Data Quality WG - 08MAR2013

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Working Group Leadership

Role Names
PM Lisa Lyons
Industry Max Kanevsky, Hany Aboutaleb
FDA DJ Chhatre, Doug Warfield
Steering Committee Liaison Anne Russotto

When: 01:00pm-2:00pm (EST) , Friday
Place: Teleconference
Facilitator: Lisa Lyons
Attendance: Max, Hany, DJ, Doug, Anne


  1. Previous Action Items
  2. Max: Draft main session slides and send to group for review - Done
  3. Ann: Draft CAP/VP background slides, draft email communication to get attendees excited - Done

General Discussion

Working Group Session (March 18): 1:00-2:30pm

  • Introduction of Members - Lisa to add to slides Anne drafted
  • Working Group Session Logistics - Lisa to incorporates slides from last year
  • Background on 2012 Projects - Add individual contributors for 2012 WG - Hany to send Lisa
  • Current Plan 2013
  • Overview of OpenCDISC v1.4 Updates

Working Group Session (March 18): 3:00-4:00pm

  • Overview of OpenCDISC v1.4 Updates - Continued
  • FDA’s List of Top Issues in CDER/CBER Submissions

Working Group Session (March 19): 8:30-10:00pm, 10:30-12:00

  • Work on SDTM Validation Rule Project
  • Investigate Interest in Writing Business/Validation Rules for Other Areas;
    Therapeutic Area Standards
    ADaM (ADAE, Time to Event, etc.)
  • Wrap Up/Future Actions

Action Items

  • DJ to set up a meeting with Doug, Max and Sergiy to go over FDA’s List of Top Issues in CDER/CBER Submissions
  • Max/Sergiy to prepare OpenCDISC Updates slides if enough time
  • Lisa to send slide/email to Chris Decker and incorporate logistic slides from Hany into Anne's slide for the session. Also set up a 2nd meeting next week.

Last revision by LisaLyons,03/8/2013