Collaboration in CEC Strategies and Best Practices Roxana

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 2

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 3

Acknowledging Our Operational Differences Adjudication Format Facilitation Committee Qualification Voting Online Clinical Narratives Fellows Independent and Parallel with Tiebreaker In Person CRF/Source Documents Alone Board. Certified Physicians Group Consensus 4

Feasibility of Global Collaboration and Distributive Operations Organization • • 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 Implementation • Identify areas requiring process change at each organization • Implement process changes • Share progress Optimization • Share best strategies • Perform continuous evaluation of process improvement 5