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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 - Specialist Course & Certification
Intermediate
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4.7
★★★★★
96% Recommended
Updated 2026
3 hours
183 active users
2 points
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1 x Trial Master File - Specialist
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eBookWorth £29— Yours FREE when you purchase today.
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Each course includes:
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
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
The Trial Master File (TMF) – Specialist Course is designed to provide in-depth knowledge of TMF management in clinical trials, focusing on advanced practices for ensuring completeness, accuracy, and inspection readiness. It highlights the critical role of the TMF in demonstrating trial conduct, regulatory compliance, and data integrity throughout the study lifecycle.
This course covers advanced TMF structure and governance, essential document management, version control, eTMF systems, quality control processes, reconciliation activities, and inspection readiness. It also emphasizes Good Clinical Practice (GCP) requirements, sponsor and investigator TMF responsibilities, audit preparation, and risk-based TMF oversight. Upon completion, learners receive a certification demonstrating advanced competency in Trial Master File management.
Who Should Enrol ?:
- TMF Specialists and TMF Managers
- Clinical Trial Associates (CTAs)
- Clinical Research Associates (CRAs)
- Clinical Operations and Project Management Professionals
- Quality Assurance and Regulatory Affairs Personnel
- CRO and Pharmaceutical industry professionals
- Professionals involved in clinical trial documentation and compliance
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
- 📘 Bonus: Trial Master File (TMF) – Specialist eBook (Free with purchase)
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