The notifications and reports which need to be sent to IMA are:
- Suspected unexpected serious adverse reactions SUSARs
- Other notifications (e.g. non-substantial amendments, protocol violations)
- Annual Report/Development Safety Update Report (DSUR)
- End of trial notification
- Final report
Documents should be sent electronically via CESP, USB flash drive or with an e-mail to the address [email protected] with the cover letter attached.
The cover letter must include the EudraCT number and a clear explanation of the content.
Annual Report/Development Safety Update Report (DSUR)
When a trial is conducted for longer than a year an Annual Report/DSUR shall be submitted to IMA which covers:
Risk/benefit analysis of the safety of participants in the trial
A line listing of all suspected serious adverse reactions (SAEs) (including SUSARs) occurring during the clinical trial, including serious adverse reactions from states outside the European Economic Area (EEA)
Summary in tabular form of suspected serious adverse reactions occurring during the trial
See further requirements on implementing the Annual Report in ”Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (Eudralex 10)”.
End of trial notification
Within 90 days from end of the trial a notification should be sent to IMA. A special form, Declaration of the End of Trial Form, should be attached to the notification.
A final report shall be sent to IMA no later than a year after the end of the trial. It shall contain a brief summary of major results and their assessment along with a summary of all adverse events.
Clinical trial results shall be provided in European Clinical Trials Database (EudraCT)
On the 21 July 2014, it was mandatory for sponsors to post clinical trial results in the European Clinical trials Database (EudraCT).
Sponsors will now be obliged to post results in EudraCT for any interventional trials registered in EudraCT and that have ended within a certain period of time:
- For any interventional clinical trials that ended on or after 21 July 2014, sponsors will have to post results within six or twelve months following the end of the trial, depending on the type of trial concerned;
- For trials that ended before that date, sponsors will need to submit the results retrospectively, in accordance with the specific timeframe laid out in the above-mentioned European Commission guideline on the posting and publication of result-related information on clinical trials.
EudraCT is pleased to announce a set of multimedia tutorials for clinical trial results is now available. These tutorials will aid sponsors in a step-by-step guide to provide results in EudraCT.
It is recommended to read the overview on the page before you download and use these tutorials.