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.