1. What is the scheme that the MHRA have implemented?

The MHRA have implemented a dual strategy for a risk-adapted approach for clinical trials in the UK.

The first is a stratification approach into type A, B or C dependent upon the use of the investigational medicinal product (IMP) in relation to its marketing authorisation or an unlicensed IMP, i.e. the risks associated with the IMP. This would impact on the MHRA authorisation process, indicate potential changes to trial documentation requirements and inform the safety monitoring plan.

The second is a bespoke approach. This is a trial specific risk assessment to identify specific vulnerabilities in the trial conduct that could impact on the trial results and the protection of trial subjects? safety, rights and well being. This risk assessment would document the mitigations for specific identified risks and any adaptations from ?traditional? GCP. These would then be developed such that there would be risk proportionate management and monitoring of the trial.

For further details consult the MHRA website below:
http://www.mhra.gov.uk/home/groups/l.../con111784.pdf
Version 1: 01 March 2012