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Archive: Trial Master File (TMF) for Sponsors: Set-Up and Maintenance
Course Description
The Trial Master File (TMF) is a collection of the essential documents for a sponsor to record how they have fulfilled their obligations as sponsor for a clinical trial project. This web seminar reviews the sponsor TMF required and additional content for a clinical trial. The activities of set-up, maintenance, and quality control and assurance will be discussed along with common deficiencies and challenges. This web seminar will also include handouts and discussion of the TMF Reference Model.
Video Preview
Learning Objectives
- Discuss the changing regulatory climate and apply this to the essential documentation practices of a sponsor of clinical trials
- Examine the required components of a TMF
- Recommend policy for the TMF
- Discuss maintenance and quality control of the TMF
Who Should Attend
- Project Managers
- Quality Assurance Personnel
- Policy Development and Maintenance Personnel
- Sponsor/CRO Personnel involved in the policy, set-up, maintenance, auditing of the TMF
Instructor
Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C.
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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.