MHRA produced FAQs for Risk Adaptive Approach

[MHRA Super Moderator]

4. Is it expected that the trial is given an overall risk rating?

The MHRA scheme uses the Investigational Medicinal Product (IMP) marketing authorisation status to categorise into types A, B and C in relation to the authorisation process and potential documentation required for a trial. This categorisation is not equivalent to a risk rating, though it gives an indication that a trial of type C may involve more potential risks than one of type A. The real risk of the trial is obtained by an evaluation of the potential risks from conducting the trial, not just from the IMP marketing status ? this is why a full bespoke trial specific risk assessment is required. For example a trial may be assessed as type A based on the IMP status; however there may be other risks associated with the trial procedures and/or the use of a vulnerable population that would mean that it was not in fact a low risk trial. It is therefore recommended that a risk assessment process whereby an overall risk score for the trial is generated which leads to generic actions (e.g. a low score = no monitoring; high score = on site monitoring) is used with some caution. Whilst an overall risk score can give a useful indication of the trial?s risk, the aim of the risk-adapted approach is to identify specific vulnerabilities within the trial and take appropriate actions for these. Specific high risk areas within the trial could potentially be overlooked by assigning a risk category to the entire trial. Conversely, the risk assessment process can also identify areas where adaptations from ?traditional? GCP could be implemented, as no particular risk is identified, for example, no requirement to monitor storage conditions for the IMP.

Version 1: 01 March 2012