Introduction
Pharmacovigilance (PV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
PV is a regulatory requirement for any clinical trial of an investigational medicinal product (IMP) whether the trial is a first in man study of a novel drug or a study investigating how a well understood licensed drug performs in a real world setting.
In addition there are other types of study where vigilance processes are required for example:
Safety reporting is also a regulatory requirement for all clinical investigations of medical devices. Where a non CE marked device (or a CE marked device is used outside of its intended purpose) is used within an investigation there is a requirement to carry out vigilance.
Safety reporting is required within all studies involving human participants; even those that do not involve the use of drugs. Where an intervention or trial specific procedure takes place is important to ensure that the safety of the study in monitored.
About us
The Sponsor Pharmacovigilance Office is part of the Research and Innovation governance team. The Pharmacovigilance and Safety Manager is based within NHS GG&C while PV administration and systems are provided by the Robertson Centre for Biostatistics at the University of Glasgow.
We provide support to researchers from the grant stage of a study, to protocol development, identifying and managing risk from an IMP perspective, overseeing the collection and review of safety data, the processing and administration of Serious Adverse events, monitoring safety data for unexpected events, coding of events, and the preparation of Developmental Safety Update Reports. We ensure that all trials are compliant with the relevant regulatory frameworks on behalf of the lead investigator and Sponsor. The PV office has experience in oncology, cardiovascular, stroke, and many other fields of healthcare.
A risk adapted approach to pharmacovigilance and safety reporting is used to ensure that trials are conducted safely and efficiently while reducing the workload for both sites and investigators where possible.
The Sponsor PV office can help investigators for all studies, not just those involving drugs. We have experience of clinical investigations of medical devices, interventional studies, biomarker studies, and all other forms of healthcare research involving human subjects. We can help you at to assess the level of safety reporting required and aid in the preparation of study protocols. Please get in touch with the PV and Safety Manager should you wish to discuss any aspects of safety reporting.