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USFDA Guidance: M11 Technical Specification & Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)

In a major step toward global harmonisation of clinical trial processes, the U.S. Food and Drug Administration (FDA) and the International Council for Harmonisation (ICH) have introduced a transformative protocol standard: the Clinical Electronic Structured Harmonised Protocol (CeSHarP).


Released under the M11 Guideline, this initiative is comprised of two key draft guidance documents—"M11 Technical Specification" and "M11 Protocol Template"—aimed at streamlining the development, review, and sharing of clinical trial protocols across international regulatory environments.


What is CeSHarP and Why Does it Matter?

CeSHarP is the acronym for Clinical electronic Structured Harmonised Protocol, an ICH initiative designed to create a common digital language and layout for interventional clinical trial protocols. Its key goal is to eliminate regional inconsistencies and duplication in protocol submission formats.

Historically, trial protocols—although serving the same scientific and regulatory purposes—varied significantly between sponsors and countries.

CeSHarP, as defined in the M11 Template and Technical Specification, provides a harmonised and machine-readable format that ensures uniformity, reduces ambiguity, and accelerates the regulatory review process.


M11 Technical Specification: The Digital Framework

The M11 Technical Specification complements the template by defining how the protocol information is structured electronically. It outlines how data elements, headings, values, and metadata should be formatted for compatibility with regulatory systems.

Key features of the technical specification include:

  • A breakdown of each template variable, including data types, cardinality, conformance rules, and relationships between protocol components.

  • Detailed guidance on how to encode trial titles, sponsor information, trial phases, and protocol versions in structured, searchable formats.

  • Reuse and repetition rules that promote consistency across multiple documents or trial sites.

By converting traditionally unstructured documents into structured datasets, the specification facilitates automation, system integration, and interoperability.


M11 Template: The Protocol Blueprint

The M11 Template (CeSHarP) provides a structured, section-by-section layout for interventional clinical trial protocols. It is suitable across all phases (from first-in-human to post-approval) and across therapeutic areas.

Each section in the template—from trial title and objectives to statistical methods and ethical considerations—uses defined formatting conventions, including:

  • Universal text (mandatory content),

  • Conditional text (included based on trial context),

  • Optional text (customizable),

  • Controlled terminology, and

  • Text insertion points for trial-specific data.

This structure allows both flexibility and standardisation, enabling companies to tailor protocols while adhering to global expectations.

The template also defines specific terminology preferences (e.g., using “participant” instead of “subject” and “trial intervention” instead of “investigational product”), which supports clarity in multi-jurisdictional trials and aligns with evolving ethical language.


While the documents are currently in draft form (as of February 2025), sponsors are encouraged to start preparing for adoption:

  • Familiarise yourself with the M11 template and structure.

  • Evaluate existing protocol authoring tools for compatibility with CeSHarP.

  • Begin training clinical and regulatory teams on structured protocol thinking.

  • Engage with EDC and eTMF vendors about M11-compliant workflows.

Adopting this format early will not only smooth future compliance but also future-proof protocol submissions against evolving digital regulatory standards.


For more details, check the below Official Resources:

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