Good Clinical Practice (GCP) excellence is fundamental to clinical research integrity, participant safety and data reliability. Organizations with robust GCP systems experience 40% fewer protocol deviations, complete studies 35% faster, and reduce audit findings by 70% compared to those with inadequate GCP implementations. GCP not only safeguards the rights and well-being of participants but also enhances operational excellence and strengthens the credibility of clinical research outcomes.
This certified program is designed to provide clinical trial leaders with comprehensive knowledge and critical skills necessary for the effective management of Good Clinical Practice compliance. Throughout the program, you will explore a broad range of core GCP management topics such as regulatory requirements across international jurisdictions, investigator site management, informed consent processes, protocol adherence, and quality assurance auditing. This program ensures that you will not only gain theoretical understanding but also develop practical competencies in leading GCP-compliant trials, implementing corrective and preventive action (CAPA) plans, and conducting rigorous site monitoring activities. You will emerge with the ability to build strong GCP frameworks, identify and mitigate compliance risks proactively, and drive operational excellence within clinical research settings.
Additionally, the program delves into specialized areas of GCP management including handling deviations and non-compliance incidents, navigating ethical review board requirements, and overseeing sponsor-investigator obligations. You will further strengthen your capabilities in documentation management, regulatory inspections readiness, and real-world application of risk-based monitoring techniques. Ethical leadership and participant-centered trial management are pivotal pillars of this program, preparing you to uphold the highest standards of ethical conduct while delivering trial results with scientific precision and regulatory excellence. By the end of the program, you will be fully prepared to lead GCP initiatives confidently, ensuring trials meet regulatory expectations and advance clinical innovations responsibly.
Upon completing the program and passing the exam, you will attain the Certified Good Clinical 
Practice Manager (CGCP™) designation. This prestigious credential will demonstrate your ability to lead high-quality, ethically sound, and regulation-compliant clinical trials internationally. Not only will this CGCP™ designation distinguish you as an expert well-versed in guiding your research organization on robust clinical trial strategy, but it may also open up new career advancement opportunities and enhance your overall credibility and reputation within the pharmaceutical and clinical research industries.
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This program will entitle you:
Download Brochure Pricing & Registration- Experience a 3-day instructor-led live program and gain in-depth knowledge of GCP principles, regulatory frameworks, and compliance protocols.
- Learn to build comprehensive quality management frameworks that ensure GCP compliance throughout clinical research and trials.
- Attain the industry-recognized Certified Good Clinical Practice Manager (CGCP™) designation, demonstrating your expertise in leading ethical, high-quality, and inspection-ready clinical trials.
- Master hands-on expertise in site oversight, informed consent, and risk-based monitoring while excelling in ethics submissions, pharmacovigilance, CAPA planning, and safeguarding data integrity in full compliance with ALCOA+ principles
- For inquiries, chat with our Program Advisors at advisor@charteredcertifications.com 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
- USA: +1 888 745 8875
Accreditations
This Certified Good Clinical Practice Manager (CGCP™) is a mark of excellence and distinction that signifies a fully qualified professional with advanced expertise in managing ethical, high-quality, and inspection-ready clinical trials. It is accredited by the Chartered Institute of Professional Certifications, which maintains the governing standards for all members. The CGCP™ charter is a trademarked charter available only to professionals who have completed and passed this program. The certification is governed and maintained by Chartered Institute of Professional Certifications with over 90,000 members around the world. It is also endorsed by prominent associations and organizations worldwide.
The content of this program has been fully certified and accredited by CPD as adhering to Continuing Professional Principles.
What Can You Expect From This Live Program
According to a recent study by the FDA, approximately 34% of clinical investigator inspection findings between 2020 - 2024 involved GCP violations such as inadequate record keeping, protocol deviations, or informed consent issues. These violations not only compromise data integrity but also pose significant risks to participant safety and regulatory approval. Strengthening GCP compliance frameworks is therefore essential to ensure ethical conduct, reliable outcomes, and successful trial execution.
This certified program is designed to equip clinical research professionals with the knowledge, tools, and strategies needed to proactively identify and address compliance risks, implement robust quality systems, and uphold the highest standards of ethical and regulatory conduct across all phases of clinical trials. Throughout the program, you will explore a broad range of core clinical research management topics such as strategic quality planning, advanced risk-based monitoring approaches, and rigorous inspection readiness preparation. This program will help you effectively oversee and optimize GCP compliance across any clinical research organization. You will emerge with the ability to develop comprehensive quality management systems, anticipate regulatory challenges, and influence trial strategy directly.
Additionally, the program will show you specialized GCP management techniques such as optimizing essential document systems with validated electronic solutions, managing cross-border regulatory variations, and understanding the intricacies of site oversight and clinical monitoring. You will also gain skills in protocol deviation management and investigational product accountability, alongside learning how to navigate inspection processes and regulatory interactions effectively. Ethical considerations and subject protection are also pivotal components of this program, preparing you to implement and evaluate clinical trial strategies that align with both scientific objectives and international ethical standards. By the end of the program, you will be equipped to assume high-level clinical research responsibilities, driving compliance strategy and fostering organizational excellence with confidence and precision.
