Canada's clinical trial regulatory landscape is uncompromisingly complex. Securing clinical trial authorization demands approval from Health Canada requirements, provincial health authorities, research ethics boards, and institutional review committees across 13 distinct jurisdictions. As a result, over 85% of multi-site Canadian trials face regulatory delays driven by inconsistent provincial interpretations of Good Clinical Practice (GCP) guidelines and ambiguous review processes that can delay project timelines by up 6 months.
This certified program is designed to deliver a comprehensive understanding of Canada's GCP framework and equip you to navigate its complexities with confidence. You will gain expertise in critical areas including Health Canada's GCP compliance requirements, the clinical trial authorization process, research ethics submissions, informed consent obligations, and investigator responsibilities. The program also covers pharmacovigilance regulations, adverse event reporting, and the data integrity standards required for clinical trials in Canada.
Beyond regulations, you will master practical strategies to embed GCP principles into trial design and execution, ensuring compliance at every stage. This includes navigating multi-site ethics approvals, implementing rigorous data and document management systems, conducting effective monitoring, and preparing decisively for Health Canada inspections. You will also gain insights into harmonizing Canadian GCP requirements with international standards when managing global or multi-jurisdictional trials. By the end of this program, you will be fully equipped to manage the operational, ethical, and legal challenges of Canada's GCP framework while strengthening participant safety and data reliability.
Upon completing the program and passing the Chartered exam, you will attain the Certified Canada Good Clinical Practice
Manager (CGCP™) designation. This globally recognized, industry-leading certification demonstrates your ability to interpret Canadian clinical trial regulations, implement robust GCP-compliant systems, and lead inspection-ready studies. With lifelong validity and global relevance, the credential will position you as a trusted authority in clinical research compliance and trial management excellence.
1 Chartered Institute of Professional Certifications' reviews and ratings are a comprehensive collection of participants feedback we have gathered over the last decade. To view authentic and personal testimonials that are handwritten by our participants, please download our participants' written reviews here.
This program will entitle you:
Pricing & Registration- Experience 3 days of instructor-led live training and gain a comprehensive, practice-oriented command of Canada's clinical trial regulatory framework—including ICH E6 Good Clinical Practice, Health Canada requirements, Clinical Trial Applications (CTA), and safety reporting obligations.
- Earn the industry-recognized Certified Canada Good Clinical Practice Manager (CGCP™) designation, demonstrating your authority to lead compliant, ethical, and audit-ready clinical trials in Canada.
- Develop practical expertise across critical clinical trial processes—including CTA preparation, informed consent, TMF governance, CAPA implementation, and pharmacovigilance—enabling you to ensure regulatory compliance, elevate data quality, and maintain consistent inspection readiness throughout the trial lifecycle.
- For inquiries, chat with our Program Advisers at [email protected] or call us at
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- Canada: +1 833 879 8820
- USA: +1 888 745 8875
Accreditations
This program is accredited by the Chartered Institute of Professional Certifications, which sets and maintains the governing standards for every professional who completes this program.
The content of this program has been fully certified and accredited by the CPD Certification Service as conforming to Continuing Professional Principles. CPD is the leading independent CPD accreditation institution operating across industry sectors, complementing the Continuing Professional Development policies of professional institutes and academic bodies. The CPD Certification Service provides support, advice, and recognized independent CPD accreditation aligned with global CPD principles.
What Can You Expect From This Live Program
Robust GCP compliance is non-negotiable in Canada, where over 900 clinical trials are authorized annually and inspection findings frequently cite documentation gaps and protocol deviations. Non-compliance can delay approvals, trigger costly remediation, or halt trials entirely. With global sponsors prioritizing high-quality, inspection-ready data, strong GCP capability is essential to protect participants, secure data integrity, and maintain Canada's standing as a trusted clinical research hub.
This certified program is built to equip you with a comprehensive and practical command of Canada's clinical trial regulatory framework and GCP requirements across the full study lifecycle. You will develop authoritative expertise in ICH E6 (R2) and emerging R3 expectations, Clinical Trial Applications (CTA), Research Ethics Board (REB) processes, informed consent, and participant protection—enabling you to navigate regulatory requirements with confidence and make informed, compliant decisions in real-world trial settings. By integrating Canadian-specific requirements—including Health Canada submissions, review processes, and ethical standards—the program ensures you can apply global GCP principles effectively within the local regulatory landscape.
