What is GCP?

"Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting 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, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible."

                    ICH Guideline for Good Clinical Practice E6 (R1)

Brief History

ICH GCP replaced previous European Community GCP Guidelines and was adopted by the CPMP (CPMP/ICH/135/95)  in  July 1996. It became operational in the European Union (EU) in January 1997 but was not enforced by law.

In 2001 the  EU Clinical Trials Directive 2001/20/EC, referred to as the Clinical Trials Directive, was published. This then had to be transposed into law by each of the member states. In the UK, the statutory instrument implementing the Clinical Trials Directive is the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004 No 1031). This came into force on 1 May 2004 and compliance with GCP became a legal requirement for all clinical trials of investigational medicinal products.

In 2005 the EU GCP Directive 2005/28/EC, known as the GCP Directive, set out the principles and conditions of Good Clinical Practice that apply to all clinicial trials today and this is implemented in the UK through the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (SI 2006 No 1928).