Clinical event committee or event adjudication committee (CEC)

Clinical event committee or event adjudication committee (CEC) File:Clinical Trial-6--.pdf

Overview

Clinical Events Committee (CEC) provides comprehensive clinical endpoints services for clinical trials and registries. The CEC services includes data management, document collection, document hosting, medical review and adjudication services. Current trials employ a paperless electronic clinical events adjudication system that allows for rapid communication, adjudication and archiving of events. Physician specialties include interventional and general Cardiology, Hematology, Neurology, Oncology, Endocrinology, and Hepatology to provide broad expertise across safety and efficacy events encountered in clinical trials.

Purposes

• The purpose of the CEC is to adjudicate and classify all events identified as potential organ system injury events based on investigator reported terms and identified Preferred Terms (PTs).

Roles

• The role of the CEC is to assist in identification of, and adjudicate the defined clinical events, in a blinded (treatment assignment, lipid results, and other core lab values that could unblind an adjudicator), consistent, and unbiased manner throughout the course of the study.
• The importance of the CEC is to ensure that defined events that have been reported are judged uniformly using the same definition by experts who are blinded to the treatment status.
• The aim of the CEC is to eliminate inherent variation by using standard criteria and definitions to adjudicate potential adverse events.

Responsibilities

• CEC responsibilities include making recommendations for site and adjudication CRF design, participating in testing of the adjudication system, assisting in event identification including review and approval of the Medical Dictionary for Regulatory Activity (MedDRA) trigger terms, determining required source documents for adjudication, assisting in site/CRA training, training of adjudicators and CEC support staff, event adjudication, and providing adjudication results to sponsor/Contract Research Organization within the agreed upon timelines as defined in the charter.

CEC Membership

• A CEC Chairperson oversees the CEC operations and has ultimate responsibility for the adjudication of all events.
• A CEC Project Manager coordinates all aspects of the clinical event adjudication process.
• The CEC Manager is responsible for the oversight of the organization and execution of the CEC process with the proper allocation of resources and adherence to the research protocol and CEC charter requirements. A complete list of the adjudicators for the trial is maintained on a separate signature and delegation log

Qualification and Selection of CEC Members

Individuals who will serve as CEC members are identified based on the following criteria:

(a) Credentials

The physicians participating in the adjudication process will meet the following requirements:

• Chairperson: Board-certified (or equivalent) cardiologist, with previous research experience as evidenced by publications and/or participation in clinical trials as a Principal Investigator or Co-Investigator. CEC Chairperson is responsible for oversight of the adjudication process and training of the adjudication team. He/She will also serve as the tie breaker for CV events when the initial adjudicators are not in agreement. He/She may act as a resource to the hepatic and neurologic adjudicators as needed.
• Potential Hepatic Injury Adjudicators: Phase I adjudication for potential hepatic injury events are performed by two specialists with advanced training in hepatology (liver disease), with previous research experience as evidenced by publications and/or participation in clinical trials and trained in the adjudication process. Phase II adjudication of potential hepatic injury events is performed by the same two individuals via teleconference.
• CV and Death Physician Adjudicators: Phase I Adjudication for death and cardiovascular events is performed by two cardiology fellows who are also board certified (or equivalent) in Internal Medicine, and have completed at least the first year of their cardiology fellowship and are trained in the adjudication process. Phase II adjudication will be performed by a board-certified or equivalent cardiologist or the CEC Chairperson also trained in the adjudication process.
• Neurology Adjudicator: Phase I Adjudication for neurologic events are performed by two board certified neurologists (or equivalent).
• Manager: A Research Program Manager, who is responsible for the operational oversight of the CEC
• Project Managers: Personnel with both clinical and research experience that are knowledgeable about the coordination, implementation, and the conduct of the CEC process. This person is the liaison between CEC and the sponsor.

(b) Affiliation

• Issues surrounding affiliations are resolved in accordance with the terms and conditions of the agreement.

(c) Previous research experience

• The adjudicators selected will have previous research experience as evidenced by publications and/or participation in clinical studies.

(e) Trial association

• The CEC Physician Adjudicators should not adjudicate for studies in which they are the Principal Investigator, a Co-Investigator, or in which they have any other direct or indirect involvement (e.g., Steering Committee Member, IDMC Member, Consultant, etc.).

Training

Training documents are maintained in the electronic trial master file (eTMF). Training may include the following:

(i) Overview presentation of the protocol.

(ii) Clinical events to adjudicate and their definitions.

(iii) Explanation of the clinical event package contents.

(iv) Utilization of the IBM Clinical Development Endpoint Adjudication System (EAS).

(v) Familiarization with adjudication conventions (e.g., electronic adjudication forms completion, generating queries, password reset, etc.).

(vi) Discussion of adjudication commitment, timelines and workload.

(vii) Demonstration of adequate performance on adjudicating test cases.