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 course 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, as well as common deficiencies and challenges.
- 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
- Project Managers
- Quality Assurance
- Policy Development and Maintenance
- Sponsor/CRO Personnel involved in the policy, set-up, maintenance, auditing of the trial master file
Sandra ”SAM” Sather, MS, BSN, CCRA, CCRC
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2 hours; 12:30 - 2:30 p.m. Eastern
May 18, 2010
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.