Protocol Synopsis Template: Every ICH M11 Field, and What 7 Real Synopses Look Like

Since 19 November 2025 there is an international standard for it. The ICH M11 template, known as CeSHarP (Clinical electronic Structured Harmonised Protocol), fixes the synopsis fields and their order. Below are those fields read from the final template, what 7 real published synopses look like in length and content, and a one-page synopsis template you can fill in.

What is a protocol synopsis?

A protocol synopsis is section 1.1 of a clinical trial protocol in the M11 layout. M11 describes it as a short summary of the key points of the trial, and allows cross references to the main body to keep it brief. It sits inside section 1, the Protocol Summary, with the trial schema (1.2) and the schedule of activities (1.3) after it.

Some funders ask for a synopsis on its own, before the full protocol exists: California's stem cell agency, CIRM, published a synopsis form for its clinical applicants. Teams also use it as the page everyone works from while the full protocol is being written.

The ICH M11 synopsis fields, in order

These come from the final ICH M11 template, adopted by ICH's regulatory members on 19 November 2025, read on 12 October 2026.

1.1.1 Primary and Secondary Objectives and Estimands. Summarized in natural, nontechnical language. If the objectives would run past half a page, include the most important ones and refer to section 3.

1.1.2 Overall Design. A table of fields, most chosen from a set list:

That is about 20 fields, plus the objectives. The trial schema, a diagram of arms and periods, follows in section 1.2.

What 7 real protocol synopses look like

We downloaded 7 full trial protocols posted on ClinicalTrials.gov and measured the synopsis or protocol summary section in each, from its first page to the trial schema or schedule of activities.

What the count shows:

• A synopsis is not short. 2 to 9 pages, with a median of 6. The shortest, from a university, ran 2 pages.
• Word counts run about 700 to 2,900, median about 1,490. Several are mostly tables, which is why a 5-page synopsis can hold under 1,500 words.
• None mention estimands. Every one of the 7 was written before M11 was final, and the word does not appear in any of the synopses. Under M11 it belongs in the first field.

A protocol synopsis template you can copy

This follows the M11 order. Fill each line with one short answer; move long text to the protocol body and cross-reference it, as M11 allows.

Title

• The full trial title, the protocol number and the phase.

1. Primary and secondary objectives and estimands (half a page at most)

• Primary objective, as a plain question: does X do Y compared with Z?
• Primary estimand, in plain words: the population, the measure, the comparison and what happens if a participant stops treatment.
• Secondary objectives, one line each.

2. Overall design

• Intervention
• Intervention model
• Control type and control description
• Intervention assignment method, and stratification
• Drug/device combination product: yes or no
• Population type, diagnosis or condition, and age range
• Sites: single or multi-site, and where
• Master protocol: yes or no
• Adaptive design: yes or no
• Number of arms
• Blinding: who is blinded, or open-label
• Number of participants: target or maximum
• Duration of intervention and of participation, per participant
• Committees: independent first, then others

3. Trial schema

• Screening, assignment, each treatment period and follow-up, with the length of each.

A one-page protocol synopsis, part by part

A full synopsis runs several pages, as the 7 above show. A one-page version is what you hand to a site team, a steering committee or a funder who needs the trial in a minute, with the full synopsis behind it. This sample was made with MakeOnepagers; the trial and protocol number are invented.

Edit this template

The M11 order on one sheet: objectives, the design table and the schema.

What each part does:

1. Objectives as questions. Primary: does a coached daily walking program help people walk farther 12 weeks after knee replacement than standard physical therapy alone, measured by the 6-minute walk distance? Secondary: does it lower knee pain, and do people keep walking after the coaching ends?
2. The design table, in M11's own field names. Intervention, model (parallel), control (standard of care), assignment (block randomization), population (patients 50 to 80 within 4 weeks of surgery), 6 US hospitals, 2 arms, blinded outcome assessor, a target of 240 participants, 12 weeks of intervention and 24 of participation, an independent Data Monitoring Committee.
3. The schema in four steps: screening for 2 weeks, randomization, 12 weeks of the walking program or standard therapy, and 12 weeks of follow-up.

What to add for an M11 synopsis: the estimand. For this sample, it could read: the difference in average 6-minute walk distance at week 12 between the two groups, for everyone randomized, whether or not they kept up the program. Add the four yes-or-no fields too (stratification, combination product, master protocol, adaptive design) when your reviewer expects the full M11 list.

Open it and replace the sample trial: protocol synopsis template.

How to write the objectives in plain language

M11 asks for the objectives and estimands in "natural, nontechnical (layperson) language". Three habits help.

• Write the primary objective as a question with a comparison in it. "To evaluate efficacy" is not a question. "Does the program help people walk farther than therapy alone?" is.
• Name the measure and the time point. The 6-minute walk distance at week 12, not "functional outcomes".
• Say what happens when people stop. That is the part of an estimand most summaries leave out, and it changes the answer.

Synopsis, protocol summary or executive summary?

Protocol synopsis mistakes

• Objectives with no comparison. A reader cannot tell what the trial will prove.
• No numbers in the design. "Several sites" and "approximately enough participants" tell a reviewer nothing. Give the count.
• Duration as one figure. M11 separates time on intervention from time in the trial. A participant in the sample trial is treated for 12 weeks but stays for 24.
• Blinding as one word. "Double-blind" hides who is blinded. M11 asks for the roles.
• A synopsis that does not match the protocol. Every amendment that changes the design has to change the synopsis too.

Protocol synopsis checklist

• Title, protocol number and phase
• Primary objective as a question, with its measure and time point
• The primary estimand in plain words
• Secondary objectives, one line each
• Intervention, model, control and assignment method
• Population type, condition and age range
• Sites and where they are
• Number of arms and who is blinded
• Number of participants, target or maximum
• Duration of intervention and of participation
• Committees
• A schema from screening to follow-up

Make your one-page protocol synopsis

Open the free protocol synopsis template, replace the walking trial with your own design in M11's field names, add your estimand, and download it as a PDF for your site team or steering committee. Writing the grant behind the trial? Our guide to the Specific Aims page template covers the NIH side.