The UK medicines regulator says it expects to see a rise in protocol-related deviations in ongoing clinical trials as a result of disruptions caused by the COVID-19 outbreak, which the World Health Organization declared a pandemic on 11 March.
The Medicines and Healthcare products Regulatory Agency has clarified that any increase in protocol deviations in relation to coronavirus “will not constitute a serious breach” and should not be reported to the agency, unless there is a risk to patients
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