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Archive: TMF/eTMF Audit Strategies

Course #: BI14651
October 15, 2021

Course Description

The process for managing the Trial Master File (TMF) has changed drastically in the last 10 years. Many organizations have moved to an electronic TMF (eTMF), yet some organizations still operate with a paper TMF or a hybrid of the two. A successful audit evaluates the completeness of the entire TMF. This web seminar will present a strategy for conducting a TMF audit that identifies gaps that have potential impact on the quality of the TMF. We will explore strategies for using the power of an eTMF to identify gaps that could result in inspection findings. The power of the TMF Reference Model in organizing the audit and identifying key artifacts that potentially impact Good Clinical Practice (GCP) compliance will also be discussed. Finally, we will examine strategies for the audit of a paper TMF as well as an eTMF, including critical files to review and how to spot trends in non-compliance.

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Learning Objectives

  • Explain the value of the TMF Reference Model in organizing an audit to ensure efficient identification of GCP non-compliance
  • Identify strategies for conducting an audit of an eTMF that employ the enhanced capabilities of an eTMF
  • Identify strategies for auditing a TMF that focuses on artifacts impacting the quality and GCP compliance of the TMF/eTMF

Who Should Attend

  • Good Clinical Practice Auditors
  • Trial Master File Directors
  • Trial Master File Managers
  • Trial Master File Coordinators
  • Clinical Operations Directors
  • Trial Managers
  • Records Management Team Members


Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C. 

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.