title: Implementing a centralised pharmacovigilance service in a non-commercial setting in the United Kingdom.
abstract: The implementation of a pharmacovigilance service compliant with the legal and regulatory responsibilities of clinical trial sponsors presents particular challenges for sponsors in a non-commercial setting.In this paper we examine these challenges in detail. We identify and discuss the key steps in the development of a pharmacovigilance service within a public health service and university setting in the United Kingdom. We describe how we have established a central Pharmacovigilance Office with dedicated staff and resources within our organisation. This office is supported by an electronic pharmacovigilance reporting infrastructure developed to facilitate the receipt and processing of safety information, the onward reporting in compliance with legislation and the provision of sponsor institution oversight of clinical trial participant safety. An education and training programme has also been set up to ensure that all relevant staff in the organisation are fully aware of the pharmacovigilance service and are appropriately trained in its use.We discuss possible alternatives to this approach and why we consider our solution to be the most appropriate to ensure that a non-commercial sponsor organisation and investigators are operating in a fully compliant way.
authors.affiliation: Glasgow Clinical Trials Unit, Robertson Centre for Biostatistics, Boyd Orr Building, Glasgow G12 8QQ, UK. eleanor.dinnett@ggc.scot.nhs.uk
authors.forename: Eleanor M
authors.initials: EM
authors.lastname: Dinnett
authors.forename: Sharon
authors.initials: S
authors.lastname: Kean
authors.forename: Elizabeth P
authors.initials: EP
authors.lastname: Tolmie
authors.forename: Elizabeth S
authors.initials: ES
authors.lastname: Ronald
authors.forename: Allan
authors.initials: A
authors.lastname: Gaw
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence / Q000458:organization & administration; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D003299:Cooperative Behavior; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions; D033161:Government Regulation; D006291:Health Policy; D006801:Humans; D007318:Inservice Training; D033183:Interdisciplinary Communication; D009937:Organizational Objectives; D060735:Pharmacovigilance; D016730:Program Development; D017150:Public Sector / Q000331:legislation & jurisprudence / Q000458:organization & administration; D013222:State Medicine / Q000331:legislation & jurisprudence / Q000458:organization & administration; D006113:United Kingdom; D014495:Universities / Q000331:legislation & jurisprudence / Q000458:organization & administration; D057188:Workflow