Description
Overview:
Stay Compliant with Canada’s Clinical Trial Regulations
The Health Canada Division 5 Training Course is designed to help clinical research professionals, sponsors, and investigators gain a comprehensive understanding of the regulatory requirements for conducting clinical trials in Canada. This course covers all key aspects of Division 5 of the Food and Drug Regulations, ensuring that participants are equipped to conduct trials in compliance with Health Canada’s standards.
This training is essential for those involved in the oversight, conduct, or management of clinical trials, providing detailed insights into trial design, safety reporting, record-keeping, and regulatory requirements.
Who Should Take This Course?
- Clinical Research Coordinators
- Clinical Research Associates
- Investigators
- Sponsors
- Regulatory Affairs Specialists
- Quality Assurance Professionals
Learning Objectives:
By the end of this course, participants will be able to:
- Understand the regulatory framework and scope of Health Canada’s Division 5.
- Identify the roles and responsibilities of sponsors, investigators, and ethics boards in clinical trials.
- Follow the proper procedures for Clinical Trial Application (CTA) submission.
- Ensure compliance with drug accountability, record-keeping, and safety reporting requirements.
- Navigate protocol amendments, trial discontinuance, and suspension or cancellation processes.
- Safeguard participant rights and ensure ethical conduct throughout the trial.
Course Content:
- Introduction to Health Canada Division 5
Overview of the regulatory framework governing clinical trials in Canada. - Sponsor and Investigator Responsibilities
Detailed explanation of the roles and obligations of sponsors and investigators, including trial design, safety monitoring, and record-keeping. - Clinical Trial Application (CTA) Process
Step-by-step guidance on preparing and submitting a CTA to Health Canada. - Safety Reporting and Adverse Events
Learn how to handle safety reporting, including adverse event (AE) and serious adverse event (SAE) management. - Record-Keeping and Compliance
Explore the requirements for essential records, drug accountability, and retention periods to ensure compliance with Health Canada’s regulations. - Discontinuance, Suspension, and Cancellation
Understand the processes involved in discontinuing a trial or having a trial suspended or canceled by Health Canada.
Why Take This Course?
Stay up-to-date with Canada’s Regulatory Requirements:
Clinical trials in Canada are subject to strict regulations under Division 5. This course ensures that you understand the legal obligations for conducting ethical and compliant trials.
Enhance Your Professional Skills:
Whether you are a clinical research coordinator, investigator, or sponsor, this course will enhance your knowledge of the regulatory landscape and help you manage trials more effectively.
Earn a Certificate of Completion:
Participants will receive a certificate upon successfully completing the course, demonstrating their commitment to maintaining high standards in clinical trial management.
How It Works:
- 100% Online
This course is delivered through our easy-to-use online learning platform, allowing you to study at your own pace. - Flexible Learning
Access the course materials anytime, anywhere, and complete the training on your schedule.
Enroll Today
Ensure your clinical trial practices align with Health Canada’s regulations by enrolling in the Health Canada Division 5 Training Program. Gain the confidence and knowledge needed to navigate the regulatory landscape with ease and keep your trials compliant.
