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Trial Master File (TMF): FDA Expectations from Sponsors and Sites
The first document FDA auditors review during the audit of a clinical site is the Trial Master File (TMF).
The regulations describe the various kinds of documentations that an investigator needs to maintain to demonstrate compliance. Sponsors are required to assure site compliance with the protocol tasks, training and provide any resources necessary to assist site’s ability to perform their tasks. The TMF not only acts as a warehouse for all the study-specific documents, but also acts a tool for quality control and quality assurance.
This webinar 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.
Why Should you Attend:
If you involved in a clinical trial, either as a clinical site or a sponsor, this seminar will provide valuable suggestions about which documents are essential and which ones are not needed for an FDA audit. Common deficiencies identified by FDA auditors during review of TMFs will be discussed with potential solutions to the same. Also discussed will be issues related to the kind of products being tested, responsibilities of individuals, resources available, and projected trends for the near future.
Objectives of the Presentation:
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
Who can Benefit:
This webinar will provide valuable information to:
Clinical Research Associates (CRAs)
Clinical Research Coordinators (CRCs)
Clinical Research Administrators
Sponsors of INDs
People investing in FDA-regulated product development projects