# Risk-Adapted Approach to clinical trials and Risk Assessments

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/b78d7329-77ab-49e5-8255-1cdb571274d7
Type: Guidance
Published: January 28, 2022

> The UK Medicines and Healthcare products Regulatory Agency (MHRA) provides a strategic framework for implementing a risk-adapted approach to managing clinical trials involving Investigational Medicinal Products (IMPs). This guidance describes a two-part strategy designed to ensure participant safety and data integrity through proportionate oversight. The first component involves stratifying trials into three categories (Type A, B, or C) based on the marketing authorization status and inherent risks of the IMP. This classification determines the specific MHRA authorization requirements, documentation standards, and safety monitoring plans. The second component is a bespoke, trial-specific risk assessment aimed at identifying vulnerabilities in conduct that could jeopardize participant rights or trial results. Under this regulatory framework, sponsors are expected to document mitigations for identified risks and may adapt traditional Good Clinical Practice (GCP) standards to fit the trial's risk profile. While the document serves as general guidance rather than an inspection report for a specific company or date, it mandates that sponsors perform comprehensive risk evaluations to develop tailored management and monitoring strategies. These actions ensure that regulatory resources and oversight are effectively focused on the areas of highest risk within clinical research.

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## Content

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.

## Attachments

- [Risk-Adapted Approach to clinical trials and Risk Assessments](/government/publications/risk-adapted-approach-to-clinical-trials-and-risk-assessments/risk-adapted-approach-to-clinical-trials-and-risk-assessments)
- [Example 1: Type A Risk Assessment](https://assets.publishing.service.gov.uk/media/6221d6b18fa8f5490d52ef53/Example_1_Type_A_Risk_Assessment__1_.pdf)
- [Example 2: Type A Protocol Synopsis](https://assets.publishing.service.gov.uk/media/6221d6c3e90e0710ae791059/Example_2_Type_A_Protocol_Synopsis__1_.pdf)
- [Example 2: Type A Risk Assessment](https://assets.publishing.service.gov.uk/media/6221d7f08fa8f54915f438bd/Example_2_Type_A_Risk_Assessment.pdf)
- [Example 1: Type A Protocol Synopsis](https://assets.publishing.service.gov.uk/media/6221d69b8fa8f54912675250/Example_1_Type_A_Protocol_Synopsis__1_.pdf)
- [Example 3: Type A Protocol Synopsis](https://assets.publishing.service.gov.uk/media/6221d722e90e0710ae79105b/Example_3_Type_B_Protocol_Synopsis.pdf)
- [Example 3: Type A Risk Assessment](https://assets.publishing.service.gov.uk/media/6221d72de90e0710abe64a7c/Example_3_Type_B_Risk_Assessment__1_.pdf)