Good Clinical Practice (GCP) training
Temporary change to training renewal requirements
It is a CUH requirement that all staff involved in clinical trials undertake good clinical practice (GCP) training every two years. However, in light of the difficulty scheduling refresher training during the ongoing pandemic, and in accordance with regulatory guidance, CUH is allowing flexibility with the two year renewal timeline.
If your GCP renewal was due between 01 March 2020 and 31 December 2021, the Trust will permit up to an additional 12 months for GCP refresher training to be undertaken, in order to aid scheduling between peak admission times.
Please note that it is expected that GCP refresher training is undertaken at the earliest opportunity during this period.
From 01 January 2022 the two-year renewal period will be reinstated. There is no change to the requirement for staff to have valid, certified GCP training prior to undertaking activities on a clinical trial.
It is Cambridge University Hospitals NHS Foundation Trust policy that all Research Nurses and all staff involved in clinical trials of investigational medicinal products (CTIMPs) complete GCP training. The Trust accepts certification of training done in the last two years.
The Trust has altered its GCP process in line with the current situation as they can no longer run face-to-face training; Epigeum has also introduced a new platform. See below for details.
Full sessions are now online via Epigeum or the NIHR:
- Epigeum – The access method for the online GCP training has changed. The platform you used previously to register is no longer active. You will now be set up directly by Aslihan Yener (firstname.lastname@example.org). Once set up, you will receive (i) a confirmation email from R&D with an attached User Guide and (ii) an automated email from Epigeum inviting you to complete your registration profile and activate your account. The course covers 5 modules. Each module has a test with a pass mark of 75%. A certificate is delivered at the end of each course:
- Course 1: Protocol and Associated Documents
- Course 2: Application, Agreements and Approvals
- Course 3: Trial Master Files
- Course 4: Conducting the trial
- Course 5: Safety Reporting
- NIHR – https://www.nihr.ac.uk/health-and-care-professionals/learning-and-support/good-clinical-practice.htm.
For refresher and lab sessions, a series of live webinars led by our trainer Shirley Hallam has now been set up. Dates are below. Each session will run for 2 hours from 09.00 to 11.00.
Refresher / lab sessions dates for 2021:
GCP update refresher:
- July 6th
- September 14th
- November 23rd
GCP for Laboratories
- Tuesday 20 April 2021
Certificates will be delivered at the end of the session or shortly after.
Once you have completed your course, please send a copy of the certificates to Aslihan Yener in R&D to ensure your training records are kept up-to-date.