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Clinical Events Classification

The Clinical Events Classification group at the DCRI works with both sponsors and clinical leadership at all stages in a clinical trial to tailor the event-identification process for an individual project’s needs.

The CEC group performs independent and unbiased event adjudication as an integral part of the overall data management, site management, and statistical activities for a clinical trial.

Our CEC experience includes work on Phase II–IV clinical trials in multiple countries and has included almost 200,000 patients with more than 100,000 events adjudicated.

The CEC incorporates innovative strategies and ideas, including integrated CEC and data management processes, so that adjudicated endpoint data are available on time for the DSMB, database lock, and other important timelines throughout a trial.

Our faculty and RN clinical trials coordinators have experience in multiple therapeutic areas including:

  • Endocrinology
  • Orthopedics
  • Cardiology
  • Surgery
  • Neurology
  • Nephrology
  • Oncology
  • Investigational devices
  • Infectious diseases
  • Gastroenterology
  • Peripheral vascular disease
  • Geriatrics
  • Women's health
   

Services

Comprehensive services for the development of highly efficient event adjudication programs include:

  • Expertise in CEC processes, including EDC and paper-based trials
  • Collaboration in protocol development
  • Systematic identification of suspected events
  • Access to an international group of clinical experts with experience in:
        • Clinical trials
        • Event review and adjudication
  • Expertise in event packet preparation and review<
  • Liaison with regulatory agencies
  • Peer-reviewed publications on CEC processes and results

Contact

    Kenneth W. Mahaffey, MD
    Director, CEC
    Associate Professor
    mahaf002@mc.duke.edu
    +1.919.668.8845

    Arvilla Johnson, RN, MA
    Associate Director, CEC
    arvilla.johnson@duke.edu
    +1.919.668.8248

    Amy Scarlett
    CEC Administrative Assistant
    amy.scarlett@duke.edu
    +1.919.668.4636
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