Pharmacovigilance (PV) for clinical trials (CT) is the duty and responsibility of the sponsor and investigator to
i) ensure a continuous surveillance of the benefit:risk-relationship of the interventional exposure of the trial participants to investigational medicinal products and
ii) to inform the competent authorities, ethics committees and investigators of any relevant unfavourable change of this relationship as might become apparent in consequence of the trial.
In the EU/EEA and the EU Member States (MS), PV of investigational medicinal products (IMP) and auxiliary products (AuxMP) in clinical trials irrespective of their regulatory status (authorised or not) is an inherent albeit subordinate aspect of Good Clinical Practice (GCP). Thus, PV of clinical trials is subject to the international and national regulations on the orderly conduct of clinical trials and GCP-compliance.