TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings June 2019

Jun 21, 2019
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Course Description

When applied to electronic Trial Master File (eTMF) oversight, risk-based management is the combination of the potential of quality issues occurring and the impact these deficiencies may have on the integrity of the TMF and the overall Good Clinical Practice (GCP) impact on the study. The TMF is comprised of many records and documents, and a quality TMF is defined as a collection of records, which is complete, collected in a timely manner and comprised of quality records. In the past several years, regulatory agencies have been very clear in their expectation that a sponsor presents a quality TMF during an inspection. This web seminar will examine the concept of a risk-based approach to TMF management and oversight, and, its application to TMF oversight. Included are processes for conducting and documenting quality control (QC) activities that will ensure a high quality eTMF. Quality review findings can then drive the need for additional quality review activities, and by applying these concepts, the sponsor ensures TMF inspection readiness.

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Learning Objectives

  • Discuss the application of risk-based assessment to establish a plan for conducting eTMF QC activities
  • Explain various QC activities to ensure a high quality eTMF
  • Identify key TMF artifacts with significant risk for quality issues

Who Should Attend

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

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.