Data Safety Monitoring Boards
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FDA Guidance for Industry
ABSTRACT: "This guidance discusses the roles, responsibilities and operating procedures of Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards (DSMBs) [...]"
EMA Committee for Medicinal products for human use (CHMP)
ABSTRACT: This Guideline document deals with independent Data Monitoring Committees. It is intended as an overview guide to highlight the key issues involved when sponsors include data monitoring committees as [...].