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

  • ID: 3785814
  • Webinar
  • 90 Minutes
  • Online Compliance Panel
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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.

Participants will 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.

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 present 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.

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
Note: Product cover images may vary from those shown
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- 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
Note: Product cover images may vary from those shown
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  • Sarah Fowler-Dixon Sarah Fowler-Dixon,
    Education Specialist and instructor ,
    Washington University


    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, 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 lead 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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  • 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
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