Applicable Regulations & Laws in Clinical Research

Learn the regulatory and ethical frameworks that govern clinical research across jurisdictions. This course introduces ICH‑GCP, Health Canada’s Part C, Division 5 regulations, Good Documentation Practices (GDP), U.S. human subject protections (45 CFR 46), and the historical evolution of global clinical research guidance.

Course Benefits & Career Prospects

• Understand major international and Canadian regulatory requirements for clinical trials.
• Interpret ICH‑GCP principles and their application to compliant, ethical research conduct.
• Maintain data integrity through proper documentation and record management practices.
• Support regulatory submissions, audits, and inspection readiness in research settings.
• Job placement assistance: guidance toward roles in regulatory affairs, QA/Compliance, or site operations support.

Modules

• Historic Perspective & Evolution of Clinical Research Guidelines
• ICH‑GCP Guidelines
• Part C, Division 5 – Health Canada Food and Drug Regulations
• Data Integrity & Good Documentation Practices (GDP)
• 45 U.S. Code of Federal Regulations – Part 46 (Human Subjects Protection)