The European Union’s Good Clinical Practice (GCP) framework has become increasingly complex. The number of compliance checkpoints has doubled in the past five years and clinical trial sponsors now face a 50% rise in documentation requirements since 2020. Additionally, the introduction of the Clinical Trials Information System (CTIS) has added new layers of reporting obligations, while the ICH E6(R3) revisions have expanded sponsor and investigator accountability, making GCP compliance a multifaceted challenge across 27 member states.
This certified program is designed to provide you with a comprehensive understanding of the EU GCP landscape, equipping you with the knowledge and tools to manage every stage of the clinical trial lifecycle - from protocol development and ethics submissions to data integrity and post-trial reporting. You will explore key areas such as investigator and sponsor responsibilities, ethics committee oversight, informed consent under GDPR, risk-based quality management (RBQM), data integrity (ALCOA+), and pharmacovigilance reporting. Through practical case studies and regulatory insights, you will develop the competence to lead compliant trials, manage Corrective and Preventive Actions (CAPA), and ensure continuous quality improvement.
Additionally, this program will cover emerging trends transforming EU clinical research, including decentralized and hybrid trials (DCTs), AI-driven data analysis, and real-world evidence (RWE) integration. Ethical leadership and participant-centered management are embedded throughout, ensuring you can confidently uphold patient rights while driving operational 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 internationally recognized credential validates your ability to lead high-quality, ethical, and regulation-compliant clinical trials across Europe and beyond.
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This program will entitle you:
Download Brochure Pricing & Registration- Experience a 3-day instructor-led program covering EU GCP principles, ICH E6(R3) updates, and compliance with EU Clinical Trials Regulation (CTR 536/2014) and GDPR requirements.
- Develop robust quality management systems (RBQM), oversee CROs and sponsors effectively, and ensure compliance through rigorous documentation and monitoring practices.
- Attain the industry-recognized Certified Good Clinical Practice Manager (CGCP™) designation, demonstrating your expertise in leading ethical, high-quality, and inspection-ready clinical trials.
- Gain hands-on expertise in CTIS operations, ethics committee coordination, informed consent, CAPA implementation, pharmacovigilance, and data integrity aligned with ALCOA+ and EMA guidelines.
- 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
- Canada: +1 833 879 8820
- 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 in EU. 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 recent data, approximately 36% of inspected clinical trials in the EU between 2020 and 2024 exhibited GCP violations, primarily related to inadequate documentation, protocol deviations, and failures in informed consent processes. These breaches led to study suspensions and increased regulatory scrutiny, jeopardizing data accuracy as well as participant welfare. Robust GCP compliance measures are therefore indispensable for upholding ethical standards, safeguarding patient safety, and securing the regulatory success of clinical research.
This certified program is designed to equip clinical research professionals, sponsors, and investigators with the knowledge, tools, and strategies required to manage Good Clinical Practice (GCP) compliance effectively under the EU Clinical Trials Regulation (CTR 536/2014) and ICH E6(R3). You will gain the expertise to identify and address compliance risks proactively, implement robust quality systems, and uphold the highest standards of ethical and regulatory conduct across all phases of clinical research. Throughout the program, you will explore the full spectrum of GCP management, including strategic quality planning, risk-based monitoring (RBQM), trial master file (TMF) management, CRO oversight, and inspection readiness to ensure full alignment with EU and EMA expectations.
Additionally, this program will guide you through specialized GCP management techniques such as ethical foundations of GCP, clinical research principles, and the integration of quality management into trial design. You will gain an in-depth understanding of ethics committee roles, informed consent under GDPR, and the protection of vulnerable populations through sound risk–benefit assessments. You will explore investigator and sponsor responsibilities, including site management, vendor qualification, staff training, and effective sponsor communication. You will focus on protocol development, emphasizing quality-by-design principles. You will learn to manage Investigational Medicinal Products (IMPs) in compliance with GMP, and maintain data integrity following ALCOA+ standards. Key sessions on pharmacovigilance provide insight into AE, SAE, and SUSAR reporting, guiding you on post-trial obligations, transparency requirements in CTIS, and long-term data archiving.
