Clinical Events Committee

YCRG offers Clinical Events Committee (CEC) organization and implementation to enable the independent adjudication of clinical events, conforming to regulatory requirements within single or multi-center, national or international clinical trials.

Role of the CEC in Clinical Trials

The CEC is an independent committee of medical experts formed to review specific information obtained from research subjects who are participating in a clinical trial. Its primary role is to provide an independent expert review of data on clinical events based on protocol-specific definitions.

The CEC review ensures that events critical to the analysis of study results are assessed in a uniform manner, eliminating the variability associated with site-based event evaluation. This facilitates reliable pooling of data within a trial and with predicate trials, and improves the validity of comparisons with published data.

In addition to study endpoints, the CEC can provide assessment of other events or areas of concern at the request of the DSMB or Sponsor (e.g., device malfunction or failure, anticipated versus unanticipated adverse events).

CEC Composition

Each YCRG-convened CEC is composed of a group of independent medical experts with experience and expertise in the therapeutic area of study, the patient population being studied, and the conduct of clinical trials.

Member selection is carefully conducted to ensure:

• Balanced composition;
  
• Relevant expertise;
  
• Complete independence from the Sponsor and conduct of the trial;
  
• Evaluation and documentation of any Conflict of Interest; and
  
• Commitment to flexible schedules for the duration of the project life cycle.

YCRG has access to experienced trialists who are familiar with contemporary scales and definitions common to a variety of drug and device clinical trials. YCRG's pool of CEC candidates has medical expertise in the full spectrum of cardiovascular disease and treatment.

CEC Management

YCRG CEC management assures thorough documentation of the event, the review process, and the results of all CEC evaluations. We work with the sponsor and other CROs or data management partners to:

• Manage work flow and processes for all aspects of CEC adjudication;
  
• Define SD requirements and provide feedback regarding any deficiencies or discrepancies between SDs and CRFs;
  
• Ensure consistency in application and consideration of definitions over time and by all CEC members;
• Facilitate and help define any questions relative to individual events and surrounding circumstances (co-morbidities, evidential proof, etc.);
  
• Facilitate review of all physiological data available in a single setting;
  
• Reconcile all adverse events for endpoint criteria, completed adjudication, database entry, and against clinical database event entries;
  
• Track and archive SD records and study media;
  
• Manage translation processes; and
  
• Integrate activities with Project Management/Study Team/Core Labs to achieve study milestones in cost effective manner.