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Archive: Trial Master File (TMF) for Sponsors: Set-Up and Maintenance
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.
- 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
Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.