Data Quality WG - 15FEB2013

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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: 01:00-2:00 EST , 15FEB2013
Place: Teleconference
Facilitator: Lisa
Attendance: Max, Hany, Doug, DJ, Anne, Sergiy
Excused:

Agenda

  1. Previous Action Items
  2. Project Lead
  3. Steering Committee Update
  4. CSS Conference Planning
SDTM Validation Rules
Open Session Logistics

General discussion

Project lead: Hany proposed Majdoub Haloui to lead the SDTM Validation Rule project. Hany will forward project lead responsibilities to Majdoub and we will invite him to next meeting to discuss.

Steering committee update: Need to provide write up about plans for the break out session to help generate interest for the conference and put it on Wiki.

Open Session Framework/Logistics: Group discussed two additional topics for the open session.

  • Validation Rules around Site Inspection Domain (DE)
  • Quantifying OpenCDISC Validation Reports.


Action Items

Hany to forward project lead responsibilities to Majdoub Haloui and discuss role with him.

Lisa to invite Majdoub to next meeting to discuss the project lead role.

Sergiy to complete review of combined CAB/VP and Top 20 CBER rules and provide review comments by next meeting for discussion.

Lisa to draft additional open session topic ideas to include on wiki for team review.

Follow up


Last revision by LisaLyons,02/15/2013