This module provides a framework and details around drug safety requirements for clinical trials for drugs in humans. It includes information about safety and ethical safeguards to protect human subjects in clinical trials including informed consent, institutional review boards and independent ethics committees, and data safety monitoring boards. Individual case reporting and aggregate reporting requirements are examined in detail. A case study with exercise questions provides real-world context and enables the learner to see how the concepts presented in the module apply in real life. Finally, the module will discuss risk assessment and the premarketing review of safety data in a marketing application.

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.

Learn more - https://www.diaglobal.org/en/course-listing/elearning/2017/04/premarketing-clinical-trial-safety