This course is designed to provide students with a comprehensive understanding of the regulations and guidelines that govern clinical research and the principles of good clinical practices (GCP). The course will cover the history and development of GCP and the regulations governing clinical research in North America and globally.
Students will learn about the ethical considerations and informed consent process for clinical research, including the protection of human subjects and the role of Institutional Review Boards (IRBs) and Ethics Committees. The course will also cover the regulatory requirements including ICH for clinical trial design, conduct, monitoring, and reporting, including the development of study protocols, case report forms, and adverse event reporting. The principles of data management and the importance of maintaining accurate and complete study documentation will also be discussed.
Throughout the course, students will have the opportunity to analyze case studies and real-world scenarios related to clinical research regulations and GCP. Students will also develop critical thinking and problem-solving skills through group discussions and assignments.
Upon completion of the course, students will have a thorough understanding of the regulations and guidelines governing clinical research and the principles of GCP. Students will also be prepared to apply this knowledge to the design and conduct of clinical trials and to ensure compliance with regulatory requirements.