By the end of the program, you will be fully prepared to lead ethically robust, inspection-ready, and regulation-compliant clinical trials that meet the highest standards.
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 in the EU.
Key Skills You Will Gain
- GCP Compliance
- ICH E6(R3) Implementation
- EU CTR 536/2014 Compliance
- Ethical Clinical Research Conduct
- Risk–Benefit Assessment
- GDPR & Participant Privacy
- Ethics Committee Oversight
- Investigator Site Management
- Sponsor Oversight
- CRO Management
- Trial Master File (TMF) Administration
- Risk-Based Quality Management (RBQM)
- Quality-by-Design (QbD) in Clinical Trials
- Protocol Development & Review
- Statistical Analysis Planning
- Data Integrity (ALCOA+)
- Electronic Data Capture (EDC/eCRF)
- Investigational Medicinal Product (IMP) Management
- Good Manufacturing Practice (GMP) Compliance
- Pharmacovigilance Reporting
- Adverse Event (AE/SAE/SUSAR) Management
- Audit & Inspection Readiness
- Corrective & Preventive Action (CAPA)
- Continuous Quality Improvement
- CTIS Submission & Transparency
- Clinical Study Report (CSR) Preparation
- Post-Trial Obligations Management
- Decentralized & Hybrid Trials (DCTs)
- Real-World Data (RWD) & Evidence (RWE) Integration
- Ethical Leadership in Clinical Research
Your Faculty Director
Dr. Agnieszka Sokol is a distinguished expert in Good Clinical Practice (GCP) compliance, clinical quality management, and regulatory training, with over 18 years of experience in the pharmaceutical and biotechnology industries. She has held senior roles at argenx, Samsung Bioepis, Covance (for MSD), and Roche Poland, where she led global initiatives in audit and inspection readiness, quality system development, and risk-based trial oversight.
As an independent consultant, Dr. Sokol advises pharmaceutical companies, biotech firms, and CROs on GCP auditing, inspection facilitation, and continuous quality improvement. A passionate educator, she collaborates with Jan Kochanowski University, Collegium Medicum, AIDIFY, and the Polish Association for Good Clinical Practice (GCPpl), delivering specialized training on GCP, audit preparation, and quality systems.
Dr. Sokol holds a PhD and MSc in Biology from the University of Warsaw, and a Postgraduate Diploma in Bioethics and Medical Law from Cardinal Stefan Wyszyński University. A certified coach (SET Academy, Warsaw) and active member of GCPpl, she is dedicated to advancing ethical, compliant, and high-quality clinical research globally.
Certified EU 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 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 of 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 the EU 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
EU
Dates: 24 - 26 Jun 2026
Venue: Online Executive Program (via Zoom)
Time: 9:00am - 4:30pm British Summer Time (BST)
10:00am - 5:30pm Central European Summer Time (CEST)
| Early Bird Packages | Regular Pricing | ||
|---|---|---|---|
| By 20 Apr 2026 | By 01 Jun 2026 | After 01 Jun 2026 | |
| EU Delegates | EUR 1,695 | EUR 1,895 | EUR 1,995 |
| Switzerland Delegates | CHF 1,595 | CHF 1,795 | CHF 1,895 |
Group Discount: 2nd participant get 10%, or register 3 participants and 4th participant get a complimentary seat (1 discount scheme applies)
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
- Canada: +1 833 879 8820
- USA: +1 888 745 8875
Convincing Your Boss To Attend This Program
Securing approval from your boss to attend this program can be difficult if you don’t know what to say. So we’ve prepared a template for you! All you need to do is to download this template, copy and paste in email and send it to your boss!
Certified EU Good Clinical Practice Manager (CGCP™)
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