This guidance has been developed to assist those involved in clinical trials disrupted as a result of COVID-19. It is relevant to those involved with ongoing studies, those wishing to restart trials that have been paused or temporarily halted, and those wishing to start new studies.
In short, this guidance explains “How investigators and sponsors should manage clinical trials during COVID-19”
In an update to guidance on managing clinical trials during COVID-19, MHRA said the procedure for USM notifications has changed.
The rest of the guidance sets out what will happen during and after the call.
In order to determine whether the action taken is an Urgent Safety Measure (USM) please refer to section 3.9 and 3.10 (142-150) of guidance document CT-1.