Implementation of a centralized pharmacovigilance system in academic pan‐European clinical trials: Experience from EU‐Response and conect4children consortia

Clinical studies involve an increasing amount of data collection and management. However, there is no specific quality standard sufficiently practical, in free access, and open for data management and the underlying IT-infrastructure in academic units. European Clinical Research Infrastructures Network (ECRIN) published standard requirements for certified data management units. We present a French version of these standards. The revised version includes 21 lists of five to ten standards, in three groups: information technologies, data management (DM) and "general".