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.

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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.