Understanding and Managing the US Clinical Trial Process [4.0 RAC]

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.