Certified Canada Good Clinical Practice Manager (CGCP™)
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78 Modules
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Live Executive Programs
Professional Designation Earned:
Certified Canada Good Clinical Practice Manager (CGCP™)
Lead compliant clinical trials in Canada—master GCP, regulatory frameworks, lifecycle management, and emerging practices to deliver inspection-ready, high-quality outcomes.
Key skills you will gain:
- Canada GCP Compliance
- ICH E6 (R2/R3) Implementation
- Health Canada Division 5 Compliance
- Clinical Trial Applications (CTA) Preparation
- No Objection Letter (NOL) Process
- Ethical Clinical Research Conduct
- Research Ethics Board (REB) Coordination
- CRO and Vendor Oversight
- Qualified Investigator (QI) Compliance
- Protocol Development and Design
- Risk-Based Quality Management (RBQM)
- Quality Management Systems (QMS)
- Trial Master File (TMF) Governance
- Essential Documents Management
- Data Integrity (ALCOA+)
- Electronic Data Systems (EDC/eCOA/eSource)
- Pharmacovigilance and Safety Reporting
- Adverse Event (AE/SAE/SUSAR) Management
- Monitoring Strategies (RBM/Hybrid Monitoring)
- Audit and Inspection Readiness
- Health Canada Inspection Management
- Corrective and Preventive Action (CAPA) Implementation
- Protocol Deviations and Compliance Management
- Clinical Data Management and Database Lock
- Statistical Analysis and Reporting Alignment
- Clinical Study Report (CSR) Preparation
- Trial Close-Out and Archiving Management