What Goes Into A Charter For DSMB Or Endpoint Adjudication?

By James Riddle, MCSE, CIP, CPIA, CRQM, VP of Research Services & Strategic Consulting; Barbara Schneider, PhD, MBA, Executive Director, Biostatistical Services

After 20 years of supporting clinical trial sponsors, the team at Advarra knows success depends on having a good committee charter. Independent data monitoring committees (DMCs/DSMBs) and endpoint adjudication committees (EACs/CECs) rely on the charter to set the course for project and the conduct of the committees. All of them have one thing in common: Success depends on having a good committee charter.

Where the clinical protocol outlines clinical trial operations and conduct details, the charter does the same to guide the operations and actions of the associated DMC and/or EAC supporting the trial. This blog looks at the key elements of a good charter and explores why these details are critically important to the successful completion of the research.