Data monitoring committees

Current effective version

PDF iconAdopted guideline

Reference numberCHMP/EWP/5872/03
Effective from01/01/2006
KeywordsSafety monitoring, benefit/risk assessment, interim analysis, futility, type 1 error control, study integrity, study conduct
DescriptionThis 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.

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