The course covers the key issues necessary to ensure that clinical trials comply with the standards of good clinical practice, in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments.
It is in line with national developments in research systems and has both Royal College of Physicians accreditation and TransCelerate endorsement, a standard generally recognised by industry sponsors.
The full GCP course is highly interactive, including a wide variety of exercises, illustrative video dramas and interviews. It is made up of five modules.
Each module is assessed by 20 randomly generated questions.
A revalidation assessment is available for researchers who currently work in clinical research and wish to revalidate their understanding of GCP.
Assessment is through quizzes covering the five course modules.
Course overview and registration
- Protocol and associated documents
- Applications, agreements and approvals
- Trial Master Files
- Conducting the trial
- Safety reporting
The full course and refresher course are available free of charge to anyone involved in clinical trials sponsored or hosted by either the University of Oxford or Oxford University Hospitals NHS Foundation Trust (OUH). This access applies wherever in the world an individual is located.
Complete the online registration form and once eligibility has been established, a username and password will be issued for access to the course. Please note that it can take up to 48 hours for access details to be sent to you.