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FHIR Accelerator Announces Digitized Clinical Research Protocol Project
The Vulcan FHIR Accelerator will connect CDISC, HL7, and ICH M11 in a project to digitize the exchange of clinical research protocols.
HL7 FHIR Accelerator Vulcan and standards development organization CDISC have announced a project to deliver an electronic exchange standard for the ICH M11 Clinical electronic Structured Harmonised Protocol (CeSHarP) to advance clinical research.
“The project marks an important milestone in the long journey towards a digital protocol,” Amy Cramer, Vulcan co-chair, said in a press release. “Over the years, various organizations have contributed key building blocks. Vulcan is pleased to serve as a convener where contributors across the global research community can collaborate towards this shared and important goal.”
A FHIR-based data exchange standard for ICH’s CeSHarP, aligned to CDISC standards, is set to boost value across the clinical trials ecosystem.
ICH M11 is creating a clinical protocol template, guideline, and technical specification to serve as the project’s foundation.
“We are looking forward to partnering with ICH M11 and HL7 on this important project that aims to enable the digital transformation of protocols in support of automation,” said David Evans, president and CEO of CDISC. “This project represents another step in CDISC’s strategic evolution to embrace governance of clinical research information standards, not just clinical data standards.”
CDISC’s Unified Study Definition Model (USDM), co-developed with TransCelerate BioPharma, will be leveraged to accelerate content model development. Additional inputs will include CDISC Controlled Terminology and Vulcan FHIR Implementation Guides.
The organizations will execute the project within the HL7 Vulcan Project Framework supplemented by a Joint Leadership Forum to foster alignment among CDISC, ICH M11, and HL7 Vulcan.
The project is now in the discovery and scoping phase. Full kick-off is anticipated for summer 2023.