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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