Closure-to-disclosure sequence
Notify the end of the trial in that Member State within 15 days of the applicable end event.
Notify within 15 days from the end in the last Member State concerned.
Notify within 15 days from the end in the last country in which the trial was conducted.
For the general CTR case, submit within one year from the end of the trial. Paediatric trials can have a shorter deadline.
If the trial was intended to support a marketing authorisation, the marketing-authorisation applicant has a separate 30-day CSR obligation tied to the marketing-authorisation procedure.
Keep the main closure artifacts separate
Records the regulatory end event and date. It is a lifecycle notification and does not replace the later results submission.
Scientific summary using the content framework in CTR Annex IV. The Sponsor Handbook identifies CT Admin and CT Results Submitter as roles that can submit trial results.
Accompanies the final results and communicates the trial and overall results to readers without expert knowledge, using the content framework in CTR Annex V.
Can be submitted when the protocol provides for an intermediate analysis. EMA states that intermediate results are not published in CTIS.
Separate study report required under Article 37(4) where the trial was intended to support a marketing authorisation for the IMP.
Final results, layperson summaries and applicable CSRs must follow the current CTIS transparency rules for public and protected information.
First record the end state correctly
The CTR requires the sponsor to notify each Member State concerned of the end of the trial in that Member State within 15 days. The sponsor also notifies the end in all Member States concerned within 15 days from the end in the last Member State.
If the trial was conducted in third countries, the sponsor also notifies the global end within 15 days from the end in the last country.
For the broader lifecycle-event matrix, use CTIS trial and recruitment notifications.
Final results: the standard deadline is one year
Article 37(4) requires a summary of results accompanied by a layperson summary. The current Sponsor Handbook states that these are due within one year from the end of the clinical trial in all EU/EEA Member States concerned.
Paediatric trials: the July 2026 CTR Questions & Answers states that the summary of results is due within six months. For certain paediatric trials outside Article 46(1) of the Paediatric Regulation, a scientifically justified exception can extend submission to no later than 12 months.
If scientific reasons prevent submission within the normal timetable, the CTR requires the timing to be justified in the protocol and the intended submission timing to be specified.
Interim results follow a different publication rule
EMA states that an intermediate summary of results can be submitted before or after the trial has ended. It is uploaded through the trial-results area but is not subject to publication.
The Sponsor Handbook also warns that the CTIS interface can display wording that suggests an intermediate result is "for publication". EMA states that this wording does not change the publication rule for intermediate results.
Technical results and the layperson summary serve different readers
Uses the scientific content framework in Annex IV, including trial information, subject disposition, baseline characteristics, endpoints, statistical analyses and adverse events.
Uses Annex V and communicates the trial and overall results in language understandable to people without expert knowledge.
Is not a substitute for either summary. It is an integrated clinical and statistical report with its own marketing-authorisation trigger and CTIS workflow.
Prepare final results for publication before upload
EMA states that final summaries of results and layperson summaries are subject to CTIS publication rules. The Sponsor Handbook instructs sponsors to upload the first final document version as the version for publication and, where protected information must remain visible to Member States, to upload the corresponding unredacted version in the not-for-publication slot.
Only the latest submitted version of the final summary of results is subject to publication. Earlier versions remain in the secure workspaces.
Before upload, apply the CTIS transparency and redaction guide.
The CSR boundary: a separate marketing-authorisation obligation
Where the clinical trial was intended to be used for obtaining a marketing authorisation for the investigational medicinal product, Article 37(4) requires the marketing-authorisation applicant to submit the CSR within 30 days after the marketing authorisation is granted, the procedure for granting it is completed, or the application is withdrawn.
Can view, create, edit, submit, update and withdraw a CSR and can assign CSR roles.
Can manage CSR submissions but cannot manage CSR-role assignments.
Can view draft or submitted CSRs but cannot submit, update or withdraw them.
Track the CSR deadline outside CTIS alerts. EMA states that sponsor users do not receive an alert when the CSR due date is approaching.
Final closure checklist
- Confirm that end dates match the protocol definition of end of trial.
- Record the end in each applicable Member State and the all-Member-State end within the required timing.
- Record the global end if the trial also ran outside the EEA.
- Calculate the final-results deadline from the applicable end event and check the paediatric rules where relevant.
- Prepare the scientific summary and layperson summary for their different audiences.
- Apply the correct public and protected document versions under the CTIS transparency rules.
- If Article 37(4) CSR requirements apply, assign CSR ownership and track the separate 30-day marketing-authorisation trigger.
Official sources and resources
- Regulation (EU) No 536/2014, especially Article 37 and Annexes IV and V.
- EMA CTIS Sponsor Handbook, version 6.4, sections 5.1 to 5.3.
- European Commission EudraLex Volume 10, including the July 2026 CTR Questions & Answers.
- EMA CTIS training and support.
Last reviewed: 19 September 2026