The Vulcan FHIR Accelerator, in collaboration with CDISC and HL7, has announced a project to digitize clinical research protocols. To promote clinical research, the program aims to create an FHIR-based data interchange standard that is compliant with CDISC requirements. The ICH M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP) will serve as the project’s framework. The project will make use of the Vulcan FHIR Implementation Guidelines and CDISC’s Unified Study Definition Model (USDM), and it is anticipated to begin in the summer of 2023.
The Vulcan FHIR Accelerator has recently unveiled an initiative aimed at digitizing the exchange of clinical research protocols by connecting CDISC, HL7, and ICH M11. This collaborative project seeks to develop an electronic exchange standard, known as the Clinical Electronic Structured Harmonised Protocol (CeSHarP), to facilitate advancements in clinical research.
Amy Cramer, the co-chair of Vulcan, expressed the significance of this project, stating, “The project represents a major milestone in the ongoing pursuit of a digital protocol. Throughout the years, various organizations have contributed essential elements, and Vulcan is proud to serve as a facilitator where contributors from the global research community can collaborate towards this shared and vital objective.”
The implementation of an FHIR-based data exchange standard, aligned with CDISC standards, holds great potential for enhancing the value within the clinical trials ecosystem. The ICH M11, which is responsible for creating a clinical protocol template, guideline, and technical specification, will provide the foundation for this endeavor.
David Evans, President and CEO of CDISC, expressed enthusiasm for the project, stating, “We are excited to partner with ICH M11 and HL7 on this significant undertaking that aims to enable the digital transformation of protocols in support of automation. This project represents another step in CDISC’s strategic evolution to assume governance of clinical research information standards, not just clinical data standards.”
To expedite the development of the content model, CDISC’s Unified Study Definition Model (USDM), co-developed with TransCelerate BioPharma, will be leveraged. Furthermore, CDISC Controlled Terminology and Vulcan FHIR Implementation Guides will contribute additional insights.
The project will be carried out within the HL7 Vulcan Project Framework, complemented by a Joint Leadership Forum to foster alignment among CDISC, ICH M11, and HL7 Vulcan.
Currently, the project is in the discovery and scoping phase, with the full kick-off anticipated for the summer of 2023.