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

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.

Understanding the required elements of the Sponsors file will enable you to have copies of essential documents ready for a monitors visit. Understanding the TMF requirements for the site and the Sponsor will ensure high quality control which will reflect well on a site being audited. You will be able to have the assurance that all of your documentation is clear and available for review. The “memo to file” will be discussed to fill in gaps found in the TMF. An electronic TMF is also feasible and this course will discuss the organization o f an electronic TMF as well.

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

Shirley Roach, is certified via SoCRA as a clinical research professional and holds a Master of Science in Health Science, Clinical Research Administration from George Washington University. She has over 30 years experience in drug development from manufacturing to clinical research.