The use of Centralised Statistical Monitoring and Quality Tolerance Limits are fundamental components of Risk Based Quality Management as laid out in ICH-E6(R2) Good Clinical Practice. However, although there has been much commentary published on the operational application of Central Monitoring & QTLs, there appears to be a gap in the literature for the more detailed statistical methodologies that can be utilized.
The Central Statistical Monitoring / Quality Tolerance Limits - Special Interest Group (CSM SIG) has formed itself to create a forum to collaborate and discuss statistical strategies and methodology by;
- Sharing experiences
- Collate and summarise current knowledge by performing a literature review of related publications, white papers and regulatory guidance
- Develop & publish recommendations and best practices for the healthcare field leveraging learnings from other areas
If you’re interested in learning more &/or joining the CSM SIG please contact the SIG Co-chairs: Susan Talbot & Tim Rolfe.