Trial Master File (TMF) for Research Sites: Set Up and Maintenance

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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.

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


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

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Registration Fees


Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE#: 0778-0000-12-033-L01-P. Released: 6/12. 

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.