Trial Master File Fundamentals Training

Join this 2-day interactive course where all of the basics of the management of the trial master file (TMF) will be reviewed.

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Upcoming Dates

August 24–25, 2022

Quick Overview

Attendee will be provided an overview of what a TMF is and will contribute to discussions regarding what makes it up and why, who creates it and where it is located, how it is checked for completeness, and how it is audited/inspected. The TMF Reference Model and how it is used to define and organize the TMF will be reviewed. A discussion of the processes that outline the management of the TMF will be included, as well as whether risk-based approaches can be taken while still maintaining a level of confidence of its timeliness and inspection-readiness.

Who Should Attend

This training course is designed for anyone new to TMF or looking for a refresher course, including:

  • Trial Master File professionals (TMF Managers, TMF Specialist, TMF Document QC)
  • Clinical Study Assistants/Clinical Research Associates
  • Quality Compliance/Assurance
  • Project Managers/Leaders
  • Process Development processionals
  • Clinical Research professionals
  • Clinical Trial Investigators
  • Regulatory Compliance Associates

Key Learning Objectives

  • Overview of what is a TMF, noting available regulatory guidance
  • Review & use of the TMF Reference Model
  • Examine the required components of a TMF process and create a process flow
  • Review how the regulatory climate is changing and its impact to TMF management
  • Examine the pros and cons to paper, hybrid, and electronic TMFs
  • Discuss the suite processes required for the complete TMF management process
  • Review the quality control parameters for TMF content
  • Discuss risk-based approaches for quality and completeness of the TMF audits and inspections
  • Anticipate/address the pain points for establishing a compliant TMF management process