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Trial Master File (TMF): FDA Expectations From Sponsors and Sites

Summary

  • FDA’s expectation from site and sponsor’s documents
  • Required components of a TMF
  • Best practices for the set-up and maintenance of TMF
  • Electronic and Paper TMF requirements
  • Common errors in TMF management

Overview

If you are involved in a clinical trial, either as a clinical site or a sponsor, this webinar will provide valuable suggestions about which documents are essential and which ones are not needed for an FDA audit. We will discuss common deficiencies identified by FDA auditors during review of TMFs and provide potential solutions to the same. We will also discuss issues related to the kind of products being tested, responsibilities of individuals, resources available, and projected trends for the near future.

Who should attend?

  • Clinical Research Associates (CRAs)
  • Clinical Research Coordinators (CRCs)
  • Clinical Research Administrators
  • Principal Investigators
  • Project Managers
  • Sponsors of INDs
  • People investing in FDA-regulated product development projects

Marina Malikova

Expert

Dr. Malikova has over 15 years of experience in the clinical research field.  She has managed Phase I – IV studies involving investigational drugs, devices, biologics and combination products.  She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.

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