Course Description

The Trial Master File (TMF) is a collection of the essential documents for a sponsor to demonstrate that they have fulfilled their obligations as sponsor for a clinical trial project as defined by the health authorities. This web seminar reviews the activities that a sponsor uses to set-up, maintain, and perform oversight of the TMF. It examines the changing regulatory landscape that defines sponsors responsibility in managing the TMF. This web seminar will also include handouts and discussion of the TMF Reference Model.

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Learning Objectives

• Discuss the changing regulatory climate and apply this to the TMF management practices of a sponsor of clinical trials
• Examine the required components of a TMF
• Recommend policy for managing and providing oversight to 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

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.