Fill in the title, design, population, objectives, endpoints, criteria, statistics and safety fields and get a clean synopsis under standard headings, with empty sections marked. Copy it into your protocol, ethics submission or funder form.
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Title, number, sponsor, registration
Phase, design, population
Objectives and endpoints
Interventions, duration, sample size
Key eligibility criteria
Statistical methods and safety monitoring
Check against the full protocol
Protocol synopses in brief
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The demo is an invented hypertension trial. Load it to see the layout, then clear it and enter your own study. Lines in the objectives, endpoints and criteria fields become a numbered list. Nothing is saved or sent.
PROTOCOL SYNOPSIS TITLE A randomised, double-blind, placebo-controlled trial of Demo-101 in adults with mild hypertension ACRONYM DEMO-HTN PROTOCOL NUMBER DEMO-2027-01 PROTOCOL VERSION AND DATE Version 1.0, 1 February 2027 SPONSOR Example University (demo sponsor) TRIAL REGISTRATION To be registered before first participant in PHASE Phase 2 STUDY DESIGN Parallel-group, randomised 1:1, double-blind, placebo-controlled, superiority STUDY POPULATION Adults aged 30 to 70 years with untreated seated systolic blood pressure of 140 to 159 mmHg NUMBER OF PARTICIPANTS 120 participants (60 per arm), allowing for 10% dropout SITES 6 sites in 2 countries INVESTIGATIONAL PRODUCT AND COMPARATOR Demo-101 10 mg once daily or matching placebo once daily for 12 weeks STUDY DURATION 12 weeks of treatment plus a 2-week follow-up; 18 months overall PRIMARY OBJECTIVE To compare the effect of Demo-101 with placebo on seated systolic blood pressure at week 12 SECONDARY OBJECTIVES To compare diastolic blood pressure, the proportion with systolic blood pressure below 140 mmHg, and safety and tolerability PRIMARY ENDPOINT Change from baseline in seated systolic blood pressure at week 12 SECONDARY ENDPOINTS 1. Change in seated diastolic blood pressure at week 12 2. Proportion with systolic blood pressure below 140 mmHg at week 12 3. Incidence of adverse events KEY INCLUSION CRITERIA 1. Age 30 to 70 years 2. Seated systolic blood pressure 140 to 159 mmHg on two occasions 3. Written informed consent KEY EXCLUSION CRITERIA 1. Secondary hypertension 2. Pregnancy or breastfeeding 3. eGFR below 45 mL/min/1.73 m2 STATISTICAL METHODS Analysis of covariance on the change in systolic blood pressure, adjusted for baseline value, in the intention-to-treat population; two-sided alpha 0.05 SAFETY MONITORING Adverse events recorded at each visit and graded for severity; serious adverse events reported to the sponsor within 24 hours; independent safety review after 40 participants
Text assembly only: the tool arranges what you type under standard synopsis headings and marks empty sections. It does not write, check or improve content and does not use AI. A synopsis is a summary, so keep each entry short and make sure it matches the full protocol. Nothing is stored or sent; the text stays in your browser.
The headings
Identification. Title, acronym if any, protocol number, version and date, sponsor, and the trial registration number or the intended registry. A reviewer should know within five seconds which protocol version the summary belongs to.
Design and population. Phase, design, and population come together. Say whether the trial is randomised, parallel or crossover, blinded or open, controlled by placebo or active comparator, and what framework applies (superiority, non-inferiority, equivalence). Describe the population by the characteristics that determine eligibility, not by the disease alone. The SPIRIT checklist is a good test of whether the full protocol covers these points.
Objectives and endpoints. Primary objective, secondary objectives, and the matching endpoints. A well-defined endpoint names the measurement, the time point and the summary measure, and each objective should have an endpoint. The clinical trial endpoints glossary entry sets out the difference between primary, secondary and exploratory.
