EC creates rules for members involved in assessing safety in trials

13 January 2022

The European Commission (EC) has set out the rules for the cooperation of member states in safety assessments in clinical trials.

While most responsibility lies with the sponsor in ensuring participants’ safety in trials, additional oversight is also required from member states.

The implementing regulation set out by the EC details the process for picking a member state to assess information on suspected unexpected serious adverse reactions and describes their role in screening for safety signals in clinical trials.

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