Clinical Trial Services

Clinical Events Committee (CEC) adjudication is critical to ensuring the generation and recording of quality data in a clinical trial. The CEC provides medical review and adjudication of trial-specific endpoint events.

HCRI offers CEC services in a variety of therapeutic areas and may be contracted as part of a complete trial management package, or as a stand-alone engagement.  The uniqueness of HCRI’s formal CEC meeting format allows for vigorous discussion and superior adjudication of endpoint events.

HCRI’s CEC members are Board-certified physicians from the Boston area teaching hospitals who meet on a regular basis to review clinical events and provide adjudications utilizing trial-specific definitions.  Each trial is assigned a Clinical Reviewer, either an experienced Registered Nurse or a physician, to assemble the data required for comprehensive analysis and adjudication.  In addition to event adjudication, CEC services include:

• Development of the CEC manual of procedures (MOP)
• Participation in the development of case report forms (CRFs)
• Participation in the pre-programming review of edit checks
• Identification of reported and suspected endpoint events
• Preparation of report-quality clinical narrative summaries which may be used as a supplement to regulatory reports and to DSMB or Data Monitoring Committee (DMC) reports.
• Delivery of CEC meeting minutes