Alignment with TMF Reference Model

["Polonsky, June" <June.Polonsky@iconplc.com>]

I am very concerned about alignment between the OASIS standards and the TMF Reference Model.  My company as well as hundreds of others have adopted the TMF Reference Model, we have also participated in the development of the model, and have adopted the standards from the model into our eTMF software.  Significant changes from the current structure or the artifact list itself will create many additional hours of unexpected work and will also put at risk the hundreds of hours of work that were put into the TMF Reference Model standards. 

 

Thank you,

June Polonsky

 

June Polonsky
Associate Director, Document Management
ICON Clinical Research

Internal Tel: 7201-3441
External Tel: +1 215-616-3441
Mobile: +1 215-715-6244
Email: June.Polonsky@iconplc.com
Web: www.iconplc.com

 

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