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That Awkward Stage: Transition from Paper Trial Master File to eTMF
Session Chair(s)
Denise DeRenzo Lacey, MA, MS
Managing Director
Halloran Consulting Group, Inc., United States
In this session, we will explore best practices for making the transition from a paper to electronic trial master file (TMF), from the different perspectives of an eTMF vendor, a clinical operations sponsor, and an electronic document management system manager.
Learning Objective : Discuss how to structure a paper-to-electronic transition plan that includes ongoing studies while meeting regulatory needs and reducing operational impacts;Describe how TMFs differ from other files managed in an electronic document management system (EDMS);Identify best practices for partnering with an EDMS owner.
Speaker(s)
eTMF Implementatio: A Case Study
Stacy Hitchman
Biogen Idec, United States
Associate Director, Global Clinical Operations
Transitioning From Paper to eTMF
Sharon Ames
NextDocs, United States
Enterprise Program Director
eTMF Implementation: A Case Study
Krystyna Kowalczyk
Novella Clinical, United States
Executive Vice President, Clinical Operations
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