TMF Ref Mod Comments

[Josh Myers <JMyers@tornier.com>]

I was only able to review the first couple sections.  My comments in those sections are attached.  Overall, it appears that there isn’t complete alignment with the TMF Reference Model (RM).  There are sections that have been deleted or lumped into other categories which is not appropriate.  As a user of the TMF RM, I am concerned that not all the artifacts in the TMF RM are available in the Oasis standard.  Please ensure all artifacts are represented prior to moving forward with the Oasis Standard.

 

Joshua Myers, MS, CRCP

Clinical Study Manager

10801 Nesbitt Ave South

Bloomington, MN 55437 USA

Office: 952-921-7119

Cell: 612-325-0226

Fax: 952-426-7601

Email: josh.myers@tornier.com

www.tornier.com 

 

THE INFORMATION CONTAINED IN THIS TRANSMISSION IS CONFIDENTIAL AND PROPRIETARY TO TORNIER, INC. AND INTENDED FOR THE USE OF THE INDIVIDUAL OR ENTITY NAMED ABOVE. IF THE READER OF THIS MESSAGE IS NOT THE INTENDED RECIPIENT, YOU ARE HEREBY NOTIFIED THAT ANY DISSEMINATION, DISTRIBUTION OR COPYING OF THIS COMMUNICATION IS STRICTLY PROHIBITED. IF YOU HAVE RECEIVED THIS ELECTRONIC MESSAGE IN ERROR, PLEASE NOTIFY THE SENDER BY REPLY E-MAIL AND DESTROY THE ORIGINAL MESSAGE AND ALL COPIES!

Attachment: Oasis-eTMF-Metadata-Vocabulary-Spreadsheet-201406-R01_comments.xls
Description: Oasis-eTMF-Metadata-Vocabulary-Spreadsheet-201406-R01_comments.xls