Pre-Marketing Clinical Trial Safety
The module takes an average of 4 hours to complete.
"Excellent module! Well organized and explained. I loved the interactive elements in the module to entertain and reinforce learning!"
- Informed Consent
- Institutional Review Boards and Ethics Committees
- Data and Safety Monitoring Boards
- Individual Case Reporting
- Aggregate Reporting
- Clinical Trial Safety Case Study Activity
- Risk Assessment
- Pre-marketing Review of Safety Data in a Marketing Application
Who should attend?
This module is designed for professionals involved in:
- Drug safety and pharmacovigilance
- Clinical research and development
- Quality assurance and compliance
- Regulatory affairs
- Medical affairs
Upon completion of this module, learners should be able to:
- Discuss the purpose of informed consent in clinical trials
- Define the roles of institutional review boards, ethics committees, and data and safety monitoring boards in clinical trials
- Explain pre-marketing individual case reporting, aggregate reporting requirements, and review of safety data in marketing application
- Describe risk assessment in clinical trials