Course Description

The investigator Trial Master File (TMF) is a collection of the essential documents for an investigator to record how they have fulfilled their regulatory obligations for a clinical trial project. This web seminar reviews the investigator 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.

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Learning Objectives

• Discuss the changing regulatory climate and apply this to the essential documentation practices of an investigator of clinical trials
• Examine the required components of an investigator TMF and recommend policy
• Discuss maintenance and quality control of the TMF
• Describe the Clinical Research Associate (CRA) contributions to and adequate monitoring of the investigator TMF

Who Should Attend

• Research Site Personnel involved in the set-up and maintenance of any TMF or in charge of policy development and maintenance
• Principle Investigators
• Clinical Research Coordinators
• Clinical Research Associate Managers
• Clinical Research Associates
• Quality Assurance Personnel of research sites and sponsors

Instructor

Gary B. Freeman, M.S., C.C.R.A.

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