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
Who Should Attend
Instructor
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.