Checkout 0
Training Courses - Web Seminar Archives

Purchase the recording of a web seminar you have attended in the past and SAVE 50%! Contact Barnett Customer Service for details: +1 781.972.5400 or toll-free in the U.S. at 800.856.2556.

Web Seminar Archives provided through Barnett’s Learning Management System (Single User access) or by electronic file transfer (Site License).

Site license archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.

Bulk Archive access is available via Barnett’s Training Subscription. Click here to learn more.

Archive: eTMF Quality Oversight: A Risk-Based Approach

Course #: BI14039
September 11, 2020

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.

Video Preview


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


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

Click here for complete trainer biographies


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