Many sponsor organizations transfer responsibility for Trial Master File (TMF) management to their Contract Research Organization (CRO) partners. However, the CRO maintains TMF content for those activities for which they have been delegated. Generally a TMF is comprised of sponsor, CRO, and vendor content. The relationship between the CRO and the sponsor is critical in ensuring a quality TMF. This web seminar will explore critical activities and responsibilities on the part of the CRO and the sponsor. A successful partnership between these two groups is critical to ensuring an inspection ready file during and at the conclusion of the study. Both partners must understand the activities of each other to ensure that all artifacts within the TMF have been collected and are available within the TMF. A key tool in centralized TMF Management is the TMF Study Map. We will explore the process of developing and managing the TMF Study Map in tracking the content of the TMF during the active phase of the study and at completion. Use of a TMF Plan by the sponsor and the CRO will also be discussed.
- Identify the responsibilities of the sponsor and CRO for TMF Management
- Discuss the key components of the TMF Plan
- Demonstrate understanding of the key components of a TMF Study Map
- Trial Master File Directors
- Trial Master File Managers
- Trial Master File Coordinators
- Clinical Operations Directors
- Trial Managers
- Records Management Team Members
The course will be led by one of the following instructors:
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.