Pooling WHODrug B3 Meeting Minutes October 2017

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2017-10-18

Agenda


  • Review Key Differences between WHODrug B2 and B3


  • Discuss possible high-level strategies for Data Pooling




Attendees


  • Wendy Dobson
  • MaryAnn Huffert
  • Malin Jakobsson
  • Joyce Leflar
  • Diane Piper
  • Marlo Searcy
  • Changhong Shi
  • Lori VanMeter
  • Siva Vobhilineni
  • Vera Voloshin



Not Present:

  • Deb Bauer
  • Mary Bethala-Pinninti
  • Greg Campbell
  • Susan Kenny
  • Amy Klopman
  • Shannon Labout
  • Jane Lozano
  • Mercy Navarro
  • Laura Savard
  • Lauren White
  • James Zuazo



Meeting Discussion


  • Attendees reviewed key differences between WHODrug B2 Format and B3 Format (see Kick-off slides)


  • Attendees discussed possible high-level strategies for data pooling


  • Companies may have different approaches to QLAB naming conventions


  • Johnson & Johnson used UMC CAT tool to create a WHODrug B3 synonym list from their B2 format synonym list (~18,000 terms). Experience was that UMC suggested replacement term for deleted dictionary entries was generally accurate.


Action Items


  • Working group members to gather information about pooling strategy at their own organization and be prepared to share any additional pooling options for consideration at November meeting


  • Working group members to gather information about how WHODrug variables and ATC Classification information is/is planned to be modeled at their organization for SDTM compliant submission and be prepared to share at November meeting


  • Marlo will provide Wendy a list of new meeting attendees, and Wendy will ensure that they have access to the PhUSE teamwork site


  • Marlo/Joyce will work with Wendy and explore tools for document collaboration to support white paper development


Upcoming Agenda Topics


  • Discuss additional pooling options (if any)


  • Determine pooling options to include in the draft white paper and any order of preference if applicable


  • Informal sharing around each company’s approach to WHODrug variable and ATC data model for SDTM submission


  • Next steps to start drafting white paper