Understanding and Managing the US Clinical Trial Process

This course provides an overview of the foundation for clinical trials in the US including their historical evolution, ethical conduct and regulations and the responsibilities of parties involved in clinical research

Clinical trials are an essential part of the evaluation of safety and efficacy for new drugs, biologics and medical devices, and are critical to obtaining regulatory approval as the final milestone in product development. As a regulatory professional, you have a significant role in clinical trial management, so it is imperative that you understand the clinical research process and basic issues associated with the infrastructure elements required for the successful management of clinical trials.

This course provides an overview of the foundation for clinical trials in the US, including their historical evolution, ethical conduct and regulations and the responsibilities of parties involved in clinical research. The types and phases of clinical trials and protocol development, as well as key issues related to clinical trial management and monitoring, are reviewed from a regulatory perspective.

At a Glance

Target Audience: This course is designed for new personnel in regulatory, quality assurance, compliance, clinical operations and other related departments.

Learning Level: Basic

Total Length of Course: 4 Hours

RAC Points: 4

Pharmaceutical Certificate Elective

Enrollment Period: 12 months

Learning Objectives

Discuss the history and evolution of clinical trials

dentify the importance of informed consent to the clinical research process

Describe the major requirements in each applicable Code of Federal Regulations (CFR) section related to clinical research

Outline the steps of clinical trial development and execution

Distinguish between different types and phases of clinical trials

Outline the roles and responsibilities for conducting clinical trials