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; 12:00 - 2:00 p.m. Eastern
August 5, 2010
$795
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, call 1-800-856-2556 for pricing.
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#: 778-000-09-001-L04-P. Released: 3/09.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.