HealthLiteracyCopilot by HealthcareGPSFree kit · no form
Is your lay summary readable before it's due?
A checklist that follows the Annex V headings and Good Lay Summary Practice, a deadline card, a synthetic before and after, and a review-hours worksheet. All of it is on this page.
Last reviewed 2026-10-09
A review aid, not regulatory advice.
Every EU trial now needs one
Since 2025-01-31, all trials in the EU and EEA run under the Clinical Trials Regulation. Each one must post a summary of its results written for the public, in the languages its trial countries require. The summary has to be accurate and easy to read. Most teams write it at the end, under a deadline, after the scientific report.
Deadline card
Count from the end of the trial in all countries. Check each trial's own timeline with your regulatory team.
Months from the end of the trial
Paediatric trials
6 months
Most trials
12 months
Non-therapeutic phase 1 trials
30 months
| Trial type | Due after the end of the trial |
|---|---|
| Most trials | Within 12 months |
| Paediatric trials | Within 6 months |
| Non-therapeutic phase 1 trials | Within 30 months |
A results paragraph, before and after
One paragraph from a synthetic summary. The numbers in the notes match the changes. Brackets mark what your team fills in.
Synthetic example: Overall results. Not a member or patient document.
The primary efficacy endpoint was met, with a statistically significant reduction in the mean change from baseline in the symptom severity score at week 12 in the treatment arm relative to placebo (p<0.001). The incidence of treatment-emergent adverse events was comparable between arms.
What did the study find?
After 12 weeks, people who took [study medicine] had fewer symptoms than people who took a placebo. A placebo looks like a medicine but has no medicine in it.
About the same number of people in each group had side effects. You can find the list of side effects in section [number].
This is the result of one study. It may not be the same for everyone. Talk to your doctor before you make any change to your treatment.
Words per sentence, before and after
Before
43 words in 2 sentences · longest 33 words
After
84 words in 8 sentences · longest 17 words
What changed and why
- The heading asks the reader's question.
- "Primary efficacy endpoint" and "p<0.001" become what changed for the people in the study.
- Placebo is explained the first time it appears.
- Side effects get their own pointer instead of "treatment-emergent adverse events".
- A closing line keeps the result in context and points to the doctor.
Review-hours worksheet
Lay summaries go through several review rounds, in each language. Add up your hours to see where the time goes. The first row is an example.
The example row
4 languages × 3 review rounds × 6 hours per round = 72 total hours. Each extra language adds a row of rounds, so the hours grow with every language you add.
| Trial | Languages | Review rounds | Hours per round | Total hours |
|---|---|---|---|---|
| Trial [number] (example) | 4 | 3 | 6 | 72 |
Type in the table, then download it for Excel or Google Sheets. Your entries stay in this tab: nothing is sent or saved, so download before you leave the page.
The lay-summary checklist
Check each draft against the parts the CTR asks for, then against the reading checks.
Complete this checklist: about 15 minutes
0 of 14 checked
The summary covers (CTR Annex V)
Written for the public (Good Lay Summary Practice)
Your answers stay in this tab: nothing is sent or saved. Download or print before you leave the page.
Sources
After the kit
Send a blank template, not a copy with a patient's or member's details.
Email me this resource
This resource is already open on this page. This sends you a link to it.
HealthcareGPS is SOC 2 Type II audited and HIPAA compliant. How we protect your documents
Questions
Will regulators accept a summary that passes this checklist?
We can't promise that. It is a review aid. Your scientific experts and regulatory team decide what is posted.
Which languages does it cover?
We measure English and Spanish, each with its own reading tests. Other languages are scoped one by one.