ICH M11, the Clinical electronic Structured Harmonised Protocol (CeSHarP), gives every interventional protocol the same headings in the same order, with a technical specification that turns key content into defined data elements. It reached ICH Step 4 on 19 November 2025. Here is what it contains, where it applies, and what it means when you build the study database.
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Protocol summary: synopsis, schema, schedule of activities
Most-used content first
Trial objectives and associated estimands
Estimand table per objective
Trial population: inclusion and exclusion
Trial intervention and concomitant therapy
Trial assessments and procedures
Adverse events and serious adverse events
Statistical considerations
Trial oversight, data governance, data protection
ICH M11 at a glance
The standard
Before M11, ICH guidelines described what a protocol should contain but not how to lay it out, so every sponsor used its own template. The M11 guideline says that variability makes protocols harder to search, review and assess, and that a common template should help sponsors and sponsor-investigators write protocols that are complete, unambiguous and aligned with quality by design. The package has three parts.
The guideline explains the design principles: build common core content, serve every stakeholder from investigators to ethics committees, define content for electronic exchange, design for reuse, and keep flexibility. The template gives the format and structure: a fixed table of contents, common headers, instructions for content, and conventions that mark which text is required and which is optional. The technical specification describes each structured content component with attributes such as definition, conformance (required, optional or conditional) and cardinality, so that protocol content can be exchanged electronically in an open, non-proprietary way. Under an agreement between ICH and CDISC, CDISC maintains the ICH controlled terminology used by M11 and publishes it after public review.
Two design choices stand out for site teams. The most-used information for running the trial, the synopsis, schema and schedule of activities, sits at the front. And appendix content carries the same weight as the main body. If you want a practical, fillable starting point, our clinical trial protocol template follows the same section logic; this page explains the guideline behind it.
Status as of October 2026
The ICH Assembly endorsed the draft M11 package for consultation on 27 September 2022. An updated draft of the technical specification went out for a second consultation in early 2025, and the regulatory members adopted the final guideline, template and technical specification at Step 4 on 19 November 2025.
In the EU, CHMP adopted all three documents on 11 December 2025 with a date for coming into effect of 11 June 2026, and EMA published them on 15 December 2025. In the US, FDA published M11 as final guidance for industry in May 2026, issued by CDER and CBER. FDA guidance is non-binding. We did not find an EMA or FDA statement that makes the M11 template a mandatory submission format; the guideline itself expects the template and specification to give a format acceptable to all ICH regulators. Because the template and specification are versioned under change control, download the current version from ICH or your regulator rather than reusing an old copy.
Step 2 draft
27 September 2022, guideline, template and specification
Second consultation
Updated technical specification, early 2025
ICH Step 4
19 November 2025
EU coming into effect
11 June 2026 (CHMP adopted 11 December 2025)
FDA final guidance
May 2026, CDER and CBER
From protocol to database
Section numbers follow the M11 template. The right-hand column shows what each one becomes in an EDC.
| M11 section | What the template asks for | What it becomes in the database |
|---|---|---|
| 1.3 Schedule of activities | Procedures at every visit and every participant contact, including phone contacts and tests used for eligibility, randomisation or discontinuation. Allowable windows for all visits and procedures. Tabular format recommended. | The visit schedule, visit windows and the form assigned to each visit. |
| 3.1 and 3.2 Objectives and estimands | Each primary and secondary objective with its estimand, described with reference to ICH E9(R1), including the endpoint at a minimum. | Endpoint fields, plus fields for intercurrent events such as treatment discontinuation or rescue medication. |
| 5.2 and 5.3 Inclusion and exclusion | Numbered eligibility criteria. | An eligibility checklist form with edit checks. |
| 6.7 Assignment, randomisation and blinding | How participants are allocated and who is blinded. | Randomisation settings, strata and blinded roles. |
| 6.10 Concomitant therapy | Permitted and prohibited medicines and how they are recorded. | A concomitant medications form with repeating rows. |
| 8 Trial assessments and procedures | Efficacy, safety, PK, biomarker and other assessments. | Assessment forms, calculated fields and units. |
| 9 Adverse events and SAEs | Definitions, timing and procedures for collection and reporting. | AE form, SAE workflow and reporting timelines. |
| 12.1 Clinical laboratory tests | The laboratory parameters collected. | A lab table with analytes, units and reference ranges. |
Why structure matters
Today most study builds start with someone reading a PDF protocol and retyping the schedule of activities into a database. The M11 guideline names "standardised clinical trial data capture" as one of the intended reuses of protocol content. When the schedule of activities is always a table in section 1.3 with windows stated, and every estimand names its endpoint and intercurrent events in a defined structure, the step from protocol to database becomes more predictable for people and for software. It also makes amendments easier to trace: the template has a fixed place for the amendment rationale and summary of changes, and section 12.3 records prior amendments.
