SM
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
4.7
★★★★★
97% Recommended
Updated 2025
3 hours
202 active users
3 points
Your Study Basket
1 x Good Clinical Practice: Fundamentals
| Total | £0 |
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.
Affordable
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
This course is intended as an introduction to clinical trials for site staff who are new to clinical research and those from a non-clinical background. It focuses on the practical aspects of conducting phase II or III clinical trials at a site
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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