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

Sarah Fowler-Dixon
Mar 20, 2018 - 01:00 PM EST
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$249

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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
Attend Live Webinar
Mar 20, 2018 - 01:00 PM EST

Duration: 90 Minutes

Single Registration

Premier pro price: $199 (save 20%)

Group of 3 to 5

Premier pro price: $319 (save 20%)

Group of 6 to `10

Premier pro price: $359 (save 20%)

Training CD-DVD

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

Premier pro price: $399 (save 20%)

Recorded video

Recorded video session

Premier pro price: $279 (save 20%)


Speaker: 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 program. She has initiated the planning, development, authorship and implementation of many human subjects’ research policies, practices, guidelines, and submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she led a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook. Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.


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