M11 is not the only standard in this space. The CDISC Unified Study Definitions Model (USDM), developed through the CDISC and TransCelerate Digital Data Flow initiative, is designed so that the M11 data elements form a subset of the model, which means a USDM-based study definition can carry M11 content. HL7 is also developing a FHIR implementation guide for exchanging protocols. These are related but separate efforts; M11 itself leaves room for regional choices on the exchange format, so watch your regulator's technical requirements before you invest in tooling.
The estimand section deserves extra attention. If the primary estimand handles treatment discontinuation with a treatment-policy strategy, you need data collection to continue after a participant stops treatment, and the database must record why and when they stopped. Our guide on how to write a clinical trial protocol and the glossary entry on clinical trial endpoints give more background.
Upload the protocol, review the drafted visits and forms, and test everything in a free sandbox. No credit card, and you pay only when you go live.
Getting started
A practical order of work for a sponsor or sponsor-investigator writing a new protocol.
Download the guideline, template and technical specification from ICH, EMA or FDA. Keep the ICH copyright acknowledgement if you adapt the template, and label your changes.
Line up your current protocol headings against the M11 table of contents. Content usually moves rather than disappears, for example data protection and data governance get their own sections under trial oversight.
Build it as a table with every visit, every remote contact and a window for each. Use the schedule of assessments builder to test that the visits and windows make sense.
Fill in the estimand table for each primary and secondary objective, then list the data each intercurrent event strategy needs.
Draft the visit schedule and forms from the protocol, add edit checks, and export a blank eCRF PDF for the ethics submission. See protocol to study setup software.
Record each amendment's rationale and summary of changes in the M11 places, and update the database to match. Protocol amendments without change orders covers the database side.
M11 is the ICH topic code for the Clinical electronic Structured Harmonised Protocol, abbreviated CeSHarP. It consists of a guideline, a protocol template and a technical specification.
The ICH regulatory members adopted the guideline, template and technical specification at Step 4 on 19 November 2025. In the EU they came into effect on 11 June 2026, and FDA issued them as final guidance in May 2026.
ICH guidelines are guidance. We found no EMA or FDA statement that makes the M11 template a mandatory protocol format as of October 2026, though regulators expect to receive protocols in this harmonised structure. Check your regulator's current requirements before submission.
Interventional clinical trials of medicinal products across all phases and therapeutic areas, including biologics, vaccines, drug-device combinations developed as drugs, and cell and gene therapies. It is not written for observational studies.
CDISC maintains the ICH controlled terminology used by M11 under an agreement with ICH. The CDISC Unified Study Definitions Model (USDM) is designed so the M11 data elements are a subset of it. They are related but separate standards.
Capture's AI study builder reads protocol documents (PDF, DOCX, DOC) and drafts the visit schedule and forms for human review, so an M11-formatted protocol can be uploaded like any other. Capture does not import M11 technical specification or USDM data files.
Keep exploring
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How to write a clinical trial protocol
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Schedule of assessments builder
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ICH E6(R3) Annex 2 guide
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AI study builder
Draft visits and forms from your protocol, then review.
Upload a protocol, review the drafted schedule and forms, and test it free. No credit card, and you pay only when you go live.