The Vulcan FHIR Accelerator, in collaboration with CDISC and HL7, has announced a project aimed at digitizing the exchange of clinical research protocols. This initiative will develop an electronic exchange standard for the ICH M11 Clinical electronic Structured Harmonised Protocol (CeSHarP) to advance clinical research. The goal is to create a FHIR-based data exchange standard aligned with CDISC standards, which will bring significant value to the clinical trials ecosystem. CDISC's Unified Study Definition Model (USDM) and other resources will be utilized to expedite content model development. The project is currently in the discovery and scoping phase, with a full kick-off expected in summer 2023.
This project is a significant milestone in the journey towards digitizing clinical research protocols. By bringing together various organizations and stakeholders from the global research community, Vulcan aims to serve as a convener for collaboration towards this shared objective. The development of a FHIR-based data exchange standard for ICH's CeSHarP, in alignment with CDISC standards, holds the potential to enable automation and support the digital transformation of protocols. CDISC's expertise in clinical research information standards, along with inputs from Vulcan and HL7, will contribute to the successful implementation of this project.
To facilitate the project's execution, the HL7 Vulcan Project Framework will be utilized, along with a Joint Leadership Forum to foster alignment among CDISC, ICH M11, and HL7 Vulcan. The scoping and discovery phase is currently underway, and a full kick-off is anticipated for summer 2023. This project represents a crucial step in embracing the governance of clinical research information standards and signifies the commitment of the organizations involved to drive innovation and efficiency in clinical research protocols.
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