M11 (CeSHarP)

A protocol describes what a trial is intended to do. Data management, biometrics and other functions then turn those decisions into the documents and specifications they need. An endpoint depends on protocol content, collection fields and analysis rules remaining aligned. Keeping that work consistent is the problem these standards address.

ICH M11 CeSHarP gives protocol content a common structure and defines technical attributes for exchanging it electronically. CeSHarP stands for Clinical Electronic Structured Harmonised Protocol. It applies to interventional clinical trials of medicinal products across phases and therapeutic areas.

How the standards fit together

Each part of this guide answers a different question about the same trial information.

Foundation	The question it answers
M11 (CeSHarP)	How is the protocol content organized?
USDM/DDF	How can applications represent the trial as connected data?
SDR/MDR	How do reusable metadata and trial-specific definitions work together?
Controlled Terminology	How do values retain a consistent meaning?
360i	How do those foundations connect collection and analysis specifications?

We will follow a simplified endpoint throughout: change from baseline in an assessment score at Week 12. The example illustrates the relationships. The actual assessment and analysis rules belong to the particular trial.

The three parts of M11

M11 brings together a guideline, a protocol template and a technical specification. Each has a different job.

flowchart TD
    M11["ICH M11<br/>CeSHarP"]
    M11 --> Guideline["Guideline"]
    M11 --> Template["Protocol Template"]
    M11 --> Specification["Technical Specification"]

The Guideline explains the principles behind the harmonised protocol. The Protocol Template provides common headings and instructions for the content placed under them. The Technical Specification describes protocol components and their attributes. These include conformance and cardinality: whether information is required and how often it can occur.

This common structure helps authors prepare a protocol that reviewers can navigate consistently. It also gives systems a more precise basis for exchanging its content.

Put the endpoint in context

For our example, the protocol needs to explain the objective, define the endpoint and describe the assessment schedule. It also needs the statistical considerations that make the intended comparison clear.

M11 provides a consistent home for that information. The trial team still supplies the scientific decisions and supporting rationale. A common template makes those decisions easier to locate; their relationships also need to remain explicit when other teams use them.

A form designer needs to know which score to collect and at which visits. A statistician needs to know which observations define baseline and Week 12. Both are working from the same protocol intent.

From protocol content to connected data

M11 and USDM address complementary parts of protocol digitization. M11 includes both protocol organization and electronic exchange attributes. USDM models trial information and its relationships so applications can work with them directly.

The next step is to understand what that connected representation contains. USDM/DDF follows the endpoint from its description into the trial definition.