Technical Committee Meeting Agenda June 9, 2014 9:00 10:00 AM PDT - PowerPoint PPT Presentation

OASIS Electronic Trial Master File Standard Technical Committee Meeting Agenda June 9, 2014 9:00 – 10:00 AM PDT

Agenda Topic Presenter 9:00 - 9:05 Call to Order Zack Schmidt 9:05 - 9:10 Roll Call and Approval of Minutes Jennifer Alpert 9:10 – 9:15 Charter Status – Draft, Public Review Zack Schmidt Timeline and Action Plan Zack Schmidt 9:15 - 9:25 Metadata Vocabulary Workgroup Status Vocab group /Jennifer 9:25 - 9:30 Technical Workgroup report Oleksiy / Zack 9:30 - 9:40 Specification Workgroup Status Editor group/Aliaa 9:40 – 9:50 Outreach Strategy / Actions, Orgs Zack/All 9:50 - 9:55 New Business All 9:55 - 10:00 Next Meeting Agenda/Date Zack 2

Roll Call Last Name Company Voting Status Present? Jennifer Alpert Palchak, Co-Chair CareLex Member/Voter Aliaa Badr CareLex Member/Voter Oleksiy (Alex) Palinkash CareLex Member/Voter Beau Grignon Forte Research Systems Member Troy Jacobson Forte Research Systems Member/Voter Member/ 2 nd mtng Mead Walker, HL7 Liaison Health Level Seven (HL7) Lou Chappuie Individual Member/Voter Lisa Mulcahy Individual Member Sharon Elcombe Mayo Clinic Member/Voter Robert Gehrke Mayo Clinic Member Tom Johnson Mayo Clinic Member Member/2 nd mtng Sharon Ames NextDocs Member/1 st mtng Prabhat Vatsal NextDocs Robin Cover OASIS OASIS Staff Contact Chet Ensign OASIS OASIS Staff Contact Rich Lustig Oracle Member/Voter Michael Agard Paragon Solutions Member/Voter Chris McSpiritt Paragon Solutions Member/Voter Jamie O'Keefe Paragon Solutions Member/Voter Fran Ross Paragon Solutions Member/Voter Member/ 2 nd mtng Peter McNaney Phlexglobal Ltd. Peter Alterman SAFE-BioPharma Assn Member/Voter Catherine Schmidt SterlingBio Member/Voter Ayrat Sadreev SureClinical Member/ 1st mtng Zack Schmidt, Co-Chair SureClinical Member/Voter Trish Whetzel SureClinical Member/Voter Stephen Scribner EMC Observer Laura Hilty Forte Research Systems Observer Tony O'Hare Forte Research Systems Observer Jill Malayang University of Michigan Observer

Meeting Etiquette • Announce your name prior to making comments or suggestions • Keep your phone on mute when not speaking • Do not put your phone on hold – Hang up and dial in again when finished with your other call – Hold = Elevator Music = very frustrated speakers and participants • Meetings will be recorded and posted – Another reason to keep your phone on mute when not speaking! • Use the join.me “Chat” feature for questions / comments • We will follow Robert’s Rules of Order From eTMF Std TC to Participants: Hi everyone: remember to keep your NOTE: This meeting is being recorded and will phone on mute  be posted on the project Wiki page after the meeting 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 • Motion to approve draft spec for public comment on 13 June 2. Metadata Vocabulary – Cross-referenced to TMF RM – Several new terms identified for addition by MD vocab workgroup • Published at Oasis doc’s area by Weds 6/11 • Please review after notification sent to TC 3. eTMF Standard Machine Code • Published at Oasis doc’s area by Weds 6/11 • Please review after notification sent to TC 4. Outreach / OASIS Marketing

DIA TMF RM OASIS webinar Proposed- OASIS Press Goal: Draft Spec, Draft By Tues 6/17 Available for Public Terms, Draft Code TC Meeting Review, 6/13 Fri 6/13 Draft Spec Publication - Proposed Timeline Goal: Draft Public Spec TC Meeting -Spec Review Mon 6/9 - MD Review Goal: Draft CSD -Code Review Charter Objective – MD Review 2 Fri 6/6 MD Review 1 Tues 6/3 TC Meeting Spec Review 1 Mon 6/2 Mon 6/2

Metadata Vocab Layer Workgroup • Confirmed Metadata Cross References to TMF RM – 331 category terms reviewed • 319 approved by group first pass • 3 new eTMF Standard terms added • 3 not used in Oasis eTMF Standard • Only 6 require final determination – 61 annotation & data properties • Selected ‘Terms Submitted to NCI’ • Final decision on 6 terms by/before Wed. 6/11

Technical Workgroup • Status:

Specification Workgroup • Status:

Outreach / Public Comment • Activities – Oasis-sponsored DIA webinar briefing – Oasis press release on draft spec comment – Direct email: • Contact list – Agencies, Standards groups, others

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

New Business & Next Meeting • New Business • Draft Agenda for TC on Friday 6/13 meeting 9am-10am PST – Roll call – Motion to adopt draft spec and publish for public review – Review intro to Oasis eTMF slides – List of public review outreach contacts – Draft Press release? From Oasis if avail – New business