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Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Good Clinical Practice: Fundamentals Course & Certification
Beginner and Intermediate
4.7
★★★★★
95% Recommended
Updated 2026
3 hours
234 active users
3 points
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Each course includes:
Fully compliant
This course is an introduction to the international ICH-GCP guidelines, providing practical interpretation for those new to clinical trials. Learners also receive 3 Continual Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam doesn’t mean taking the same questions again and again.
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Our cost-effective prices represent excellent value. You can easily pay up to ten times more for face-to-face training. We can also offer generous group discounts on larger purchases.
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About
The Good Clinical Practice: Fundamentals Course is designed to provide a clear and structured understanding of ICH-GCP principles that govern the design, conduct, and reporting of clinical trials. The course focuses on ensuring participant safety, data integrity, and regulatory compliance across all phases of clinical research.
This course covers ICH-GCP guidelines, ethical principles, roles and responsibilities of stakeholders, informed consent process, essential documentation, protocol adherence, safety reporting, and inspection readiness. It also emphasizes quality assurance and best practices for conducting compliant and ethical clinical trials. Upon successful completion, learners receive a certification demonstrating competency in Good Clinical Practice fundamentals.
Who Should Enrol?
- Clinical Research Professionals
- Clinical Trial Managers and Coordinators
- Clinical Research Associates (CRAs)
- Principal Investigators and Sub-Investigators
- Regulatory Affairs and Compliance Professionals
- Pharmacovigilance and Clinical Operations Teams
- Pharmaceutical, Biotechnology, and CRO Employees
- Life Science, Pharmacy, Nursing, and Medical Graduates
What you will learn
Understand the fundamentals of clinical trials, including key concepts such as study design, placebo, roles of study teams, CROs, and the principles of ICH GCP.
Learn the essential processes of study start-up, including ethics approvals, regulatory submissions, investigator agreements, site training, and essential document management.
Gain knowledge of study conduct activities such as informed consent, patient recruitment, data collection, safety reporting, investigational product handling, monitoring, audits, and protocol compliance.
Develop an understanding of study completion activities, including database lock, study close-out procedures, and proper archiving in accordance with Good Clinical Practice requirements.
Course Syllabus
- Course Overview
- What are Clinical Trials?
- What is a Placebo Treatment?
- What is ICH GCP?
- What is a CRO?
- What is the Role of the Study Co-ordinator?
- Main Activities
- Ethics Committees
- Ethics Committee Submissions and Approvals
- Institutional Approval
- Competent Authority Approval
- Quality Management
- Investigator / Institution Agreements
- Investigator’s Brochure
- Essential Documents
- Site Training
- Site Initiation Visit
- Patient Recruitment
- Informed Consent
- Randomisation of Patients
- Patient Management & Assessments
- Protocol Deviations
- Investigational Product (Study Drug) Management
- Data Collection
- Electronic Systems
- Adverse and Serious Adverse Events
- Site Monitoring
- Frequency of Monitoring Visits
- Communication with the Sponsor
- Filing and Document Management
- Quality Assurance
- Audits
- The Monitoring Report & Plan
- Research Fraud and Misconduct
- Database Locks
- Study Close Out
- Archiving at the Site
- Glossary & Abbreviations
- Useful Resources
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