Explore the world of clinical research with our comprehensive course, designed to provide an in-depth understanding of the regulations, guidelines, and ethical principles fundamental to this field. This course delves into the history and development of Good Clinical Practices (GCP) and the regulatory landscape of clinical research, both in North America and globally.
Ethical Foundations: Learn about the pivotal historical events like the Nuremberg Trials and the Tuskegee Syphilis Study that shaped research ethics, focusing on principles such as respect for persons, beneficence, and justice. Understand the role of Ethics Committees in upholding these standards.
Regulatory Framework: The course covers crucial aspects of clinical trial design, conduct, monitoring, and reporting, including ICH E6 (GCP) guideline. Dive into the intricacies of study protocols, case report forms, and adverse event reporting.
Practical Applications: Through case studies and real-world scenarios, students will engage with the practicalities of clinical research regulations and GCP, enhancing critical thinking and problem-solving skills.
Interactive Learning: Group discussions and assignments are integrated to foster a deeper understanding and application of course materials.
Graduates of this course will emerge with a robust understanding of the global and Canadian regulatory frameworks governing clinical research. Equipped with this knowledge, students will be adept at designing and conducting clinical trials, ensuring compliance with regulatory requirements.
Key Learning Points:
Join us in this enlightening course to become proficient in the essentials of clinical research, positioning yourself as a knowledgeable and skilled professional in this dynamic field.