OASIS Electronic Trial Master File Standard Technical Committee Meeting Agenda - PowerPoint PPT Presentation

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OASIS Electronic Trial Master File Standard Technical Committee Meeting Agenda

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

  2. Agenda

  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 areanow 2. Metadata Vocabulary • Terms cross-referenced to TMF RM • Published at OASIS doc’s area now 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 201406-R01 and all associated artifacts packaged together in https://www.OASIS-open.org/committees/download.php/53402/eTMF-CSD-final-201406-01.zipas 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 • New Business • Next TC Meeting – Mon July 29am-10am PST • Roll call • Review Public comments log • New business