Under the EU Clinical Trials Regulation, ending a trial starts a reporting clock. This guide sets out the end-of-trial notifications, the summary of results, the layperson summary, the clinical study report and the transparency rules, then shows how a data team prepares for them. Not legal advice.
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months after end of trial
Short window: days, not months
Summary generally due within 12 months
The short answer
The duties
The CTR treats the end of a trial as a series of notifications and submissions in CTIS. First the sponsor notifies the end of the trial in each member state concerned and then in all of them, and also reports temporary halts and early terminations. The regulation sets short windows for these notifications, counted in days, so the person who owns the CTIS workspace needs to be told the moment the last participant has completed the last visit. Our CTIS submission guide explains how the portal works and who has roles in it, and the EU CTR software guide covers what the regulation changed overall.
After the end notifications, the sponsor submits the results documents. This guide focuses on those, because they are the part that depends on your data team. Everything below is orientation. The article text, the annexes and the Commission and EMA question and answer documents are what apply, and some points, such as the shorter paediatric period and the clinical study report timing, are described here only in general terms because they depend on the details of the trial.
The package
Summarised from the regulation and public guidance. Always confirm the timing for your trial in the current text.
| Document | What it is | Timing (general terms) |
|---|---|---|
| Summary of results | Technical summary of the results of the trial, with content set out in an annex to the regulation, submitted to CTIS | Within one year of the end of the trial in all member states concerned; a different period applies to some paediatric trials; a later date can be justified by scientific reasons set out in the protocol |
| Layperson summary | A plain-language summary for the public, which must address ten elements listed in Annex V | Submitted with the summary of results; EU guidance summaries describe it as mandatory for all trials from 31 January 2025 |
| Clinical study report (CSR) | The full report of the trial, relevant where the trial supports a marketing authorisation application | Tied to the marketing authorisation application or its withdrawal; check Article 37 and the guidance |
| Interim results information | Where a protocol-specified interim analysis or a first-version arrangement applies | As set in the protocol and the regulation; check the text |
Dates and exceptions are the most error-prone part of this topic. Verify with the regulation, the EMA sponsor handbook and your regulatory adviser.
Transparency
The CTR created a public EU database, and CTIS is the system behind it. The principle is that information on trials, including the results, is public unless one of the listed grounds for confidentiality applies. In general terms those grounds protect the personal data of participants and others, commercially confidential information, and confidential communications between member states about assessment and the effective supervision of trials by member states. Participant-level data is not part of what is made public.
CTIS applies detailed transparency rules for what is published and when, including options to request that some information be deferred. The EMA publishes these rules and has revised them over time, so check the current version before you decide what to mark as confidential. A practical consequence is that text you write for the summary and the layperson summary is written for publication. Review it as you would a paper: no participant identifiers, no small-cell tables that could point to individuals, and no commercially sensitive process detail that is not needed to understand the results.
Transparency in the EU runs alongside registries elsewhere. If your trial is also registered on ClinicalTrials.gov, the results fields and dates differ, and the content must stay consistent. See our ClinicalTrials.gov registration guide for the US side.
Test your database lock, exports and data dictionary in the free sandbox with sample data, so the results clock is not the first time you try them.
Data readiness
State exactly which event is the end of the trial (usually last visit of the last participant, unless the protocol says otherwise) and who tells the CTIS owner. The date you notify drives the deadline.
Work backwards from the results deadline: summary and layperson drafting, statistical analysis, database lock, final cleaning. Add a buffer for review and sponsor sign-off.
Open queries, missing data and unresolved safety fields are what delay a lock. Use the monitoring view and query reports during the study, not only at the end. See clinical data cleaning.
Follow a written lock procedure and keep the evidence. Our database lock checklist lists the steps and owners.
Export the analysis dataset with a data dictionary and, if your statisticians work in CDISC, SDTM datasets. Keep the audit trail export alongside.
Write the technical summary and the layperson summary only from locked, reviewed numbers. Have a second person check every figure against the tables.
Move the final records into the trial master file and agree retention. See data archiving and retention.
In Capture
A dashboard of open queries, forms awaiting sign-off and visits outstanding shows whether the dataset is on track to lock. After lock, Capture exports CSV or Excel with an automatic data dictionary, SDTM as SAS XPT with Define-XML, and the field-level audit trail. Capture does not write the summaries and does not submit anything to CTIS: that stays with the sponsor and its regulatory team.
Participants completed
118 / 120
Open queries
14
Forms awaiting sign-off
9
Days to planned lock
21
open queries
open queries
open queries
Checklist
Use with the EMA sponsor handbook and your regulatory team.
Definition in the protocol, one named person who notifies, and a trigger when the last visit closes.
Date derived from the notified end, with any paediatric or protocol-specified exception checked against the text.
Lock date, analysis plan sign-off and a statistical report template, prepared before the last visit.
Content follows the annex to the regulation, with figures reconciled to the tables.
Covers the ten Annex V elements in plain language and has been read by someone outside the project.
No participant-identifiable detail, confidentiality grounds considered, and any deferral decided under the EMA rules.
Owner and date linked to the marketing authorisation strategy.
Final records in the trial master file and the same results consistent on ClinicalTrials.gov or other registries.
Under Article 37 of Regulation (EU) No 536/2014, the summary of results is generally due within one year of the end of the trial in all member states concerned. Shorter periods are described for certain paediatric trials and a later date can be set for scientific reasons in the protocol. Check the current text for your trial.
A plain-language summary of the results for the public, submitted with the summary of results. Annex V of the regulation lists ten elements it must address, and EU guidance summaries describe submission as mandatory for all trials from 31 January 2025.
The duty applies regardless of the outcome, and early termination has its own notification duties. Trials ended early still have summaries to submit, with timing set in the regulation. Confirm the details for your case.
The CSR is relevant where a trial supports a marketing authorisation application, and its submission is tied to that application or its withdrawal. What becomes public follows the CTIS transparency rules, so check the current EMA documents.
No. The public database carries trial information and results summaries. Participant personal data is protected, and sponsors should avoid identifiable detail and very small cells in anything they write for publication.
The sponsor is responsible for submitting and for their accuracy and completeness, even where a CRO or regulatory vendor prepares or uploads the documents on its behalf.
No. Capture provides the data capture and export side, including lock-ready data, exports with a data dictionary, SDTM output and the audit trail. Submission to CTIS is done by the sponsor or its representative in the portal.
No. Article numbers, periods and exceptions here are for orientation. Check Regulation (EU) No 536/2014, the annexes, the EMA documents and your regulatory adviser before relying on a date.
Keep exploring
EU CTIS submission guide
The portal and the dossier.
EU CTR software guide
What the regulation changed.
Database lock checklist
Lock with evidence.
Data archiving and retention
After the report.
ClinicalTrials.gov registration
The US registry side.
Clinical data cleaning
Get to lock faster.
Database lock
Short definition.
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