Guidance

Risk-Adapted Approach to clinical trials and Risk Assessments

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

Documents

Example 1: Type A Protocol Synopsis

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Example 1: Type A Risk Assessment

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Example 2: Type A Protocol Synopsis

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Example 2: Type A Risk Assessment

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Example 3: Type A Protocol Synopsis

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Example 3: Type A Risk Assessment

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Details

The first part of the strategy is the stratification of trials 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 part 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 participants safety, rights and wellbeing. 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.

The following guidance looks to elaborate on some of ways in which to implement a risk-adapted approach to clinical trials and provides some worked examples. Find more information at Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products and the topic is also explored in one of our blog posts published in 2017.

Published 28 January 2022