Notice: This guidance is being revised by the FDA, comments can be submitted by April 15th, 2024. The draft revision is available here.
ABSTRACT: "This guidance provides recommendations to help sponsors of clinical trials determine when a data monitoring committee (DMC) [...] would be useful for trial monitoring and what procedures and practices should be considered to guide their operation [...]"

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 [...].