Data monitoring committees - Scientific guideline

This document deals with independent data monitoring committees. It highlights the key issues involved when sponsors include data monitoring committees as a part of their trial management.

Keywords: Safety monitoring, benefit/risk assessment, interim analysis, futility, type 1 error control, study integrity, study conduct

Current effective version

Guideline on data monitoring committees

AdoptedLegal effective date: 01/01/2006Reference Number: EMEA/CHMP/EWP/5872/03 Corr