Reporting when a clinical trial is completed
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All reporting obligations following the end of a clinical trial must be done via Clinical Trials Information System (CTIS).
Definition
The end of a clinical trial means the last visit of the last subject, or at a later point in time as defined in the protocol, in accordance with Article 2 (26) of the clinical trial Regulation (EU) 536/2014.
End of clinical trial notifications
According to Chapter VI, Article 37 of the clinical trial Regulation (EU) 536/2014, the Sponsor is required to notify each Member State concerned at the end of a clinical trial.
End of trial - Member State
When the clinical trial has ended in aa given EU/EEA Member State concerned, the Sponsor must submit an end-of-trial notification within 15 days of the end of the trial in that - Member State.
End of trial - EU/EEA
When the clinical trial has ended in all EU/EEA Member States concerned, the Sponsor shall submit an end-of-trial-EEA notification within 15 days of the end of the trial in all EU/EEA Member States concerned.
End of trial - Global
When the clinical trial has ended in all EU/EEA Member States concerned and in all third countries where it was conducted, the Sponsor shall submit a global end-of-trial notification within 15 days of the global end of the trial.
Summary of results
Irrespective of the outcome of a clinical trial, the Sponsor shall submit a summary of the results no later than one year after the trial ended. For paediatric trials, the summary of results must be submitted within six months after the conclusion of the clinical trial. The minimum requirements for the summary are provided in Regulation (EU) No 536/2014, Annex IV.
Additionally, the Sponsor shall submit a summary of the results written in layperson language. The minimum requirements for this summary are provided in Regulation (EU) No 536/2014, Annex V.
If, for scientific reasons, it is not possible to submit a summary of the results within one year, it must be submitted as soon as they become available. A later submission of results must be described and justified in the protocol, which must also specifyt when the summary will be submitted.
Clinical study report (CSR)
In cases where the clinical trial is intended to be used for obtaining a marketing authorisation for the investigational medicinal product (IMP), the applicant must, in addition to the summary of results, submit a clinical study report (CSR) within 30 days after the day the marketing authorisation has been granted, the procedure for granting the marketing authorisation has been completed, or the applicant for marketing authorisation has withdrawn the application.
A CSR is a report on the clinical trial presented in an easily searchable format and prepared in accordance with Annex I, Part I, Module 5 of Directive 2001/83/EC. Please also refer to ICH guideline E3 on structure and content of CSR.
Relevant links