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


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This training will review the essential elements of a TMF for clinical trials. The activities of set-up, maintenance, and monitoring will be discussed using case studies to highlight common deficiencies and potential solutions.

Course Objective

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.

Course Outline

  • 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

Target Audience

This webinar will provide valuable information to:
  • 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
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session




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