Overview

This module provides a comprehensive framework for understanding drug safety requirements in human clinical trials. It covers key ethical and safety safeguards, including informed consent, Institutional Review Boards and Ethics Committees, and Data Safety Monitoring Boards. Learners will also explore individual case and aggregate reporting requirements, risk assessment, and the evaluation of safety data in pre-marketing applications, reinforced through a real-world case study.

The module takes an average of 3.75 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).

Featured topics

- Clinical Trial Subject and Data Oversight
- Individual Case Reporting
- Aggregate Reporting
- Risk Assessment
- Pre-Marketing Review of Safety Data in a Marketing Application
- Case Study

Who should attend?

This module is designed for professionals involved in:
- Clinical safety and pharmacovigilance
- Clinical research
- Quality assurance
- Compliance
- Medical affairs
- Marketing with a focused interest in pharmacovigilance

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

Have an account?

Register

Pre-Marketing Clinical Trial Safety

Overview

Featured topics

Who should attend?

Learning objectives

Be informed and stay engaged.