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Introduction

This Implementation Guide has been developed by the Vulcan UDP Project (Utilizing the Digital Protocol).

The content is based on FHIR R6. This is to take advantage of new features in the ResearchStudy resource. There will be backports to earlier FHIR releases in future.

What is a clinical trial protocol? Conduct of clinical trials is guided by the International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP) E6 which specify the protocol incorporates all aspects of what is needed to define how the study is to be conducted and reviewed. The protocol should provide background and rationale for the study, highlight the specific research questions to be addressed, and take into consideration ethical issues. It describes the objectives, design, methodology, statistical considerations and other aspects related to the organization of the clinical trial.

Who can benefit from utilizing a digital protocol? Users of protocols exist across the full continuum of clinical and translational research and clinical care. Traditional research conducted by the biopharmaceutical industry involves complex processes with innumerous opportunities for automation(See Use Case Opportunities, Present and Future).

Why FHIR? FHIR adoption in healthcare has expanded rapidly in recent years. (See The State of FHIR in 2025). FHIR-based exchange of protocols will enable their use within healthcare systems, helping to bridge clinical research and care and to facilitate translational research. Emerging applications of FHIR in regulated clinical research include exchange of electronic Product Information and PQ-CMC documentation. Leveraging FHIR for protocol exchange enables regulators and sponsors to reuse infrastructure across content types, improving efficiency and consistency. As an open, web-based interoperability standard, FHIR supports exchange of both structured and unstructured data exchange without proprietary limitations and is backed by a global community. Finally, FHIR will enable innovating on innovative automated exchange of ICH M11.

Why ICH M11? It reflects a consensus-driven effort led by global regulatory authorities and industry experts to standardize clinical trial protocols. Regulatory agencies have played a central role in shaping both the protocol template and related specifications, ensuring alignment with their expectations for structured, electronic submissions. As a result, ICH M11 is expected to be incorporated into regulatory guidelines, making its adoption a strong driver for global harmonization and a likely requirement for future protocol submissions. In addition, it is aligned to USDM which is further into the implementation phase.

Why USDM? The Unified Study Definition Model provides a standardized, highly detailed model for articulating protocol and related study information in a machine-readable manner. It incorporates all structured elements of ICH M11 and additional elements (e.g., information used for clinical trial execution, reporting, etc.). USDM development was strongly guided by sponsor subject matter experts and shaped through public standards-setting processes. It is now being adopted by numerous biopharmaceutical companies across a range of sponsor-driven use cases.

Why Vulcan? The Vulcan HL7 FHIR Accelerator aims to bridge research and clinical care through the use of FHIR, strategically connecting collaborators to maximize expertise and efforts. Vulcan members include implementers, sponsors, academic research, government representatives who are working on or have interests in protocol digitization. The Vulcan Utilizing the Digital Protocol (UDP) is an umbrella project integrating related work being developed by ICH M11, CDISC, and TransCelerate to enable compatible, standards-based exchange of ICH M11-aligned clinical trial protocols across research stakeholders including sponsors, sites and regulators.

For additional information on integration of the various efforts and history, please see the "Background" section in this Implementation Guide under "Home" section of the banner and in the "Links" section under the "Support" section of the banner.

Technical Overview

This guide describes the representation of a Protocol in FHIR format. The "document" focus of protocol organization is provided by the ICH M11 CeSHarP Template and Technical Guide. A more structured approach aligned to M11 is addressed by USDM, developed by CDISC in partnership with TransCelerate as part of Digital Data Flow initiative. Both M11 and USDM are represented in the FHIR Representation mapping spreadsheet (found under Downloads section of the banner). This initial version of the IG is focused on on the M11 "document" approach; future versions are intended to expand integration of USDM and FHIR in order to enable exchange of additional structured protocol content in FHIR-based systems.

The key FHIR resources used are ResearchStudy and Composition, while also drawing on some profiles and extensions from the EBM IG. EBM utilizes protocol elements to be able to review and reporting on research completed; UDP will include ICH M11 related items.

For more description of the relationship between the resources, extensions and profiles see the FHIR Representation section and the actual specifications in the Artifacts section.

Core Objectives

The Vulcan UDP project enables digital protocol exchange through FHIR, supporting Vulcan's mission to connect clinical and translational research to clinical care. The main goal of this FHIR Implementation Guide is to developed iteratively concentrating first on near-term achievable use cases to ensure immediate impact and feasibility, while building foundations for, and avoiding blockers to, long-term use cases. The overarching vision is for compatibility across clinical research stakeholders.

The future Governance processes must ensure retaining alignment with ICH M11 and compatible standards of CDISC USDM and Controlled Terminology as well as related uses of FHIR such as those in the Evidence Based Medicine (EBM) Implementation Guide. Successful governance will require active participation in HL7 processes to ensure long-term alignment with related efforts such as EBM, and with other organizations, such as ICH M11, CDISC, and TransCelerate.

Scope

In Scope

The initial use case addressed within this version is FHIR-based exchange of M11-aligned protocols between sponsors and regulators, as driven by ICH M11(Clinical electronic Structured Harmonized Protocols, or CeSHarP). Development was approached to 1) leverage and enable compatibility with related standards where possible and 2) in such a way as to accommodate future use cases. For example, work to align with CDISC USDM is ongoing and viewed as a near-term pathway to expanding delivered use cases.

Out of scope

• Support for any non-ICH M11 aligned protocol exchange in this IG version. The future aim is to develop a use case roadmap, consider the broad spectrum of potential use cases of digital protocols and identify opportunities to establish foundational connections. (See also the Use Cases and Workflows section for some discussion on this).
• Detailed governance processes will be addressed in future iterations.

Structure of this Implementation Guide

This FHIR Implementation Guide is organized across the following tabs:

IG Home: Provides an orientation outlining objectives, background, and scope

Home: This home page

Background: Placing this work in the wider context

Implementation Best Practice: Provides some general pointers on implementation, and also picks out key points from different audience perspectives.

Guidance: Describes how the technical work was approached and why certain decisions were made

Use Cases and Workflows: Provides a view to use cases covered in this Implementation Guide as well as those others are working on and future potential use cases across stakeholders

Protocol Preparation: A guide to preparation of a protocol for submission according to the M11 format

Information Models: Explains how the USDM, M11 and FHIR models are related

FHIR Representation: Shows how elements of the protocol are represented in FHIR. Also provides a link to a mapping spreadsheet.

Bundles: Discusses representation of protocol sections within FHIR bundles and the operational consequences

Artifact Index: Lists the formal specification of the extensions, profiles, terminology and examples.