Pharmacovigilance (PV) for clinical trials (CT) is the duty and responsibility of the sponsor and investigator to ensure a continuous surveillance of the benefit:risk-relationship of the interventional exposure of the trial participants to investigational medicinal products and 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, the European Economic Area (EEA) and the EU Member States (MS), PV of investigational medicinal products (IMP) and non-investigational products (NIMP) in CTs irrespective of their regulatory status (authorised or not) is an inherent albeit subordinate aspect of good clinical practice (GCP). Therefore PV of CTs is subject to the international and national regulations on the orderly conduct of CTs and GCP compliance.
Although relying on the process resources put in place by the sponsor for Eudravigilance reporting, PV of CTs requires its own GCP-compliant trial specific provisions, including risk-based PV-quality management, review of the safety reference information in the investigator brochure, review of the PV-information and instructions in the CT protocol, investigator training and instruction, on-study capture and analysis of safety signals, expert review of serious adverse events (SAE), and expedited handling of SAE and serious unexpected serious adverse reaction (SUSAR) reports.
Relying on more than twenty years of planning, conducting and reporting CTs, ACPS has developed several high-level tools for orderly GCP compliant PV of CTs. Have a look at ACPS‘ PV manual for CTs that is available in the ACPS-Library.
In addition, ACPS provides dedicated customised services for the set-up, management and reporting of orderly GCP compliant PV of your CT in EU.
Based on more than three decades of hands-on experience in early CTs, ACPS has developed dedicated expertise and resources on-trial safety surveillance.