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UK To Launch Notification Scheme For Low-Risk Trials

 
• By Vibha Sharma

The UK regulator’s new clinical trials notification scheme will allow researchers to proceed with low-risk studies without the need for further assessment. 

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UK wants to make it easier and faster for sponsors to gain clinical trial approvals • Source: Shutterstock

The UK’s medicines regulator, the MHRA, is readying a new notification scheme to allow the approval of low-risk clinical trials without the need for a full regulatory assessment. It is based on the principle of ensuring participant safety through risk proportionality.

The notification scheme will ensure that the participant risk is either equal to, or lower than, in standard clinical care, or takes account of information arising from the trial being...

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