Collaboration in CEC: Strategies and Best Practices Roxana Mehran, MD September 27, 2018

A Case for Global CEC Collaboration and Harmonization Share, implement, optimize and innovate strategies based on existing best practices Minimize adjudication outcome variabilities among research organizations Collectively enhance the quality and validity of endpoint assessment

Building off Known Best Practices Standardized Definitions Uniform SOP Comprehensive CEC Charter Complete Event Ascertainment Collaboration with Monitors and Data Management Dedicated CEC Support Staff Qualified, Independent Adjudicators Prospective, Timely, Consistent Adjudication Quality Control and Assurance

Acknowledging Our Operational Differences Adjudication Format Online In Person Facilitation Clinical Narratives CRF/Source Documents Alone Committee Qualification Fellows Board-Certified Physicians Voting Independent and Parallel with Tiebreaker Group Consensus

Feasibility of Global Collaboration and Distributive Operations Form an executive CEC task force Identify known gaps and differences in CEC operations Gain consensus for uniform adjudication practices Plan implementation strategies with goals Organization Identify areas requiring process change at each organization Implement process changes Share progress Implementation Share best strategies Perform continuous evaluation of process improvement Optimization