Clinical Events Committee

Overview

The CEC provides an independent, blinded determination of trial endpoints or events, a critical factor in the acceptance of trial results by regulatory authorities, academic leaders and medical communities.

Clinical Events Committee Process

Experienced CEC Project Managers, along with the CEC Director Venu Menon, MD and Associate Director Vidyasagar Kalahasti, MD, oversee each study tailoring the CEC process to study-specific needs. Our CEC Project Managers are all experienced Registered Nurses.

The CEC process includes:

• Protocol input and/or review
• Process development that allows for ongoing/timely adjudication
• CEC Charter development, including endpoint definitions
• Identifying MedDRA terms or AE terms for event identification
• Development of training materials
• Adjudicator training
• Electronic Adjudication System (EAS) workflow development
• Customized quality assurance plans per trial

The CEC has performed endpoint adjudication since 1994. Our extensive experience includes adjudicating adult and pediatric cardiovascular and neurologic events in multi-center, international, device and pharmaceutical trials of diverse sizes and characteristics. Event types include:

• Death
• Cardiac ischemia
• Heart Failure
• Coronary and Peripheral Revascularization
• Valvular Dysfunction
• Bleeding 
• Vascular Complications
• Stroke/TIA
• Arrhythmia/Conduction Disturbances
• Gastrointestinal 
• Hypertension
• Syncope
• Acute Kidney Injury
• Liver Injury
• Rash
• Pancreatitis
• Fractures

Clinical Events Committee Experience