Interventions, sample size and duration. Dose, route, schedule and comparator; the number of participants and the basis for it; the length of treatment and follow-up and the overall duration. The sample size calculation entry explains the assumptions to state, and the clinical trial timeline calculator helps with overall duration.
Eligibility, statistics and safety. Only the key inclusion and exclusion criteria belong in a synopsis, usually three to eight each. For statistics, give the primary analysis method, the population it uses and the alpha. For safety, say how adverse events are collected and graded, the serious adverse event reporting window and any independent safety review.
Reviewing the output
| Weak entry | Why it fails | Better entry |
|---|---|---|
| Primary endpoint: blood pressure | No measure, time or summary | Change from baseline in seated systolic blood pressure at week 12 |
| Population: adults with hypertension | Does not define who qualifies | Adults 30 to 70 years with untreated seated systolic blood pressure of 140 to 159 mmHg |
| Sample size: enough to detect a difference | No number or assumption | 120 participants (60 per arm), 10% dropout allowed |
| Duration: about 3 months | No separation of treatment and follow-up | 12 weeks of treatment plus a 2-week follow-up |
| Safety: AEs will be monitored | No grading, window or oversight | AEs graded at each visit; SAEs to sponsor within 24 hours; independent review after 40 participants |
All examples belong to the invented demo study. Replace them with the figures in your own protocol and statistical analysis plan.
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After the synopsis
The synopsis is the shortest check of your thinking. If you cannot fill a field in one or two lines, the design probably has an open question, and it is cheaper to find it now than after ethics review. Once it is complete, expand it into the full document with the clinical trial protocol template, and read how to write a clinical trial protocol for the section-by-section logic. Registering the trial is a separate step: the ClinicalTrials.gov registration guide shows how much of the synopsis carries across.
Keep the synopsis in step with amendments. When the protocol changes, update the synopsis, the version and the date at the same time, and record the amendment in your version history. Mismatches between a synopsis, a registry entry and the protocol are one of the easier things for a reviewer or inspector to find.
In Capture
This page makes a summary. Capture’s AI study builder goes the other way: it reads the full protocol and drafts the visit schedule and the forms, and you review everything before it is saved.
protocol_v3.pdf
Draft study
Before you submit it
The synopsis header carries the same version and date as the protocol.
Objectives and endpoints are listed in matching order.
Sample size, dropout allowance and alpha match the statistical section.
Only the main inclusion and exclusion criteria, the full list stays in the protocol.
The serious adverse event reporting time and any independent review are written.
Registry and identifier, or the intended registry and timing.
A short summary of a clinical trial protocol, usually one to two pages, giving the title, design, population, interventions, objectives, endpoints, sample size, duration, key eligibility criteria, statistical methods and safety monitoring.
Identification (title, protocol number, version, sponsor, registration), phase and design, population, interventions and comparator, number of participants, duration, primary and secondary objectives and endpoints, key inclusion and exclusion criteria, statistical methods and safety monitoring.
No. It places the text you enter under standard headings and marks empty sections. It does not write, check or improve content.
The ICH E6 protocol content list does not call for a separate synopsis, but many ethics committees, funders and sponsors request one, and the clinical study report has a synopsis section of its own. Check the requirement of whoever you are submitting to.
Usually one to two pages. Keep each entry to a line or two, list only the key eligibility criteria, and leave detail to the full protocol.
Yes. Copy the text and paste it into the document. Check that it matches the full protocol and update it whenever the protocol is amended.
No. What you type is processed in your browser and is not saved or transmitted.
Keep exploring
Clinical trial protocol template
Expand the synopsis into a full protocol.
How to write a clinical trial protocol
Section-by-section guide.
SPIRIT checklist generator
Check protocol completeness.
Protocol to study setup
AI-drafted schedule and forms.
ClinicalTrials.gov registration guide
Registering the trial.
Upload your protocol, review the drafted schedule and forms, and test everything in a free sandbox. No credit card, pay only when you go live.