Course Description

Across the industry, organizations are moving towards an electronic Trial Master File (eTMF). Moving from a paper TMF or CRO-held TMF to a sponsor-held eTMF is a large undertaking for any organization. The right approach to the project is critical to the implementation. In this web seminar, we will discuss the key activities including vendor selection, developing eTMF management processes that ensure a high quality TMF, implications of eTMF within your organization, system validation, and working with business sponsor partners during the implementation process. Successful planning and implementation will result in a high-quality eTMF system that ensures the organization is inspection and audit ready.

Learning Objectives

• Identify the key processes impacted by an eTMF implementation
• Describe three techniques for addressing the functional area impact of eTMF implementation
• Develop a list of user requirements to assist in the selection of an eTMF vendor
• Discuss the strategies for communicating with business partners in the implementation of an eTMF
• Discuss the validation requirements when implementing an eTMF

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

The course will be led by one of the following instructors:

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

Jim Markley 

Linda Wiggins, MBA

Click here for complete trainer biographies

Registration Fees

$835

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 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 issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-048-L99-P. Released: 11/24.  

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