MHRA Guidelines on Managing Clinical Trials during COVID-19

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The MHRA will be as flexible and pragmatic as possible with regard to regulatory requirements for clinical trials during this time. They recognise that clinical trial resource may be absent or redeployed from research activities and regulatory affairs towards front-line care.

This guidance advises those involved in clinical trails on specific issues which may arise as a result of COVID-19, and what they are required to do. It includes guidance on remote monitoring for trials, example letters, and protocol waivers. 

The first priority should be the safety of trial participants and this will remain their focus.

This guidance will be updated as the situation changes over time.

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