Optimizing the Use of Data Standards 2013 Meeting Minutes

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10 APR 2013

Action Items

  • Each Project needs to update/finalize their overall plan on the Wiki
  • Jeff to send documents discussed today
  • Project Leads need to fill out a Quarterly Status Report for their projects and submit to Jeff no later than May 3rd
  • Jeff to reach out to Joanna regarding SDTM Data Submission Exceptions

General Discussion Ponts

  • Review Best Practices including Scope and Objectives
    • Some principles to keep in mind:
    • Small is beautiful. Projects should be broken into the smallest bit/projects possible.
    • Quick and small pilots. Quick wins, fail fast.
    • Interim milestones for momentum and demonstration of value.
  • Quarterly Status Report
    • Topics reviewed
      • Project Status Summary
      • Project Milestone Status
      • Project Issue Summary
      • Project Risk Summary
      • Assistance Requests
      • Miscellaneous Project Notes
  • Wiki Updates
    • Project leads need to ensure that the site is being updated on a regular basis
  • Communication Strategy
    • Provide regular overview of the working successes, call for input, or other information. Goal is to continue communication within the Working Groups and Externally
  • PhUSE is working with with PharmaSUG
    • Scott to provide slides for SDRG
    • Jingyee to provide slides for Traceability
  • Update from Project Leads
    • Analysis Data Reviewer’s Guide – Susan provided an overview of activities that occurred at the conference as well as planning efforts going forward
    • SDTM Data Submission Exceptions – Jingyee mentioned that this is a fast moving project the list of exceptions have been defined. Next steps are to share with other WG and the PhUSE community for feedback
    • CDRH Pilot for the Electronic Submission of Medical Device Data in an SDTM-Based Format – Ted mentioned that he is struggling to get sponsor participation (most seem to lose interest because the mandate is several years away) and is looking for contacts for Software providers that he can reach out to get their involvement
    • Traceability and Data Flow of Study Level Data – Paul B. stated they have divided into 4 sub-groups team Leads will be responsible for coordinating each groups activities. First deliverable is the current state analysis

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