Live Webinar- "Trial Master File (TMF): FDA Expectations From Sponsors and Sites"

Live Webinar: Trial Master File (TMF): FDA Expectations From Sponsors and Sites When: Wednesday October 27, 2021 - 01:00 PM Duration: 90 Minutes.

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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. 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