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Simplified reporting procedures for monitoring the safety of clinical trials: simplified procedures for sponsors

From 22 May 2023, clinical trial sponsors will be subject to new, simplified procedures for declaring the vigilance of the medicinal products tested, in accordance with the Jardé law. The changes are as follows:

Reporting of Suspected Unexpected Serious Adverse Reaction (SUSAR): from now on, these incidents must be transmitted exclusively electronically to the European Eudravigilance database. Simultaneous reporting to the French National Agency for the Safety of Medicines and Health Products (ANSM) is no longer required, except for clinical trials conducted in France on healthy volunteers. In the latter case, the procedures for reporting to the ANSM via and to Eudravigilance remain unchanged.

Annual Safety Report (ASR) or Development Safety Update Report (DSUR) for clinical trials under the Jardé Law: these reports must be submitted using a simplified form.

The aim of these new procedures is to simplify the process for reporting clinical trial vigilance data.

For more information on clinical trial vigilance, please consult the following link: Click