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Pre-Marketing Clinical Trial Safety
Overview
The module takes an average of 4 hours to complete.
This eLearning module can be purchased individually or as part of the Drug Safety eLearning Program (6 modules) or Drug Safety eLearning Bundle (7 modules).
"Excellent module! Well organized and explained. I loved the interactive elements in the module to entertain and reinforce learning!"
-Previous Participant
Featured topics
- 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
- Marketing
Learning objectives
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