Online Program

Return to main conference page
Thursday, September 13
Thu, Sep 13, 11:45 AM - 1:00 PM
Various Rooms
Roundtable Discussions

TL35: TOWN HALL - ICH E6 Addendum: Quality Tolerance Limits and Statistical Analyses of Accumulating Data to Facilitate Centralized Monitoring (300774)

*Qais Hatim, FDA 
*Rakhi Kilaru, PPD 
*Charles Lawrence Liss, CSL Behring 
*Paul H Schuette, FDA/CDER 
*William Wang, Merck & Co. 

The concept of predefined quality tolerance limits (QTL) have been introduced in the revised International Council for Harmonization (ICH) Guideline for Good Clinical Practice (GCP) E6 (R2) to identify systematic issues that can impact subject safety or reliability of trial results. The addendum suggests developing a systematic, prioritized, risk-based approach to monitoring clinical trials. The regulatory guidance for industry released in March 2018 re-iterated recommendations made in GCP addendum to better manage study risks.

Certain events in a study will occur that may impact interpretation of key efficacy or safety endpoints. Establishing appropriate QTLs can help identify and mitigate the frequency and extent of such event occurrences early by ensuring mitigation steps are put in place earlier to avoid the risk of key study-level parameters or events exceeding the established tolerance limits at the end of the study.

Quality tolerance limits combined with centralized statistical monitoring (CSM) can supplement risk-based monitoring approaches through proactive detection of risks such as inconsistent data, data outliers, unexpected lack of variability and protocol deviations.

In this session, we plan to discuss the following as a town hall style panel followed by an open discussion with prompts: 1) QTL process and definitions 2) KRIs 3) Examples 4) Open discussion on QTLs and Centralized Statistical Monitoring: Polling prompts

Planning on two panelists from industry and two from FDA