research. A digital protocol is also much easier to integrate with other care systems such as EHRs.

UDP


N/A

N/A


Stakeholders: Academic/Research, Healthcare IT Vendors, Pharmaceutical/Biotech, Regulatory Agency, Standards Development Organizations (SDOs), Vendor/Manufacturer
Organization & Realm

Universal

People

Hugh Glover



Biomedical Research and Regulation Work Group

Clinical Decision Support Work Group

Status & Dates

Active

STU - Reconcile

01/27/2025

09/01/2028

2028 Sept WGM/Ballot

05/15/2028

2028 May WGM/Ballot

2026 May ballot cycle info: STU Ballot results: Met basic vote requirements. 3 negatives to reconcile. Document Name: HL7 FHIR® Implementation Guide: Clinical Study Protocol, Edition 1 2025 Sep Ballot cycle Info: STU Ballot Results: Met basic vote requirements. 2 negatives to reconcile Document Name: HL7 FHIR® Implementation Guide: Pharmaceutical Clinical Trial Protocols, Edition 1
Approvals

04/07/2025


Not Needed


All Received




FHIR Management Group -- Agreed -- (PSS-2563)
System Info

247939

PSS-2526

https://jira.hl7.org/browse/PSS-2526
View Ballot Items (with NIBs)



06/25/2026

Anne Wizauer
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