Gene Therapy Advisory Committee (GTAC)The Gene Therapy Advisory Committee is the national ethics committee for clinical trials involving medicinal products for gene therapy under Regulation 14(5).
General Data Protection Regulation (GDPR)
GDPR refers to requirements in both the EU General Data Protection Regulation and the UK Data Protection Act 2018 (ratified 23 May 2018). The HRA website defines key terms in the legislation.
GeneralisabilityThe extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings.
Good Clinical Practice (GCP)Good Clinical Practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
Good Manufacturing Practice (GMP)Good Manufacturing Practice (GMP) is that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation (MA) or product specification.
Governance Arrangements for Research Ethics Committees (GAfREC)
A policy document has been written by the UK Health Departments describing what is expected from the research ethics committees that review research proposals relating to areas of the UK Health Department's responsibility. It also explains when review by these committees is required. It can be downloaded from the Department of Health’s Publications Policy and Guidance web page.