Clinical trials are essential to the evaluation of safety and efficacy for new drugs, biologics and medical devices. In addition, they are the critical, final milestone in product development when obtaining regulatory approval. As a regulatory professional, you have a significant role in clinical trial management, and 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 will provide an overview of the foundation for clinical trials in the US, including their historical evolution, ethical conduct and regulation. It will also address 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, will be reviewed from a regulatory perspective.
Learning Objectives
Upon completion of this course, students should be able to:
- Discuss the history and evolution of clinical trials
- Identify the importance of informed consent to the clinical research process
- Describe the major requirements in each applicable Code of Federal Regulations (CFR) 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 the conduct of clinical trials
- Describe the regulatory issues related to data management during a clinical trial
Target Audience
New personnel in regulatory, quality assurance, compliance, clinical operations and other related departments will benefit from this course.