Data monitoring committees - Scientific guideline
Table of contents
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
- Biostatistics
- Directive 2001/20/EC
- ICH E3 Structure and content of clinical study reports - Scientific guideline
- ICH E6 (R2) Good clinical practice - Scientific guideline
- ICH E9 statistical principles for clinical trials - Scientific guideline
Draft questions and answers on Data Monitoring Committees issues