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Subject: Your 15 day Public Review for eTMF v1.0 has been announced

Members of the eTMF TC,

Your 15 day public review for Electronic Trial Master File (eTMF) Specification Version 1.0 has been announced. The review ends on September 23rd. You can find the announcement at https://www.oasis-open.org/news/announcements/electronic-trial-master-file-etmf-specification-v1-0-public-review-ends-september

Note that because this is a second public review, you are only required to handle comments in material that has changed since the previous review. You have the option of course to address any comments received and that is generally good form. However, the requirement is only for changed material. 

In addition to the announcement on the OASIS web site, I have announced the review in the OASIS and eTMF LinkedIn groups and one Twitter. Feel free to retweet/share/comment/like any of these to broadcast the news further. 

As a reminder (as it has been awhile) keep in mind the OASIS requirements for handling comments [1]. Non-TC member feedback can only be submitted to the TC's comment list etmf-comment@lists.oasis-open.org. The TC must have someone subscribed to this mail list to monitor comments. All submitted comments must be acknowledged by the TC. In addition, the TC needs to maintain a log of comments received and their resolutions. The comment resolution log will need to be available when you begin your next public review. A simple comment resolution log template is available in OpenDocument [2] and Office [3] format. 

Let me know if you have any questions regarding the review or next steps.

=== Additional references:
[1] https://www.oasis-open.org/resources/tcadmin/handling-the-comments-received-during-a-public-review

[2] https://www.oasis-open.org/sites/www.oasis-open.org/files/Simple-comment-resolution-log-template_0.ods

[3] https://www.oasis-open.org/sites/www.oasis-open.org/files/Simple-comment-resolution-log-template_0.xls


Chet Ensign
Director of Standards Development and TC Administration 
OASIS: Advancing open standards for the information society

Primary: +1 973-996-2298
Mobile: +1 201-341-1393 

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