Instructions for public review of vocabulary

Ahead of the initiation of the 45-day public review period for the proposed eTMF vocabulary, I have been reviewing the draft Release Notes (dated June 13). These notes include the following statement:

“Items marked in pink highlight are terms that are in review by the Oasis eTMF Standard Technical Committee and are open for comments, suggestions during the public review process.”

This statement gives the impression that items not highlighted in pink are therefore NOT open for comment or suggestions as part of the public review. My understanding is that irrespective of whether the items are standard NCI published terms or not, all items included in the vocabulary are subject to public scrutiny and comment. If so, the quoted sentence could be misinterpreted.

Perhaps you would consider clarifying the statement in the release notes when the announcement of the public review period is made.

Kind regards,

Eldin.

Eldin Rammell

Managing Director, RAMMELL Consulting Ltd

Office: +44 (0)844 8844926 Direct dial: +44 (0)1905 617 716 Mobile: +44 (0)7940 859721

IM Skype: eldin.rammell

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