Event:
-
Trial Master File (TMF) for Research Sites: Set-Up and
Maintenance
- 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
- Website:
-
Visit the website for detail info