# Home - Clinical Study Protocol v1.0.0-ballot2

## Home

**Note to Reviewers**

1. **This Implementation Guide is concerned with mapping from externally developed content. The licensing terms for that usage is acknowledged and fully detailed in the [Licenses](licenses.md) section.**
1. The content is based on FHIR R6. This is to take advantage of new features in the[ResearchStudy](https://hl7.org/fhir/6.0.0-ballot4/researchstudy.html)resource. There are planned to be backports to earlier FHIR releases in future. We are interested to know what backport requirements implementers have.
1. The project team requests community feedback on the proposed IG name, “Clinical Study Protocol.” There's an active conversation within the community regarding the use of "clinical study" or "clinical trial" within the name, with multiple implications of each. The project team wants to reach a decision that best serves collective community goals.Background: the IG is designed to support alignment with global initiatives related to regulated research, particularly those led by ICH—a group comprised of regulatory bodies and trade representatives from around the world. ICH has developed a harmonized guideline for the protocol template, and their workgroup has specifically requested that Vulcan create this IG to ensure FHIR can facilitate the exchange of protocols compliant with their guideline. Other organizations, including CDISC and TransCelerate, have established artifacts in use with which this IG enables compatible use of FHIR. This represents a unique opportunity to synchronize FHIR with global constituents of clinical research, in particular regulators who are poised to adopt the ICH guideline.The IG name was selected to maximize alignment with ICH’s standards, referencing ICH M11 and E8, which define the "Clinical Study Protocol." Historically, the project was called “Utilizing a Digital Protocol for Clinical Trials,” and was later updated to “Pharmaceutical Research Protocol” after HL7 review. However, the latter raised concerns with the user community during the ballot process due to its specificity as the IG is meant to cover a wide range of clinical studies—not just pharmaceutical research. On September 22, 2025, the project team voted to adopt “Clinical Study Protocol” to ensure the IG accurately reflects its broad scope. The IG offers a FHIR-based structure applicable across all types of clinical studies, providing a universal and reusable standard rather than one limited to a specific domain.The chosen name aligns with a broader global initiative: ICH M11 (CeSHarP), EMA’s “Clinical Study Protocol Template,” and Vulcan’s “Clinical Study Protocol” all represent coordinated efforts to standardize protocol structures across study types and regions. We are keen to hear your thoughts on whether “Clinical Study Protocol” is the most appropriate name for this IG, or if “Clinical Trial Protocol” would be preferable.

### 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](https://hl7.org/fhir/6.0.0-ballot4/researchstudy.html) resource. There will be backports to earlier FHIR releases in future. 

**This Implementation Guide is concerned with mapping from externally developed content. The licensing terms for that usage is acknowledged and fully detailed in the [Licenses](licenses.md) section.**

**What is a clinical study protocol?** Conduct of clinical studies is guided by the International Council for Harmonization of Technical (ICH) Requirements for Human Use, Guideline for Good Clinical Practice (GCP) E6 which specifies the protocol as “A document that describes the objective(s), design, methodology, statistical considerations and organisation of a trial,” incorporating 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 study.

**Who can benefit from utilizing a digital protocol?** Users of protocols exist across the full continuum of clinical and translational research. Traditional research conducted by the biopharmaceutical industry involves complex processes with numerous 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](https://www.hl7.org/documentcenter/public/white-papers/2025%20State%20of%20FHIR%20Survey%20Report.pdf)). 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](https://hl7vulcan.org/)?** 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** ](background.md) section in this Implementation Guide under the ** Home** section of the banner and in the [Links](links.md) section under the ** Support** section of the banner.

### Technical Overview

This Implementation Guide describes the representation of a protocol in FHIR format aligned with the ICH M11 CeSHarP Template, Guideline, and Technical Specification. This initial version of the IG is focused primarily on exchange of protocols as traditional "documents", i.e., narrative text, with only some elements exchanged as structured content. An approach which enables more digital structuring of elements aligned to M11 is addressed by USDM, the developed by CDISC in partnership with TransCelerate as part of Digital Data Flow initiative. Future versions this IG are intended to expand integration of USDM and FHIR in order to enable exchange of additional structured protocol content in FHIR-based systems. As additional IGs may be developed for specific use cases which this IG serving as the base or core. Both M11 and USDM are represented in the FHIR Representation mapping spreadsheet (found under [Downloads](downloads.md) section of the banner).

 The key FHIR resources used are [ResearchStudy](https://hl7.org/fhir/6.0.0-ballot4/researchstudy.html) and [Composition](https://hl7.org/fhir/6.0.0-ballot4/composition.html), while also drawing on some patterns found in profiles and extensions from the [EBM IG](https://build.fhir.org/ig/HL7/ebm/en/index.html). 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 Workflow](use-cases.md) 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:

