Data Quality WG - 22FEB2013

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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, Sergiy, Hany, Anne, DJ and Doug


  1. Previous Action Items
  2. Project Lead Role - Discuss with Majdoub Haloui Roles and Responsibilities
  3. Steering Committee Update
  4. CSS Conference Planning
  • SDTM Validation Rule Project
  • Validation Rules around the Site Inspection domain (DE)
  • Quantifying OpenCDISC Validation Reports

General discussion

Project Lead Role: Majdoub Haloui was not able to attend, but Max spoke with him and feels he understands the roles and responsibilities of the role. We will invite him to the conference planning meetings.

Steering Committee Update: Use slide template, stay within 15 min and say thanks to volunteers. Max will draft slides and send by March 7th to group for review. Group was curious how many registered for WG1. Anne will ask.

Conference Planning:

  • SDTM Rule Project - Sergiy went over comments from his review. We have approximately 16 rules still open. Goal is to add 10 to 15 more based on feedback from FDA and current data project. Max, DJ and Doug will provide us with the additional rules.

Tenative schedule for the SDTM Rule Project working session. There were no objections to the agenda.

  • SDTM Validation Rule Project Agenda
  • Background on 2012 Projects
    CAP/VP and OpenCDISC Rules Reconciliation Project
    CBER Top 20 Validation Rule Failures
  • Current Plan 2013
    Creation of updated SDTM Validation Rule list based on following;
    Combination of CAP/VP + CBER Top 20
    Elimination of resolved issues with latest version of OpenCDISC v1.4
    New list of rules generated from FDA project
  • Working Session
    Categorize rules into ???
    Wrap-Up (March 19)
  • Breakout groups report progress
  • Future Steps

  • Validation Rules around the Summary Level Clinical Site Dataset (DE) - The group felt this is of value but would like to know what happened with legacy work group Michael Brennan was leading to ensure there is not duplication of effort. Lisa will follow up with Michael. Doug said he or DJ would be willing to lead this effort at the conference.

  • Quantifying OpenCDISC Validation Reports - The majority felt this might be too complicated to tackle for this work group at this time.

  • Additional topic of analysis validation rules was brought up. Some discussion around collecting the business requirements, expectations. Some felt it might be more of a "think tank" concept and less concrete project. Need to discuss futher.

Action Items

  • Draft slides for open session send to team by March 7th - Max
  • Find out how many people registerd for data quality WG - Anne
  • Invite Majdoub to planning meetings until conference - Lisa
  • Find out from Michael Brennan status of work group that worked on site selection last year - Lisa

Follow up

Last revision by LisaLyons,02/22/2013