Clinical trials are critical in the development of new drugs, biologics, and medical devices. This course provides an introduction to the organization of clinical trials and the development of clinical monitoring plans. Students will gain an understanding of the essential components of clinical trials, the regulatory framework for clinical trials, and the principles of clinical monitoring plan development.
The course covers topics such as clinical trial design and protocol development, the regulatory framework for clinical trials, data collection and management in clinical trials, adverse event reporting and management, ethical considerations, regulatory compliance, and audits.
Upon completion of this course, students will be able to apply their knowledge to design and conduct clinical trials, understand the role of sponsor and investigator as well as steps involved in site training and site initiation. This course is ideal for individuals who are interested in pursuing a career in clinical research, regulatory affairs, or clinical trial management.
Learning Points:
