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 non-investigational products (NIMP) in clinical trials irrespective of their regulatory status (authorised or not) is an inherent albeit subordinate aspect of Good Clinical Practice (GCP). Therefore PV of clinical trials is subject to the international and national regulations on the orderly conduct of clinical trials and GCP-compliance.
Although relying on the (process) resources put in place by the sponsor for Eudravigilance reporting, PV of clinical trials requires its own GCP-compliant trial specific provisions: risk-based PV-Quality Management, review of the Safety Reference Information in the Investigator Brochure, review of the PV-information and -instructions in the Clinical Trial Protocol, Investigator Training and Instruction, on-study capture and analysis of safety signals, expert review of SAE-reports, expedited handling of SAE/SUSAR-reports, etc.