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Tag: data monitoring committee

Clinical Research: Phase 1 - Phase 4

DMC? CEC? Your Guide to Translating Clinical Trial Shorthand

We were reviewing a study protocol for a maker of medical devices, and there was one provision that just didn’t make sense. The sponsor specified a need for regular data monitoring committee meetings, but we didn’t see the need and couldn’t justify the effort. It was a short study involving few sites. In all likelihood,...

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Data Management & Biostatistics

Demystifying the Differences Between DMCs and CECs

In a clinical trial landscape where global, multi-center studies have become increasingly common, trial monitoring has become more complex. Regulations require that sponsors of medical device studies perform site monitoring to ensure that investigators are compliant with federal regulations, sponsor agreements, the investigational plan and the requirements set forth in the Investigational Review Board (IRB)...

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