Clinical Events Committee (CEC) Establishment
Course Description:
This course provides detailed information on Clinical Events Committees (CECs), which provide non-bias medical reviews and adjudications of clinical endpoint events. This course explores what CECs do, how they function, and what their roles and responsibilities are. It also reviews CEC database management and the standards and regulations by which clinical trials are conducted.
Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Comprehend, define, and apply the essential elements and duties that constitute a CEC, including:
- CEC member reports
- Adjudication forms, cases, and entries
- Adjudication minutes
- Requests for further information
Who Should Enroll:
Clinical project managers and directors, regulatory managers and directors, safety officers, complaint managers, professionals involved in establishing or managing CECs, and active CEC members are all encouraged to participate in this course.
Prerequisite Knowledge/Requirements:
The following course is required:
- Adverse Event Processes (ID 59)