1. OASIS Electronic Trial Master File Standard Technical Committee Meeting Agenda
June 20, 2014
9:00 – 9:30 AM PDT

2. Agenda Topic Presenter 9:00 - 9:02 Call to Order Zack Schmidt
9:02 - 9:05
Roll Call (Minutes from 6/13 in progress)
Jennifer Alpert
9:05 – 9:08
Draft Spec Status
9:08 – 9:10
Motion to adopt draft spec for public review
All
9:10 – 9:15
Outreach / Public Comment Action Items
Zack

3. Roll Call

4. Charter Objective – Publish Draft Spec for Public Review June 2014
Status:
1. Draft spec:
Available today for TC to review
Published at OASIS doc’s area now
2. Metadata Vocabulary
Terms cross-referenced to TMF RM
3. eTMF Standard Machine Code
Published at OASIS doc’s area
4. Release Notes – describes public review spec package
New

5. Motion to adopt draft spec for public review
"I move that the TC approve OASIS eTMF Standard Draft Specification R01 and all associated artifacts packaged together in  as a Committee Specification Draft  and designate the PDF version of the document as authoritative. I further move that the approved Committee Specification Draft be released for 45 day public review." 

6. Outreach / Public Comment
Activities
OASIS / TMF RM briefing – July 2
Jennifer, Michael Agard, Sharon Ames – preparing slides
OASIS-sponsored webinar briefing
To all interested - FAQ
Estimated time: June 27, with OASIS PR
Contact list – to OASIS
Agencies, Standards groups, others

7. OASIS DIA Briefing Webinar
Proposed Presentation Outline:
What is the OASIS eTMF Standard Draft Specification?
TC charter summary
Who is involved?
OASIS etc
The Challenge
The OASIS eTMF Standard offering
OASIS eTMF Standard Specification
OASIS eTMF Standard controlled vocabulary
Support for the TMF Reference model
OASIS eTMF Standard Content Model
How to access OASIS eTMF Standard Resources for Review
How to comment on the OASIS eTMF Standard Draft Specification

8. New Business & Next Meeting
Next TC Meeting – Mon July 2 9am-10am PST
Roll call
Review Public comments log
New business