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MHRA Advice for Management of Clinical trials in relation to Coronavirus

The Medicines and Healthcare products Regulatory Agency (MHRA) are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials. Patients may be advised to stay away from hospitals and GP sites due to existing health problems that may put them at risk of infection, or they may be reluctant to travel to sites where there are high densities of people. They may also have been advised to self-isolate as a precaution or as a result of confirmed infection so are unable to undertake required clinical trial activities. Organisations managing and sponsoring clinical trials are also experiencing a higher proportion of staff working from home during this period.

This has led to reports of protocol and standard operating procedure deviations due to missed visits, or changes in processes, for example posting out drug to patients. Wet-ink signatures have also been difficult to obtain in a timely manner if staff are not in the office, and this can delay some clinical trial processes.

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