Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve people.
Guidance on good clinical practice has been produced by the International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH).
Both the HRA and the Medicines and Healthcare products Regulatory Agency (MHRA) advocate a proportionate approach to the application of GCP to the conduct of clinical trials and the appropriate training of staff involved, including those seeking consent from potential participants. Our joint statement clarifies the legal requirements for training in Good Clinical Practice (GCP) in the UK.
The International Conference on Harmonisation GCP Guideline (ICH GCP) (as adopted by the Committee for Medicinal Products for Human Use (CHMP) is part of European guidance, as an element of EudraLex Volume 10, and as such should be taken into consideration, where appropriate, as an established standard for GCP. In particular, if a study involving investigational medicinal products is to be included as part of a marketing authorisation application then it is an expectation that ICH GCP should be complied with, and this is referred to in the annexes to the Notice to Applicants (Volume 2B) for the Common Technical Document.
Sponsors of CTIMPs which are not to be included as part of a marketing authorisation application, can choose to comply with ICH GCP as a standard in its entirety or they can take a more proportionate approach and depending on the nature of the trial. Further information about this can be found in the MHRA guidance on risk adapted approaches in the management of CTIMPS.
Non-commercial, low risk (as defined by the MHRA) CTIMPs are required to follow the principles based on ICH-GCP but are not obliged to comply with full ICH-GCP unless they propose to do so.
For clinical investigations of medical devices, the standard EN ISO 14155, which outlines good clinical practice, may be followed.
It should be noted that there is no legal requirement for other types of research (i.e. studies which are not clinical trials of investigational medicinal products) to be conducted in accordance with the conditions and principles of GCP. However, it is still important that such research is always conducted in a manner that provides public assurance that the rights, safety and wellbeing of research participants are protected and that research data are reliable. Members of the research team in such studies are expected to be qualified by education, training or experience but should not be required or expected to undertake GCP training.
Other helpful resources
- The Medicines for Human Use (Clinical Trials) Regulations 2004 gives details of legal requirements for Good Clinical Practice in relation to clinical trials in the UK
- MHRA Good Clinical Practice: guidance and inspections
- Guidance On Good Clinical Practice International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline for Good Clinical Practice (‘ICH GCP’) 10/06/96