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Subject: Public review comments for etmf-v1.0-csprd01: B.2.2 Domain based Metadata (eTMF Domain Example)


Comment type [editorial]

Impact [minor]

 

The scope of the draft specification and scope of the OASIS TC is very specifically limited to the trial master file. It is therefore not understood why the first sentence in this section has been included as it has no relevance to the topic:

 

“Note that the OASIS eTMF model can support other domains in life sciences or healthcare such as research and development, finance, administration, or others.”

 

This statement adds no value and could result in confusion.

 

Eldin Rammell,

Principal Consultant, Rammell Consulting Ltd.



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