The program also strengthens your ability to implement and lead compliant clinical trial operations. You will develop the practical skills required to design high-quality, inspection-ready protocols aligned with ICH E6 and E8, implement risk-based quality management (RBQM) to drive efficiency and oversight, and maintain robust Trial Master Files (TMFs) that support audit readiness. You will further enhance your capabilities in safety reporting, CAPA management, deviation handling, vendor oversight, and monitoring strategies—empowering you to proactively identify risks, secure data integrity, and ensure consistent regulatory compliance. By the program's end, you will be fully prepared to lead GCP-compliant trials with confidence, optimize operational performance, and command regulatory inspections and audits.
Upon completing the program and passing the Chartered exam, you will earn the Certified Canada Good Clinical Practice Manager (CGCP™) designation. This industry-recognized credential validates your expertise in ICH E6 Good Clinical Practice, Canadian clinical trial regulations, and GCP compliance systems—positioning you as a trusted professional ready to lead compliant clinical trials, strengthen regulatory oversight, and deliver inspection-ready, high-quality research operations.
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
Your Faculty Director
Dr. Yatika Kohli is a highly accomplished clinical research and regulatory leader with over 23 years of global experience across the biotechnology and pharmaceutical sectors. She is widely recognized for her authoritative expertise in Canada Good Clinical Practice (GCP) and has successfully led regulatory strategy, Clinical Trial Applications (CTA/IND/IMPD), and end-to-end clinical operations for more than 38 Phase I–IV trials across North America, Europe, and Asia-Pacific. Her extensive engagement with regulatory authorities, including Health Canada, the FDA, and the EMA, positions her as a trusted authority in GCP compliance, inspection readiness, and clinical governance.
Dr. Kohli has played a pivotal role in securing regulatory approvals for vaccines, biologics, and biosimilars—including several high-impact and commercially significant products. She has held senior leadership positions, where she has established and strengthened GxP-compliant quality systems, ensuring operational excellence and audit readiness across complex clinical programs. Renowned for her ability to translate dense regulatory requirements into practical, execution-focused strategies, she is also an experienced educator who delivers highly engaging, insight-driven training to clinical and regulatory professionals worldwide.
Certified Canada Good Clinical Practice Manager (CGCP™) Program Agenda
Chartered Exam
At the end of the program, there will be a Chartered exam comprised of 50 multiple choice questions. Upon passing, you will be accredited with the Certified Canada Good Clinical Practice Manager (CGCP™) designation.
- 98% of students who have taken this exam have passed successfully. Almost all professionals who complete our courses pass on their first attempt and earn their Certified Canada Good Clinical Practice Manager (CGCP™) designation.
- The exam comprises 50 multiple choice questions; you need to answer 25 out of 50 questions correctly to pass.
- You can re-take the exam online as many times as you want, with no additional charges for retakes.
- The program cost already includes the exam fees, so there are no additional charges for taking the exam.
If you encounter challenges passing the exam, you can secure dedicated assistance from our team and faculty leader to help you succeed.
Certified Canada Good Clinical Practice Manager (CGCP™) Designation
Upon successful completion of this program, you will be awarded the Certified Canada Good Clinical Practice Manager (CGCP™) designation, which can be added to your resume, CV, and professional credentials. This industry-recognized certification carries lifelong validity.
Globally recognized, this certification affirms your authority to lead ethically sound, regulatory-compliant clinical trials within the Canadian framework. It validates your ability to apply ICH GCP principles, navigate Health Canada requirements, oversee trial stakeholders, and ensure participant safety and data integrity across the clinical trial lifecycle. Developed by the Chartered Institute of Professional Certifications, this program is independently accredited by the CPD Certification Service, reflecting the highest standards of continuing professional development.
Pricing & Registration
Canada
Dates: 18 - 20 Nov 2026
Venue: Online Executive Program (via Zoom)
Time: 9:00am - 4:30pm Pacific Time (PT)
10:00am - 5:30pm Central Standard Time (CST)
11:00am - 6:30pm Eastern Standard Time (EST)
| Early Bird Packages | Regular Pricing | ||
|---|---|---|---|
| By 15 Sep 2026 | By 27 Oct 2026 | After 27 Oct 2026 | |
| Canada Delegates | CAD 2,395 | CAD 2,595 | CAD 2,695 |
Group Discount: 2nd participant get 10%, or register 3 participants and 4th participant get a complimentary seat (1 discount scheme applies)
Register NowDownload Brochure
Download our program brochure below. For any inquiries, please contact our Program Advisor at [email protected] or call us at:
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- Canada: +1 833 879 8820
- USA: +1 888 745 8875
On Demand Learning
If you are unable to make it to this program due to the dates, you can also enroll into our program through our on-demand learning. Click on the link below to go to our on demand learning to discover how you can enroll into the program and earn your Charter or certificate through our on demand learning platform.
Go to Our On Demand Learning Here
Convincing Your Boss To Attend This Program
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Certified Canada Good Clinical Practice Manager (CGCP™)
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