Data Safety & Monitoring Board (DSMB) Establishment
Course Description:
This course examines how Data Safety and Monitoring Boards (DSMBs) operate and make a significant difference in studies. It illustrates how independent, third-party assessments of study performances and patients not only ensure adequate protection of the patients participating in the study, but also guarantee regulatory bodies (notified bodies and competent authorities) that both safety and performance are sufficiently, continuously, and impartially assessed.
Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Comprehend, define, and apply the essential elements, responsibilities, and functions of DSMBs, including:
- Definition of DSMBs, their purpose, and how they function
- Overview of independence, ethics, and patient protection
- Standards and regulations
- Key operational steps
- Members and agreements
- Meetings
- Charters
- Protocol and continuation or discontinuation criteria
- Stopping rules
- Reporting
- DSMB statistics
- DSMB data management
Who Should Enroll:
Professionals or active members involved in establishing or managing DSMBs are welcome to enroll in this course.
Prerequisite Knowledge/Requirements:
There is no prerequisite knowledge required for this course; all areas of expertise are welcome.