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:
- Identify the purpose and elements of informed consent in clinical trials
- Determine the roles of institutional review boards, ethics committees, and data and safety monitoring boards in clinical trials
- Recognize pre-marketing individual case reporting, aggregate reporting requirements, and review of safety data in marketing application
- Define risk assessment in clinical trials