Pharmacovigilance (PV) is the science relating to the detection, assessment, understanding and prevention of the adverse effects of medicines. Systems must be in place to enable the identification, recording, reporting and analysis of safety information so that any safety signals that arise during a trial are quickly identified and acted upon.

For Clinical Trials of Investigational Medicinal Products (CTIMPs), the sponsor’s responsibilities for PV are defined in Part 5 of the Medicines for Human Use (Clinical Trials) Regulations SI 2004 1031.

European Commission Detailed Guidance CT-3 2011 (PDF, 918 KB) defines the requirements for CTIMPs including the terminology associated with PV based on the assessment of seriousness, causality and expectedness of an adverse event.   A safety reporting flowchart (pdf, 180.98 KB) has been developed as part of the Toolkit to provide an overview of the assessments required.

Comprehensive guidance covering all aspects of PV for non-commercial trials (including when a risk adapted approach may be appropriate) can be found in the Joint Project Workstream Document: Pharmacovigilance (pdf).

The Investigational Site

For all trials, the investigator should make all staff aware of any safety reporting requirements and have systems to ensure all relevant events are detected, recorded and notified in accordance with the protocol (see Safety Reporting station).

Staff should be made aware of these requirements through GCP training and/or knowledge of local procedures or policies.

Further reading & Workstream Documents: