Course Scope
This comprehensive training program provides clinical research professionals with the knowledge and practical skills required to conduct clinical trials in compliance with Health Canada Food and Drug Regulations (Part C, Division 5) and the International Council for Harmonisation (ICH) E6(R3) Good Clinical Practice (GCP) guideline.
The course emphasizes participant safety, ethical conduct, regulatory compliance, data integrity, quality management, and inspection readiness throughout the clinical trial lifecycle. The curriculum is aligned with Health Canada’s adoption of ICH E6(R3) effective April 1, 2026.
Included within scope:
- Health Canada regulatory requirements for clinical trials (Part C, Division 5)
- ICH E6(R3) Good Clinical Practice principles and Annex 1
- Sponsor, Qualified Investigator (QI), and Research Ethics Board (REB) responsibilities
- Clinical trial application (CTA) and amendment (CTA-A) processes
- Informed consent requirements and participant protection
- Safety reporting obligations (AEs, SAEs, SUSARs)
- Data governance and record keeping requirements
- Quality management and risk-based monitoring
- Investigational product management and GMP compliance
- Clinical trial inspections and enforcement
Excluded from scope:
- Medical device clinical trials (covered under separate regulations)
- Natural Health Product (NHP) trials
- Observational studies without drug intervention
- Veterinary clinical trials
Course Objectives
Upon successful completion of this training program, participants will be able to:
Regulatory Knowledge:
- Understand Health Canada’s regulatory authority for clinical trials
- Interpret and apply Part C, Division 5 of the Food and Drug Regulations
- Navigate the ICH E6(R3) Good Clinical Practice guideline
- Distinguish between sponsor, investigator, and REB responsibilities
Clinical Trial Conduct:
- Prepare and submit Clinical Trial Applications (CTAs) and Amendments (CTA-As)
- Implement risk-based and proportionate approaches to trial management
- Ensure participant protection through informed consent and safety monitoring
- Maintain essential documents and trial master files
- Conduct source documentation and data management in accordance with ALCOA+ principles
Quality and Compliance:
- Implement quality management systems and risk-based quality management
- Manage investigational product accountability and GMP compliance
- Detect, document, and report protocol deviations and violations
- Prepare for Health Canada GCP inspections
- Implement corrective and preventive actions (CAPA)
Ethical Conduct:
- Apply the ethical principles of the Declaration of Helsinki
- Protect the rights, safety, and well-being of trial participants
- Obtain and document informed consent appropriately
- Protect participant confidentiality and privacy
Safety Reporting:
- Identify and report adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs)
- Comply with Health Canada safety reporting timelines
- Conduct safety follow-up and annual safety reporting
Target Audience
This training is intended for all individuals and organizations involved in the conduct of clinical trials of drugs in human participants in Canada. The content is tailored to the specific responsibilities of each role.
Primary audiences include:
- Sponsors (commercial and non-commercial/academic)
- Qualified Investigators (QIs) and Principal Investigators
- Sub-Investigators and clinical research staff
- Research Ethics Board (REB) members and administrators
- Clinical Research Coordinators and study site personnel
- Contract Research Organizations (CROs) and Service Providers
- Data managers and biostatisticians
- Clinical monitors and auditors
- Pharmacists and investigational product handlers
- Regulatory affairs professionals
- Quality assurance professionals
- Pharmacovigilance professionals
- Research nurses
- Healthcare professionals involved in clinical research
Regulatory References
This training is built upon the following authoritative regulatory and guidance documents:
Canadian Regulations and Guidance
- Part C, Division 5 of the Food and Drug Regulations – Drugs for Clinical Trials Involving Human Subjects
- Food and Drugs Act – Legislative authority for clinical trial regulations
- ICH E6(R3) Guideline for Good Clinical Practice – Fully adopted by Health Canada effective April 1, 2026
- ICH E8(R1) General Considerations for Clinical Studies – Complements E6(R3) implementation
- Guidance Document: Part C, Division 5 (GUI-0100) – Health Canada’s interpretation guide
- Annex 13 to the GMP Guidelines: Drugs Used in Clinical Trials (GUI-0036)
- Guidance for Clinical Trial Sponsors: Clinical Trial Applications
- Guidelines for environmental control of drugs during storage and transportation (GUI-0069)
- Risk classification guide for observations related to inspections of clinical trials of human drugs (GUI-0043)
International Guidelines
- Declaration of Helsinki – Ethical principles for medical research
- Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2 2022)
- ICH E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
- ICH E3 Structure and Content of Clinical Study Reports
- ICH Q1A(R2) Stability Testing of New Substances and Products
Certification Details
Upon successful completion of this training program, participants will receive a certificate of completion documenting their understanding of Health Canada GCP requirements.
Certification Requirements:
- Complete all 17 training modules
- Achieve a passing score of 80% or higher on each module
- Complete all module knowledge checks (10 questions per module)
Training Records:
- Training records must be documented, monitored, and retained
- This program provides downloadable certificates and maintains records of completion for organizational audit and inspection purposes
