Welsh Government

Standard Operating Procedures

Standard Operating Procedure 1 - SOP on SOPs (pdf)

Standard Operating Procedure 2 - SOP on GCP (pdf)

Both the Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) advocate a proportionate approach to the application of GCP and the appropriate training of staff involved in clinical trials and as such, have released a joint HRA/MHRA statement on the Application of Good Clinical Practice Training for Researchers (v1.1 October 2017) to clarify requirements for GCP training. This has been endorsed by all four UK nations and is reflected within this SOP.

Its purpose is to outline an all-Wales approach to adopt the UK guidelines advocating appropriate and proportionate requirements for Good Clinical Practice (GCP) training to ensure the research workforce is appropriately qualified, trained and experienced to conduct studies competently, in accordance with their study role and in compliance with UK research governance and applicable legislation.