Clinical Events Classification

The DCRI Clinical Events Classification (CEC) group uses innovative strategies, including streamlined data workflows so that adjudicated endpoint data are available on time for the Independent Data Monitoring Committee (IDMC), database lock, and other important timelines throughout a trial.

CEC services are essential to secure FDA or EMA approval for drugs and devices in a wide range of therapeutic areas, including:

  • Cardiovascular
  • Gastroenterology
  • Infectious Diseases
  • Medical Devices
  • Nephrology
  • Neurology
  • Oncology
  • Pediatrics
  • Respiratory Medicine

CEC Solutions

CEC has experience in adjudication across numerous therapeutic areas, including cardiovascular studies, respiratory medicine, infectious diseases, gastrointestinal and liver disease, kidney disease, and pediatrics. Comprehensive services for the development of highly efficient events adjudication programs include:

  • A tailored approach to efficacy review and event validation that is adaptable to protocol requirements in both model and cost.
  • Clinical events adjudication processes, performed in 21 CFR part 11 compliant adjudication systems, that enable secure, global access for all physician reviewers.
  • Collaboration in protocol development.
  • Access to an international group of clinical experts with experience in clinical trials and event review/ adjudication in many therapeutic areas, including: Cardiology (Drugs and Device), Infectious Disease, Nephrology, Neurology, Oncology, Pediatrics and GI.
  • Systematic, comprehensive, unbiased, blinded and independent clinical event adjudication of suspected events.
  • Clinical preparation and review of event packets dossiers within a secure adjudication system.
  • Proven leadership in providing adjudication guidance aligned with regulatory agencies.
  • Leadership in peer-reviewed publications on clinical events adjudication processes and results.
Staff in a meeting

DCRI’s Arrhythmia Core Laboratory

In addition to these services, CEC offers high-quality evaluation, adjudication, and validation of electrocardiographic and electrogram review through DCRI’s Arrhythmia Core Laboratory. Our experienced adjudicators—comprised of HRS board-certified faculty of electrophysiologists—collaborate with other trial support units helping to further set us apart.

Clinical Events Classification info boxes

The Backbone of Our Work

EC’s work affects patient lives and is one of the most critical steps in the clinical research process to ensure accurate clinical outcomes. Each project is met with a commitment to:

• Rigor and discipline in every project
• Streamlining communications and
seamlessly managing the adjudication process
• Continuing the proven track record of meeting or exceeding milestones

• An obsession with quality
• The drive to get it done right the first time to avoid double work
• Extensive experience submitting data to the FDA and EMEA, and firsthand knowledge of the standards they expect

• Adaptable approaches to adjudication models, systems and workflows
• Implementation of complex trigger programming to support a robust and efficient event identification process
• Adjudication algorithms/auto adjudication processes to programmatically define adjudication values and event type details

Research Highlights


The EUCLID trial incorporated multiple aspects of clinical event surveillance and adjudication with over 11,000 triggers completed.


For a recent global, phase III, double-blind, placebo-controlled study, the CEC team was brought in to adjudicate eight events at study end. Only seven weeks passed between the contract signature and the end-of-study deliverable. The average CEC startup process takes three months.


Cardiovascular adverse events in the drug-development program of bupropion for smoking cessation: A systematic retrospective adjudication effort.

In the 1990s, CEC was a paper-driven process, with a focus on cardiovascular trials, and with medical records being translated into English on-site.

Today, adjudication is fully electronic, data security is at the forefront, and innovations are being made in response to new technology platforms and evolving definitions of outcomes. Consideration of how safety and efficacy outcomes are defined, reported, and monitored accurately in a given study has led to development of integrated systems, processes, and operations. Translation vendors are more predominant, responding to increasing numbers of global trials.

DCRI Safety Surveillance

DCRI Safety Surveillance

DCRI Safety Surveillance ensures on-time ascertainment and clinical evaluation of serious adverse events (SAEs), adverse device effects (ADEs), and other safety events through the development and skilled implementation of protocol-aligned safety management processes. Our team of Duke/DCRI faculty Safety Medical Monitors and expert safety associates with clinical nursing and pharmacy backgrounds have access to best-in-class medical, regulatory, and data/technical support, to ensure reliable, timely and accurate safety processes and systems, customized for every project.


  • Specifications and user testing for EDC forms relevant to safety event reporting, and for the secure, project-specific safety database.
  • Writing the protocol-aligned safety management plan, working instructions and site safety report training.
  • Reconciliation of safety event critical fields between clinical and safety databases.
  • Medical assessment of criteria for expedited event reporting and preparation of MedWatch/CIOMs reports for regulatory reporting, site/IRB notification.
  • Safety consulting and investigator training.

236+ completed trials ♦ 165K+ Events Processed ♦ 15+ Active Trials



Program Medical Director; Clinical Events Classification Director, CEC-SS; Professor of Medicine, Cardiology
Medical Director, Safety Surveillance; Associate Professor of Pediatrics, Division of Allergy, Immunology and Pulmonary Medicine
Assistant Director; Clinical Events Classification- Arrythmia Core Lab
Director of Operations, Clinical Events Classification-Safety Surveillance
Assistant Director, Safety Surveillance