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CR014 Good Clinical Practices (GCP), Research Ethics and Clinical Research Regulations

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.

Course Insights:

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.

Upon Completion:

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:

  • Navigating Clinical Regulations and ICH Guidelines
  • Mastery of the GxP Environment and Good Practice Guidelines
  • Comparison of Canadian vs. US Regulatory Framework (CTA, IND)
  • Deep Dive into the Principles of GCP
  • Roles and Responsibilities of Ethics Committees (IRB/REB)
  • Understanding Investigator and Sponsor Responsibilities
  • Protocols, Amendments, and Informed Consent Procedures
  • Insight into Investigator’s Brochure and Essential Documents

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.

  • + In Class Registration CAD$995 +HST
  • In-Class

Online Education Registration CAD$875 +HST

CR014 Good Clinical Practices (GCP), Research Ethics and Clinical Research Regulations