Your Public Review for Electronic Trial Master File (eTMF) Specification

Subject: Your Public Review for Electronic Trial Master File (eTMF) Specification Version 1.0 has been announced

Members of the OASIS Electronic Trial Master File (eTMF) Standard TC,

Electronic Trial Master File (eTMF) Specification Version 1.0 CSD01 and the Public Review version CSPRD01 have been loaded to the OASIS Library and your 45 day Public Review has been announced. The review ends on August 8th. You can find the announcement at https://www.oasis-open.org/news/announcements/45-day-public-review-for-electronic-trial-master-file-etmf-specification-version-

The parties included for notification in your public review request have been bcc’ed on the announcement from OASIS.

Please 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.

For your information, the documents can be found here:

Electronic Trial Master File (eTMF) Specification Version 1.0

Committee Specification Draft 01

20 June 2014

http://docs.oasis-open.org/etmf/etmf/v1.0/csd01/etmf-v1.0-csd01.pdf

http://docs.oasis-open.org/etmf/etmf/v1.0/csd01/etmf-v1.0-csd01.html

http://docs.oasis-open.org/etmf/etmf/v1.0/csd01/etmf-v1.0-csd01.doc

OWL RDF/XML: http://docs.oasis-open.org/etmf/etmf/v1.0/csd01/owl/etmf.owl

Metadata vocabulary:http://docs.oasis-open.org/etmf/etmf/v1.0/csd01/vocabulary/

Electronic Trial Master File (eTMF) Specification Version 1.0

Committee Specification Draft 01 / Public Review Draft 01

20 June 2014