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Archive: Trial Master File (TMF) for Research Sites: Set-Up and Maintenance
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.
Video Preview
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.
