Course Description

Across the industry, organizations are moving towards an electronic Trial Master File (eTMF). Moving from a paper TMF to an 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, and working with Contract Research Organizations (CROs) and 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.

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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

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.

Click here for complete trainer biographies

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