Through a  mixture of lectures and workshops this course:

• Provides a history of clinical trials and the development of GCP
• Deciding what is a clinical trial as per EU Directive discussion of informed consent - the ethical and statutory imperatives with particular reference to vulnerable groups
• Responsibilities of research personnel and the process for obtaining approvals to conduct clinical trials
• Overview of the 14 principles of GCP
• Pharmacovigilance - definitions and a series of case studies are discussed

'Monitoring' exercise - group exercise to highlight examples of breaches of GCP and documentation discrepancies that can occur