Upon completing the program and passing the Chartered exam, you will attain the Certified Good Clinical Practice Manager (CGCP™) designation that will demonstrate your expertise in overseeing ethical, high-quality, and inspection-ready clinical trials. This CGCP™ credential will distinguish you as a trusted leader in driving compliant and high-performing clinical research internationally.
Key Skills You Will Gain
- GCP Regulatory Interpretation
- Research Governance Compliance
- Ethics vs Governance Differentiation
- Site Approval Optimization
- ICH GCP Guidelines
- Investigator Oversight
- Delegation Management
- Audit Readiness Planning
- Sponsor Role Clarification
- Therapeutic Goods Compliance
- Investigational Product (IP) Management
- Home-Use IP Protocols
- Clinical Trial Budgeting
- Conflict of Interest Management
- Statistical Trial Design
- Randomisation Implementation
- Unblinding Procedures
- Data Governance Strategies
- Essential Document Control
- Clinical Trial Reporting
- Participant Safety Monitoring
- Adverse Event Reporting
- DSMB Coordination
- Regulator Communication
- Risk Assessment and Evaluation
- Quality Assurance Integration
- Quality Control Implementation
- Post-Trial Reporting
- Early Trial Termination Handling
- Trial Design Selection
Your Faculty Director
Prof. Nikolajs Zeps is a distinguished leader in clinical research and Good Clinical Practice (GCP) compliance, recognized nationally for his exceptional contributions to advancing clinical and translational research. He currently serves as Director of Operations for the Cancer Research Program and Professor of Practice in the Department of Chronic Disease and Ageing at Monash University’s School of Public Health and Preventive Medicine. With an extensive executive background, Prof. Zeps previously held the position of Director of Research at Northern Health and has served in senior roles at St John of God HealthCare and Epworth HealthCare. He is also the Clinical Research Lead for Monash Partners and an Adjunct Professor at the Eastern Health Clinical School, Monash University.
Prof. Zeps has been instrumental in advancing clinical research capacity and Good Clinical Practice (GCP) compliance internationally. As a founding Director and Board Member of the Australian Clinical Trials Alliance (ACTA), he has led national initiatives such as rapid trial start-up and teletrials programs. He co-authored the Australian Clinical Trials Handbook for the TGA and received the NHMRC Ethics Prize for his outstanding contributions to human research ethics. Prof. Zeps chairs the PC4 Advisory Committee and drives national efforts to improve clinical trial accessibility and engagement through the VCCC Alliance’s clinical trial participation workstream.
Certified Good Clinical Practice Manager (CGCP™) Program Agenda
Chartered Exam
At the end of the program, there will be a Chartered exam comprising 50 multiple choice questions. Upon passing the exam, you will be accredited with Certified Good Clinical Practice Manager (CGCP™) designation.
- 98% of students who have taken this exam have passed the exam successfully. Almost all professionals who have taken our courses have passed this test and attain their Certified Good Clinical Practice Manager (CGCP™) designation.
- The exam has 50 multiple choice questions and you need to answer 25 out of 50 questions correctly to pass the exam.
- You can re-take the exam online as many times as you want, with no additional charges for retaking the exams.
- The program cost already includes the exam fees, so there are no additional charges for taking the exam.
If you have challenges passing the exam, you can secure assistance from our team and faculty leader to help you pass the exam.
Certified Good Clinical Practice Manager (CGCP™) Designation
Upon successfully attending this program, you will be awarded with the Certified Good Clinical Practice Manager (CGCP™) designation. that can be used in your resume, CV and other professional credentials. This certification is industry-recognized with lifelong validity.
Globally recognized, this certification affirms your expertise in leading ethically sound, regulatory-compliant clinical trials in Australia and across the APAC region. It demonstrates your ability to apply GCP principles within complex governance frameworks, oversee stakeholder responsibilities, and ensure participant safety and data integrity across diverse trial settings. Developed by Chartered Institute of Professional Certifications, the content of this program has been independently accredited by CPD Certification Service as adhering to the highest standards of continuing professional principles.
Pricing & Registration
Australia, APAC and China
Dates: 12 - 14 Jan 2026
Venue: Online Executive Program (via Zoom)
Time: 11:00am - 6:30pm Australian Eastern Daylight Time (AEDT)
8:00am - 3:30pm Singapore Time (SGT)
8:00am - 3:30pm China Standard Time (CST)
| Early Bird Packages | Regular Pricing | ||
|---|---|---|---|
| By 20 Oct 2025 | By 01 Dec 2025 | After 01 Dec 2025 | |
| Australia Delegates | AUD 2,595 | AUD 2,795 | AUD 2,895 |
| Singapore and Other Countries Delegates | SGD 2,595 | SGD 2,795 | SGD 2,895 |
| China Delegates | CNY 13,995 | CNY 14,995 | CNY 15,995 |
Group Discount: 2nd participant get 10%, or register 3 participants and 4th participant get a complimentary seat (1 discount scheme applies). Note: GST is applicable to participants from Singapore registered companies.
Register NowDownload Brochure
You can download our program brochure below. If you have any inquiries on this program, please contact our Program Advisor at advisor@charteredcertifications.com 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
- USA: +1 888 745 8875
Convincing Your Boss To Attend This Program
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Certified Good Clinical Practice Manager (CGCP™)
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