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About

The Clinical Study Coordinator Course by Whitehall Training provides a comprehensive foundation for entry-level professionals and focuses on the practical execution of clinical trials within the framework of Good Clinical Practice. Core content typically covers GCP fundamentals (principles, ethics, and regulatory requirements), the global regulatory landscape and ethics committee oversight, investigator and sponsor responsibilities, and clinical trial documentation and data integrity (including ALCOA+ principles, source data, CRFs, and site files). It also includes safety and pharmacovigilance processes (AE, SAE, and SUSAR reporting), protocol understanding and trial conduct, monitoring and site operations (including CRA roles and source data verification), and data governance using electronic systems and audit trails. Additional topics include informed consent procedures, investigational product management, quality and risk-based approaches, and study close-out and record retention. These topics are drawn from international guidelines – notably ICH-GCP E6(R3) and related regulatory frameworks. The course emphasizes practical, inspection-ready skills (e.g. maintaining study documentation, supporting informed consent, managing safety reporting, and ensuring protocol compliance) in line with global regulatory standards.

Course Syllabus

  2. What Is the Trial Master File?
  3. The Regulatory Framework for TMF
  4. Essential Documents by Trial Phase
  5. TMF Deficiencies: Consequences and Real Cases
  6. The PI's Role in TMF Excellence?
  7. TMF Archiving and Retention
  8. Building a TMF Culture at Your Site
  9. Practical Application and Knowledge Checks
  10. Module Summary and Action Planning

  1. ALCOA+: The Golden Standard for TMF Documentation
  2. Source Document Standards for Clinical Trials
  3. Document Creation, Version Control, and Filing
  4. Filing Standards and Document Management
  5. Monitoring Visits and TMF Population
  6. Protocol Deviations and the Deviation Log
  7. Drug Accountability Documentation
  8. Adverse Event Documentation
  9. Subject Records and Subject Identification
  10. Module Summary and Action Planning

  1. Understanding What Inspectors Look For in the TMF
  2. TMF Self-Inspection: The Completeness Methodology
  3. TMF Health Metrics: Completeness, Timeliness, and Quality
  4. Pre-Inspection Preparation: A Site Action Plan
  5. During and After the Inspection
  6. Common TMF Inspection Findings and Root Causes
  7. TMF Quality Metrics and Continuous Improvement
  8. Mock Inspection: Practical Preparation
  9. Module Summary and Action Planning

  1. From Paper to Digital:The eTMF Revolution
  2. Regulatory Requirements for Electronic Records
  3. eTMF Best Practices for Site Teams
  4. Remote Inspections:The New Standard
  5. Hybrid TMF: Managing Paper and Electronic Records Together
  6. Inspector Access to eTMF: Practical Protocols
  7. eTMF Metrics, Dashboards,and Continuous Quality
  8. eTMF Archiving and Long-Term Records Management
  9. Future-Proofing Your eTMF Programme
  10. Module Summary and Course Conclusion

Our Certified Customers

novartis
NHS
takeda
roche
baxter

Learner Rating & Reviews

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RC

Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

SM

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...

Frequently Asked Questions

The TMF Excellence Course by Whitehall Training provides a high-level mastery of Trial Master File architecture, transitioning from basic document storage to inspection-ready reconstruction. It combines the rigorous regulatory requirements of ICH-GCP E6(R3) with the practical application of the DIA TMF Reference Model, ensuring that clinical research professionals can maintain data integrity and trial oversight throughout the study lifecycle.

  • The fundamentals of clinical research and trial phases and core responsibilities and day-to-day tasks of a CRA
  • Key ICH GCP E6(R3) principles and regulatory expectations
  • How to prepare for and conduct monitoring visits
  • Risk-based and remote monitoring approaches
  • Investigational Product (IP) oversight and accountability
  • Safety reporting requirements (AE/SAE/SUSAR)
  • Site communication, documentation, and issue escalation
  • Close-out procedures and essential record archiving

This course is ideal for individuals who want to begin or advance a career in clinical research, including:

  • Aspiring Clinical Research Associates (CRAs)
  • Clinical trial site staff transitioning into monitoring roles
  • Clinical Research Coordinators (CRCs) seeking career progression
  • Professionals working in pharmaceutical, biotech, or CRO environments
  • Anyone seeking a strong foundation in monitoring, GCP, and site oversight .
No prior CRA experience is required, but familiarity with clinical research or GCP is helpful.

  • Industry-aligned CPM training with global recognition
  • Fully updated to ICH GCP E6 (R3) requirements
  • Ideal for aspiring CPMs and those transitioning from site roles
  • Practical, scenario-based learning to build real-world confidence
  • Certificate issued upon successful completion