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  • Trial Master File (TMF) for Research Sites: Set-Up and

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Friday - Jul 19, 2013 10:00 AM
  • End Time:
  • Friday - Jul 19, 2013 11:00 AM
  • Location:
  • Online
  • This clinical compliance webinar will discuss the elements of a Trial Master File (TMF) and show how to set-up and maintain the TMF to ensure it can pass inspection by a clinical trial monitor or auditor.

    Why Should You Attend:

    - How would you handle missing elements of a regulatory file?
    - Who is responsible for which essential elements in a TMF?
    - How do you handle versioning of protocols in a TMF?

    This course will go over the essential documents which make up the Trial Master File. The presenter will help you understand the fundamentals of the set-up and maintenance of the TMF so you can ensure that when a monitor or auditor visits, the appropriate documentation will be easily located and you will be assured that you have all the documentation required.

    Areas Covered in the Webinar:

    - ICH guidelines and Good Clinical Practice (GCP)
    - Organization of the TMF
    - How to write good Memos for TMF
    - Versioning in a TMF
    - Access and control of the TMF
    - Staff responsibilities of the TMF
    - Long term storage of the TMF
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