Centralized TMF Management: The CRO Sponsor Partnership

Course Description

Many sponsor organizations transfer responsibility for Trial Master File (TMF) management to their Contract Research Organization (CRO) partners. However, the CRO maintains TMF content for those activities for which they have been delegated. Generally, a TMF is comprised of sponsor, CRO, and vendor content. The relationship between the CRO and the sponsor is critical in ensuring a quality inspection-ready TMF. This web seminar will explore critical activities and responsibilities on the part of the CRO and the sponsor. A successful partnership between these two groups is critical to ensuring an inspection ready file during and at the conclusion of the study. Both partners must understand the activities of each other to ensure that all artifacts within the TMF have been collected and are available within the TMF. A key tool in centralized TMF Management is the TMF Study Map. We will explore the process of developing and managing the TMF Study Map in tracking the content of the TMF during the active phase of the study and at completion. Use of a TMF Plan by the sponsor and the CRO will also be discussed.

Learning Objectives

• Identify the responsibilities of the sponsor and CRO for TMF Management
• Discuss the key components of the TMF Plan
• Demonstrate understanding of the key components of a TMF Study Map
• Identify strategies for managing the CRO and Sponsor relationship as it relates to the TMF

Who Should Attend

• Trial Master File Directors
• Trial Master File Managers
• Trial Master File Coordinators
• Clinical Operations Directors
• Trial Managers
• Records Management Team Members

Instructor

Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C.

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Registration Fees

$735

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 +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-22-006-L04-P. Released: 5/22. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.