New instructions define more precisely the process for the notification of serious and unexpected adverse reactions in clinical trials.
The Spanish Agency of Medicines and Medical Devices (AEMPS) has recently published an update to the existing instructions for conducting clinical trials in Spain. Specifically, in Annex II entitled ‘Safety documentation that the promoter must send to the health authorities of the Autonomous Communities’, details are provided on where reports on serious and unexpected adverse reactions (RAGI) should be directed and whether or not there is a need to prepare an update to the drug safety update report (DSUR) or to an ‘ad hoc report on urgent safety measures’.
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