Closing studies at EC Research

What needs to be submitted?

Cover letter with the following information:

  • What exactly is reported: closing of inclusion of subjects (at local level or in all participating centres), last visit of last patient (at local level or in all participating centres), closure of a centre as a research centre after all data have been collected and checked, etc.
  • Whether or not the study is terminated prematurely (with specification of reasons if premature).

Please provide a Clinical Study Report containing a summary of the results to the EC within one year of termination of the study. When closing a study with an EudraCT number, please provide us with an additional Annex III form (End of trial form).

According to the Act of 7 May 2004

The sponsor notifies the end of the trial to EC Research:

Act of 7 May 2004, Art. 21

§ 1. The sponsor shall inform the competent ethics committee in case of a monocentric experiment and the ethics committee competent for the single opinion in case of a multicentric experiment about the end of the experiment and this within a period of 90 days  after the end of the experiment.  [..]

§ 2. The 90-day period shall be reduced to 15 days if the experiment has to be terminated prematurely. The notification must clearly specify the reasons for the premature termination.

Last edit: 24 February 2023