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Good Clinical Practice (GCP)

Tripartite International Conference on Harmonisation (ICH) Good Clinical Practice (GCP)

GCP is an international ethical and scientific quality standard for the design, conduct and record of research involving humans. Compliance with this standard provides public assurance that the rights, safety and well being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki and that the clinical trial data are credible.

The objective of GCP is to provide a unified standard for the European Union (EU), Japan and the United States.

The GCP Directive 2005/28/EC was transposed into UK law under the Medicines for Human Use (Clinical Trials) Regulations 2004 Amendment Regulations 2006 (SI:1928).

ICH GCP E6 (R1) 1996- describes the responsibilities of all relevant individuals involved in the conduct of clinical trials including investigators, sponsors, monitors, regulatory authorities and ethics committees.  Full document at  http://www.ema.europa.eu/

The E6 Guideline contains 8 sections:

  • Glossary
  • Principles of ICH GCP
  • Institutional Review Boards (IRBs)/Independent Ethics Committee
  • Investigator Responsibilities
  • Sponsor Responsibilities
  • Protocol and Amendments
  • Investigator Brochure (IB)
  • Essential Documents

Compliance with GCP is a legal requirement and is mandatory for all CTIMPs. Non-complinace with GCP is punishable under UK Law.

Staff involved and conducting Clinical trials must have GCP training prior to commencing any applicable research activities. For details of how to obtain GCP training please got to the Training page.

 

Regulatory Framework documents for further information:

Trust R&D Policy can be downloaded form (see Policies in Document Library)

Research and Governance Framework:  NHS Research Governance Framework

Human tissue act 2004: http://www.hta.gov.uk/

Researchers should also be aware of the following general guidelines on good research practice:
Research: The Role and Responsibilities of Doctors, published by the General Medical Council
Good Research Practice, published by the Medical Research Council
and, for clinical trials:Guidelines for Good Clinical Practice in Clinical Trials, published by the Medical Research Council