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

▶
technical committee
SMART_READER_LITE
LIVE PREVIEW

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

Nov 22, 2023 400 likes •537 views

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

slide-1
SLIDE 1

OASIS Electronic Trial Master File Standard Technical Committee

Meeting Agenda

June 9, 2014 9:00 – 10:00 AM PDT

slide-2
SLIDE 2

Agenda

2

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

slide-3
SLIDE 3

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 Mead Walker, HL7 Liaison Health Level Seven (HL7) Member/ 2nd mtng 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 Sharon Ames NextDocs Member/2nd mtng Prabhat Vatsal NextDocs Member/1st mtng 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 Peter McNaney Phlexglobal Ltd. Member/ 2nd mtng 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

slide-4
SLIDE 4

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

NOTE: This meeting is being recorded and will be posted on the project Wiki page after the meeting

From eTMF Std TC to Participants: Hi everyone: remember to keep your phone on mute 

4

slide-5
SLIDE 5

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

Charter Objective – Publish Draft Spec for Public Review June 2014

slide-6
SLIDE 6

Charter Objective – Draft Spec Publication - Proposed Timeline

MD Review 1 Tues 6/3 MD Review 2 Fri 6/6 TC Meeting Mon 6/9 Goal: Draft CSD TC Meeting Mon 6/2 TC Meeting Fri 6/13 Goal: Draft Public Spec Spec Review 1 Mon 6/2

  • Spec Review
  • MD Review
  • Code Review

Goal: Draft Spec, Draft Terms, Draft Code Available for Public Review, 6/13 OASIS Press By Tues 6/17 DIA TMF RM OASIS webinar Proposed-

slide-7
SLIDE 7
  • 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

Metadata Vocab Layer Workgroup

slide-8
SLIDE 8
  • Status:

Technical Workgroup

slide-9
SLIDE 9
  • Status:

Specification Workgroup

slide-10
SLIDE 10
  • Activities

– Oasis-sponsored DIA webinar briefing – Oasis press release on draft spec comment – Direct email:

  • Contact list

–Agencies, Standards groups, others

Outreach / Public Comment

slide-11
SLIDE 11

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

OASIS DIA Briefing Webinar

slide-12
SLIDE 12
  • 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

New Business & Next Meeting