Trial Master File (TMF): FDA Expectations From Sponsors and Sites
Duration : 60 Minutes
Sarah Fowler-Dixon, Clinical Research
Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new pr Read more
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. The instructor will discuss common deficiencies identified by FDA auditors during review of TMFs and provide potential solutions to the same.
This webinar 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
This webinar will provide valuable information to people investing in FDA-regulated product development projects and also the following personnel:
• Clinical Research Associates (CRAs)
• Clinical Research Coordinators (CRCs)
• Clinical Research Administrators
• Principal Investigators
• Project Managers
• Sponsors of INDs
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
