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Clara Fargo
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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...
Trial Master File - Advanced
Intermediate4.7
★★★★★
97% Recommended
Updated 2026
3 hours
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2 points
Bundle Offer: Accelerate Your Clinical Research Career - Master Good Clinical Practice (ICH GCP E6(R3)) + Fundamentals of Clinical Trials + AI in Clinical Research in one high-impact bundleYour Study Basket
1 x Trial Master File - Advanced
| Total |
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Each course includes:
CPD Points
Gain Continuing 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.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any changes to ICH GCP E6(R3), the DIA TMF Reference Model, EMA and MHRA inspection guidance and FDA Part 11 expectations, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by experienced TMF managers and clinical quality leads to ensure that learners can build and govern an inspection-ready TMF.
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About
This course is recommended for TMF managers, document specialists, study managers, project leaders and quality professionals overseeing clinical trial documentation. On completion, learners will be able to design and govern an eTMF, assess inspection readiness, lead a TMF health check, and respond effectively to sponsor and regulatory queries. Aligned with ICH GCP E6(R3), the DIA TMF Reference Model and FDA, EMA and MHRA inspection expectations.
Course Syllabus
- What the TMF Is
- Why TMF Matters
- TMF Specialist Role
- TMF vs ISF
- Reference Model Foundations
- The 12 Zones — Part 1
- The 12 Zones — Part 2
- Indexing & Naming
- Start-Up Phase
- Conduct Phase
- Close-Out Phase
- Archive & Retention
- ICH GCP E6 §8 Foundation
- Document Completeness
- Document Accuracy
- Document Types in Detail
- Documenting Gaps & Issues
- What an eTMF Is
- Metadata & Indexing
- Audit Trails & Version Control
- 21 CFR Part 11 & Annex 11
- eTMF Workflows & Automation
- Naming Conventions
- Metadata at Filing
- Version Control
- 5-Day Filing SOP
- Filing Errors & Recovery
- TMF Health Metrics
- Quality Review Processes
- Inspection-Ready Definition
- Communication & Coaching
- Role Levels
- Daily Responsibilities
- Audit & Inspection Support
- Career Path & Growth
- What Inspectors Look For
- Top 10 TMF Findings
- Inspection-Day Choreography
- CAPA Discipline
- Filing & Indexing Errors
- Document Quality Errors
- Compliance Risks
- Recovery Patterns
- Multi-Study Management
- CRO & Sponsor Partnership
- Portfolio Health Metrics
- Sustainable Practice
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