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Clinical Events Classification

The Clinical Events Classification group at the DCRI is a unique body of expert researchers involved in all phases of our trials. Early involvement of the CEC group creates more efficient research through clearly defined responsibilities and speedy endpoint adjudication. The results for our sponsors are faster interim and final analyses, and rock-solid adjudication by physician-investigators with decades of experience.

The DCRI CEC group is one of the first of its kind in the world, performing independent and unbiased event adjudication as integral to the data collection and management process. The CEC group’s experience is both broad and deep, covering many therapeutic areas and studies of all sizes. This includes vast regulatory experience both in the U.S. and abroad. It offers services unmatched by any other academic research organization:

CEC experts work closely with both trial personnel and sponsors at all stages in a clinical trial, providing guidance on everything from case report form design to creating trial-specific databases and event-identification processes that are tailored for an individual project’s needs.

Our CEC personnel are also focused on clinical trial methodology, constantly searching for better, more efficient ways to track and evaluate endpoint events and provide impeccable data quickly. CEC experience is being turned into innovation every day at the DCRI.

Leader: Kenneth Mahaffey, MD

Contact: Freda Wood

   

• Development of endpoint definitions
• Development of case report form pages for endpoint events
• Development of adjudication forms for endpoint results
• Processing/event packet preparation
• Collection of source documents from sites
• Development of tracking databases and status reports
• Data entry of endpoint results in validated databases
• Clinician service for event adjudication

 

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