Trial Master File (TMF) for Sponsors: Set Up and Maintenance June 2010

Course Description____________________________

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.

Learning Objectives____________________________

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

Who Should Attend ____________________________

Project Managers
Quality Assurance
Policy Development and Maintenance
Sponsor/CRO Personnel involved in the policy, set-up, maintenance, auditing of the trial master file

Instructor ____________________________________

Sandra ”SAM” Sather, MS, BSN, CCRA, CCRC

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Course Length and Time________________________

2 hours; 12:30 - 2:30 p.m. Eastern

Course Dates _________________________________

June 16, 2010

Fee__________________________________________

$695

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.

Accreditation__________________________________

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2.0 hours (0.20 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: 03/10.