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

2. 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

3. 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

4. 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

5. 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