Webinar: RBQM – The AQC’s Risk-Based Monitoring Framework and Monitoring Plans Consistent with New FDA Draft Guidance
Wednesday, December 11, 2019 | 11:00am-12:00pm EST
With the advent of ICH E6 (R2) guidelines for Good Clinical Practice, the industry has been focusing on how to operationalize risk-based approaches for clinical trials.
To tackle these challenges, in 2019, the Avoca Quality Consortium (AQC) formed a Risk-Based Quality Management (RBQM) Leadership Advisory Board (LAB) that collaborated to develop leading practices to support the industry in applying RBQM within the function of clinical operations.
While the RBQM LAB targets both upstream RBQM practices (e.g., de-risking study designs/protocols) and downstream RBQM practices (e.g., capturing RBQM activities and outcomes in Clinical Study Reports), the most pressing needs as expressed by AQC Members was applying risk-based monitoring to clinical trials, particularly as it relates to guidance on developing a Risk Based Monitoring Plan (RBMP).
With the support of the RBQM LAB, the AQC has developed a collection of leading practice materials to support RBM consistent with the new (March 2019) FDA Draft Guidance, which includes the following:
- AQC terminology and definitions for 34 RBQM-related terms
- An AQC risk-based monitoring framework
- AQC guidance on development of a risk-based monitoring plan
- An AQC template for a Risk-Based Monitoring Plan
- AQC centralized monitoring procedural standards
In this webinar, Avoca will share highlights of these leading practices.
Who should attend:
- Clinical Operations Professionals
- Clinical Data Management Professionals
- Clinical Biostatistics Professionals
- Project Management Professionals
- Risk Management Professionals
- Quality Management Professionals
Senior Consultant, The Avoca Group
Need more information? Contact us with your questions or to schedule a consultation.