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Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations

 

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). This webinar will help you understand in detail the new requirements for trial master files. You should attend this webinar if you are responsible for establishing or maintaining a TMF, or providing quality assurance for data included in the file.

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Areas Covered in the Session :

  • Trial Master File (TMF) background and rationale
  • Learn what content is required for a TMF for a clinical trial
  • The essential documents to include in a TMF
  • Understand how the essential documents demonstrate the conduct of the regulated activities of the investigator and sponsor
  • Organizing and maintaining a TMF
  • How to provide quality assurance for the data included
  • Standard Operating Procedure required to support TMF
  • Developing a consistent system for locating TMF documents
  • Regulatory Inspection of TMF records and Preparation
  • Industry Standards and Best Practices
  • Interactive Q&A Session

Who Should Attend:

  • Lead CRAs
  • CRA Managers
  • Project and/or Study Managers
  • Project and/or Clinical Trial Assistants
  • Clinical Operations Administrators
  • Quality Assurance Personnel
  • Compliance Teams
  • Validation Teams
  • Sponsor and CRO personnel involved in set up, maintenance, and auditing of the Trial Master File for sponsors
  • Consultants
  • Teams involved with CSV
  • Auditors engaged in the internal inspection of clinical trial documentation and practices
recording single
for 1 attendees only
recor corp
upto 10 attendees

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