Clinical Trial Master File (TMF) And Electronic Trial Master File (ETMF)

  • Instructor : Carolyn Troiano
  • Level : Intermediate
  • Study time : 110 minutes
  • Course ID: TF3641
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ABOUT THE COURSE

Are you responsible for maintaining critical clinical trial documents but unsure if you’re doing it the right way?
Do you want to ensure your TMF or eTMF is always inspection-ready and meets regulatory standards?
Would you like to streamline your document management system, making audits and submissions effortless?


This course simplifies TMF and eTMF management — showing you exactly what to collect, how to store it, and how to stay compliant throughout the clinical trial lifecycle.


WHAT WILL YOU GAIN
  • Clarity on what qualifies as essential documents and how to manage them
  • Practical steps to structure and maintain a compliant TMF or eTMF
  • Knowledge to prepare for audits and regulatory inspections with confidence


WHY TAKE THIS COURSE
  • TMF noncompliance is a common inspection finding and easily preventable
  • Get updated on what regulators now expect from both TMF and eTMF systems
  • This training bridges the gap between documentation, systems, and quality assurance


KEY AREAS COVERED
  • Required content and structure of a Trial Master File (TMF)
  • Managing essential documents using an eTMF system effectively
  • How TMF demonstrates clinical trial conduct by both sponsors and investigators
  • Developing SOPs and systems to support TMF data accuracy and availability
  • Best practices for organizing, locating, and preparing TMF documents for inspections
  • eTMF industry standards and regulatory expectations across jurisdictions
  • Clarity on what qualifies as essential documents and how to manage them
  • Practical steps to structure and maintain a compliant TMF or eTMF
  • Knowledge to prepare for audits and regulatory inspections with confidence


WHY TAKE THIS COURSE
  • TMF noncompliance is a common inspection finding and easily preventable
  • Get updated on what regulators now expect from both TMF and eTMF systems
  • This training bridges the gap between documentation, systems, and quality assurance


KEY AREAS COVERED
  • Required content and structure of a Trial Master File (TMF)
  • Managing essential documents using an eTMF system effectively
  • How TMF demonstrates clinical trial conduct by both sponsors and investigators
  • Developing SOPs and systems to support TMF data accuracy and availability
  • Best practices for organizing, locating, and preparing TMF documents for inspections
  • eTMF industry standards and regulatory expectations across jurisdictions

Quality training, expert insights, and answers that matter. Know your Expert

CAROLYN TROIANO

Carolyn Troiano has spent over three decades helping companies master computer system validation and electronic compliance. A trusted voice in FDA-regulated environments, she’s contributed to 21 CFR Part 11 strategy and led large-scale TMF and eTMF implementations globally. Her approach blends practical structure with regulatory precision — ideal for anyone managing clinical trial documentation.

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