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 […]
