Centralized Statistical Monitoring and Quality Tolerance Limits

Purpose

The CSM/QTL WG is a joint collaboration including ASA BIOP, PSI & EFSPI providing a forum to discuss strategies and methodology with other interested parties in Centralized Statistical Monitoring and Quality Tolerance Limits

Objectives

·         Facilitate sharing of case studies and experiences in this area

·         To recommend best practices and share new methodologies

·         To facilitate adoption of such methods by statisticians and non-statisticians to better serve future monitoring needs in clinical trials

 

For further information or to get involved in the CSM/QTL WG, please contact the co-chairs susan.talbot@amgen.com and timothy.e.rolfe@gsk.com