Practical Aspects of Clinical Trial Design/Conduct
Overall, I feel that this course offered a holistic view of the clinical environment by addressing the functional roles involved, the drug approval process and ethical considerations.
Due to the increasing complexity of clinical trials and new and evolving regulations, the pharmaceutical industry requires trained professionals in areas that design and implement clinical research trials.
This curriculum is designed to provide students with a basic understanding of good clinical practice and includes practical, hands-on experience in the multi-faceted area of clinical research. Topics of focus include including protocol development, protection of human subjects and informed consent regulations, data management and the use of electronic systems and tools, drug supply management, study monitoring activities and study reporting and labeling.
Upon completion of this course, students should have a basic understanding of the design, implementation of clinical trials and the reporting of clinical trial results.
This course is intended for students in the Master of Business and Science Program as well as MS, PharmD and PhD-level graduate students in the Life Sciences Graduate Programs, the School of Pharmacy, School of Biomedical Engineering and employees of Pharmaceutical and Biotechnology Industries.
Topics that will be covered in this course include the following:
· Introduction to clinical research, key players and FDA regulations/Good Clinical Practice (GCP)
· FDA IRB regulations and protection of human subjects
· Study designs and protocol development
· Safety monitoring
· Drug supply labeling, packaging and distribution
· Data management and data privacy
· Study management and site monitoring
· FDA Inspections
· Clinical study report and labeling