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Clinical Trial Regulations

Medicines for Human Use (Clinical Trials) regulations 2004

Clinical trials conducted to GCP, ultimately shown in Randomised Controlled Trials, offer the gold standard for determining if a remedy or investigation really offers a benefit. They fundamentally require that the research is unbiased. The International Conference on Harmonization [ICH] for Good Clinical Practice [GCP] established the need to make trials auditable with rigorous vetting of protocols and clear requirements to follow these protocols. The guidelines also established a chain of responsibilities leading from the researcher all the way up to the sponsor. EU Directives were formulated in 2001 (2001/20/EC) and 2005 (2005/28/EC) to allow for enforcement of GCP guidelines. These were passed into UK law as statutory instruments (SI) 1031, 1928, 2984 and 2031. Enforcement of the statutes in the UK is delegated to the Medicines and Healthcare Products Regulatory Agency (MHRA). Guidance for the maintenance of regulatory compliance in laboratories that perform the analysis and evaluation of samples from clinical trials were published by the MHRA in July of 2009. The EU directives and UK statutory instruments will be replaced by new EU clinical trial regulations in 2016.