The initiative aims to successfully establish clinical trials safety monitoring in the European Union (EU).
To support these activities, ACT EU will focus on training for safety assessors, with the development of a curriculum to harmonise expertise.
It will also enable the implementation of the ICH E19 guideline on selective safety data collection.
Joint Action (JA) 12 of the EU4Health Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials (SAFE CT) supports these new concepts through provision of additional resources and expertise necessary to implement the new regulation.
The goal of this JA is to establish and maintain cooperation in safety data assessment in clinical trials via building capacities and performing training activities in the participating Member States. The experience gained during the JA will be used to update and improve the procedures on cooperation and training in safety surveillance in clinical trials.