Clinical Trials Training

Statutory Instrument 2004/1031 – the Medicines for Human Use (Clinical Trials) Regulations 2004 transposed the European Union Directive 2001/20/EC for Clinical Trials into UK law effective from the 1st May 2004. The original UK regulations were amended in August 2006 to incorporate the EU GCP Directive (2005/28/EC) as Statutory Instrument 2006/1928.

The Regulations state that Clinical Trials involving medicinal products MUST be authorised by the MHRA and conducted according to the Principles of GCP as defined in the Regulations and any subsequent amendments.

MHRA GCP Inspectors assess compliance with the requirements of GCP by conducting inspections at the sites of pharmaceutical sponsor companies, contract research organisations, academic research organisations, investigational trial sites, clinical laboratories, GCP archives and other facilities involved in clinical trial research. Mandatory GCP inspections will be conducted in both commercial and non-commercial organisations within the UK.

Schedule 1 Part 2 of the regulations defines the 16 Principles of GCP, number 8 states: - “Each individual involved in conducting a trial shall be qualified by education, training, and experience to perform his or her respective task(s)”

The Kings Health Partners CTO will provide mandatory clinical trials training to Partner Organisations employees and any other staff involved in clinical trials sponsored, co-sponsored or hosted by the Partner Organisations.

SOP: Clinical Trials Training (8MB)

Related Documentation

Related Information