Glasgow Clinical Trials Unit, Robertson Centre for Biostatistics, Boyd Orr Building, Glasgow G12 8QQ, UK.
Trials. 2013 Jun 12;14:171. doi: 10.1186/1745-6215-14-171.
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.
实施符合临床试验申办者法律和监管责任的药物警戒服务，对非商业环境中的申办者提出了特殊挑战。本文详细探讨了这些挑战。我们确定并讨论了在英国公共卫生服务和大学环境中开发药物警戒服务的关键步骤。我们描述了如何在我们的组织内建立一个中央药物警戒办公室，配备专门的工作人员和资源。该办公室得到了一个电子药物警戒报告基础设施的支持，该基础设施旨在方便接收和处理安全信息，按照法规进行报告，并提供申办机构对临床试验参与者安全的监督。还设立了一个教育和培训方案，以确保组织内所有相关工作人员都充分了解药物警戒服务，并接受其使用的适当培训。我们讨论了这种方法的其他可能替代方案，以及为什么我们认为我们的解决方案是最适合确保非商业赞助商组织和研究者以完全合规的方式运作的。
