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

Duration: 90 Minutes
This webinar will help participants learn what is required of a Trial Master File for a clinical trial, and will acquire a practical understanding of how these documents provide evidence for the regulated activities of the investigator and the sponsor. Also, Attendees will learn which documents are essential, and which ones are not necessary in the event of an FDA audit.
Creation and Maintenance of Trial Master File
Instructor: Sarah Fowler Dixon
Product ID: 501613
Objectives of the Presentation
This training program will help attendees understand the regulatory expectations when it comes to creation and maintenance of the TMF (Trial Master File).
  • Understand how best to create and maintain a Trial Master File for your site or clinical trial
  • Learn what the critical components of a TMF are and what the regulatory agencies expectations are
  • Have an understanding of common errors seen in TMFs
Why Should you Attend
The trial master file is a hard copy of all documentation relating to a clinical trial. It contains essential documents. When studies are conducted under ICH E6 Good Clinical Practices (GCP), this collection of documents must be presented before, during and after the trial. These documents help provide quality assurance and help researchers evaluate their compliance with GCP, federal regulations and applicable laws.

The recommended and required contents of the trial master file (TMF) continue to be a concern for clinical trial professionals. All companies and investigators conducting clinical trials in the pharmaceutical/biotech industry maintain documentation for each clinical trial. Each company has their own unique TMF structure as defined by their SOPs however many are not clear on the regulatory expectations. This course will provide participants with an understanding of the site and sponsor regulatory expectations when it comes to the TMF.

Areas Covered
  • Trial Master File (TMF): What is it?
  • Review of the required components of a Trial Master File
  • Learn how to Create and Manage a Trial Master File
  • Investigate common deficiencies
  • Essential documents required
  • ICH guidelines and Good Clinical Practice (GCP)
  • Food and Drug Administration (FDA) guidance and expectations
  • Paper or electronic trial master files - what is allowable
  • Review of Tools that can be utilized to assist with set up and maintenance of the TMF
  • Links to useful resources
Who can Benefit
This webinar will provide valuable assistance to all personnel in:
  • Human Subjects Research
  • Healthcare interested in exploring the field of Clinical Research
  • New Clinical Research Coordinator positions (1-2 years)
  • Administration in charge of Clinical Research, Clinical Research Sites
  • Contract Research Organizations, Clinical Research Associates, Regulatory Coordinators
  • Principal Investigator positions, Sub-Investigators
  • Anyone responsible for handling trial documentation or quality assurance activities
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Sarah Fowler-Dixon, PhD, CIP is an 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, 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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