Comments re: OASIS TMF Technical standard specifications

[Linda James <linda.james@biogenidec.com>]

Dear Oasis Team

 

Please remember that when authoring this specification document and matching industry vocabulary, that it is imperative to get alignment between the TMF Reference Model and the OASIS eTMF Model, so that for every TMF Reference Model artefact, there is a related entry in the OASIS Model. The TMF Reference model is the collaborative work of over 350 people from around 200 companies, and is implemented in slight variations within many CRO, Biotech and Pharma companies. The impact that this specification would have on the eTMF systems currently in place needs to be considered more carefully and with more in depth research.

 

 

Many thanks & kind regards

 

Linda James | Senior Specialist, GCO Document Quality, Process & Operations

Quality Operational Capabilities

Biogen Idec Limited, Innovation House, 70 Norden Road, Maidenhead, SL6 4AY, UK

Email: linda.james@biogenidec.com

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