Pharmacovigilance (PV) of authorised medicinal products is regulated by a series of regulations, directives, laws and guidelines. These rulings do not relate to pharmacovigilance of investigational (IMP) and non-investigational medicinal products (NIMP) used in clinical trials, which is not less obligatory. Instead, PV of clinical trials (CT) is an inherent albeit subordinate aspect of Good Clinical Practice (GCP).
Although relying on the (process) resources put in place by the sponsor for Eudravigilance (EV) reporting, CT-PV 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.
In consequence, some six years ago, ACPS initiated, validated and implemented SOPs pertinent to orderly PV of clinical trials. On writing these SOPs it became obvious that there was need to provide more background and explanation to the SOP-rulings in order facilitate their implementation and adherence. This resulted in a series of training modules on CT-PV and ultimately in an extensive CT-PV-Manual.
ACPS’ extensive Manual on Pharmacovigilance for Clinical Trials is available to you at no cost on request by E-mail (RE: “CT-PV Manual”).