What is a DMC?

A Data Monitoring Committee (DMC) is an independent group of experts, who monitor un-blinded safety and efficacy data while a trial is ongoing.

A DMC is typically allowed to be un-blinded and is evaluating mainly safety results (AE, SAE, safety laboratory parameters) on a regular basis.

The DMC recommends to the Sponsor either to continue the trial, stop the trial or put the trial on hold and modify the trial.

Both FDA and EMEA have issued guidelines about DMCs and their roles and responsibilities.

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