Guidance on GCP training

Studies requiring GCP training

Notes:

  1. A certificate confirming GCP training must be supplied to R&D and a copy kept for your records
  2. For all other studies the Trust recommends that GCP training is undertaken
  3. GCP training must be renewed every two years

To find out about when GCP courses will be taking place please contact:

  • For adopted studies: Jetta Holmes () and Penny Scardifield ()
  • For non-adopted studies: Kate Horton ()

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human subjects. Conducting clinical trials to these standards ensures that the rights, safety and well-being of subjects are protected and that the clinical trial data are of the highest quality and credible.

Through the introduction of the European Clinical Trials Directives (2001/20/EC and 2005/28/EC) ICH-GCP has been standardised throughout Europe and in the UK these directives became law from 2004 (Medicines for Human Use (Clinical Trial) Regulations 2004).

For further information on these Regulations,
GCP training is mandatory for any investigator or research team member involved in trials using an investigational medicinal product or medical device.