All clinical trials must adhere to Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for the design, conduct, recording and reporting of clinical trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that the clinical trial data and reported results of clinical investigations are credible and accurate.
The NIHR provide comprehensive GCP resources including templates and documents to help develop quality systems.
The new Medicines and Medical Devices Act 2021 requires compliance with GCP guidelines. Staff involved in any aspect of clinical trial work need to be suitably qualified to ensure that they comply with GCP. This also includes support departments.
There is no formal GCP qualification so it is essential for individuals to keep up to date records of their GCP education and training activity.
GCP training for University of Manchester employees can be obtained from: