Reporting when a clinical trial is completed
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All reporting obligations after a clinical trial has been completed must be done via Clinical Trials Information System (CTIS).
Definition
End of clinical trial means the last visit of the last subject, or at a later point in time as defined in the protocol.
End of clinical trial notifications
End of trial - Member State
When the study is completed in an affected EU/EEA Member State the sponsor shall submit the notification within 15 days from the end of the clinical trial within the respective Member State.
End of trial - EU/EEA
When the study is completed in the EU/EEA the sponsor shall submit the notification within 15 days after the study is completed in the EU/EEA.
End of trial - Global
When the study is completed globally the sponsor shall submit the notification within 15 days after the study is completed in both the EU/EAA and any third countries.
Summary of results
Irrespective of the outcome of a clinical study, the sponsor shall submit a summary of the results no later than one year after the study completed. For paediatric studies, the summary of results must be submitted within six months after the conclusion of the clinical study. 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, this must be done as soon as they become available. A later submission of results must be described and justified in the protocol, furthermore the protocol must specify the date when the summary will be available.
Clinical study report (CSR)
In cases where the clinical study is intended to be used for obtaining a marketing authorization for the medicinal product included in the study, the applicant must, in addition to the summary of results, submit a clinical study report. A clinical study report summarizes a single study of an investigational medicinal product (IMP), where clinical and statistical descriptions, presentations, and analyses are compiled and integrated. The clinical study report must be presented in an easily searchable format and prepared in accordance with the criteria outlined in Annex I, Part I, Module 5 of Directive 2001/83/EC. The report must be submitted within 30 days after the marketing authorization is approved, the authorization procedure is completed, or the application is withdrawn by the applicant.
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