GCP is an international ethical and scientific quality standard for the design, conduct and record of research involving humans. There are 13 principles of GCP (details of these can be found at http://ichgcp.net/ and compliance with GCP provides public assurance that the rights, safety and well-being of research subjects are protected and respected, in line with the principles enunciated in the Declaration of Helsinki and other internationally recognized ethical guidelines. It also ensures the integrity of research data.
Technically known as CH E6 Good Clinical Practice, the guideline was finalized in May 1996 by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The objective of harmonising the guideline was to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
When first expounded, GCP was internationally recognized as best practice, but was not enforceable by law. With the advent of the Medicines for Human Use (Clinical Trials) Regulations 2004 and the EU Directive on Good Clinical Practice, compliance with GCP is now a legal obligation in the UK and Europe for all trials of investigational medicinal products.
Researchers involved in studies that fall out of this category are also strongly advised to familiarize themselves with, and implement, the GCP principles.
Please note that the Department of Health's Research Governance Framework for Health and Social Care (version 2, April 2005), also aims to set standards in health research in the UK.