This white paper provides a detailed account of the operation of Clinical Endpoint Committees. It discusses how they are formed, how information is sent to members of the committee, how disagreements between committee members with regard to the confirmation of a suspected event are handled, and the latest developments in electronic adjudication processes.

 Authors:  

Catherine A. Tyner, MA MFA ABDSenior Director & Global Unit Head
Clinical Safety & Oversight Group
Solutions, Quintiles

Ransi M. Somaratne, MD MBA FACCMedical Director, Cardiovascular
& Endocrinology, Quintiles

Christopher H. Cabell, MD MHS FACCSenior Vice President & Global Head,
Therapeutic Delivery, Quintiles

J. Rick Turner, PhD, PGCE, MTOPRASenior Scientific Director, Cardiac
Safety Services, Quintiles