Data Quality WG - 01MAR2013

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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, Anne, Hany,
Excused: DJ, Doug, Majdoub

Agenda

  • Previous 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
  • Steering Committee Update
    Discuss email from Chris Decker sent 2/27
    4-5 Bullet agenda posted to wiki by March 8 (see proposal)
    Main session presentation due date change to March 11 --> Max
    Email communication to get attendees excited (FDA non-clinical letter sent as example) - need volunteer
  • CSS Conference Planning
    SDTM Validation Rule Project
    Validation Rules around the Site Inspection domain (DE)
    Analysis Validation Rules?

General discussion

Steering Committee Update:

  • 20 people signed up so far for Data Quality and we will be located away from conference in the hotel.
    Need to provide bullet agenda for wiki by March 8th
    - Discussed background on 2012 projects, plan for SDTM Validation Rule project. Ann suggested Max/Sergiy present Overview of OpenCDISC v1.4 udpates as separate topic. Max needs to confirm with Sergiy if it is possible.


  • Need email communication to send to all DQ attendees. Ann agreed to draft letter.


CSS Conference Planning:

  • General Session Slides - Max will use the slides from Steering committee update as basis for overview and send to team for review March 7th.


  • Working Session Slides - Hany forwarded last years working session slides. Ann will provide background slides for the CAP/VP project. Ann provided a draft for Top 20, but we need DJ to review provide more content if necessary and present the background at the working session.


  • Site Selection (DE) Update - Lisa provided update from Michael Brennan regarding the site selection (DE) domain. Goal of group was to present GAP analysis between what OSI has developed vs. available standards. The GAP analysis report will be turned over to CDISC and they will determine how to fit it within standards. It might be challenging to define validation rules for a structure that will change.
  • SDTM Validation Rule Project - We need to discuss with Majdoub to see if he can reschedule his meetings for next two weeks to attend the planning meetings. We might need to find a lead at the working session if he is unable to commit the time and effort to lead the project and participate in planning.
  • New Idea from Max - Develop Validation Rules;
    Therapeutic Area Standards
    ADaM (ADAE, Time to Event, etc.)
    Site Inspection (DE) - TBD based on above

Action Items

Ann:

  • Draft CAP/VP background slides - Done
    Draft email communication to get attendees excited - Done

DJ:

  • Review Top 20 Background slides provided by Ann and add additional detail - DJ has been nominated to provide background at the working session since he was in this group.

Hany

  • Forward working sessions slides from last year - Done

Lisa:

  • Call Majdoub to see if he can attend next two meetings.

Max:

  • Draft main session slides and send to group for review by MARCH 7th

Follow up


Last revision by LisaLyons,03/4/2013