Pooling WHODrug B3 Meeting Minutes March 2018

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2018-03-21

Agenda


  • Finish discussing initial white paper draft and adjudicate any remaining changes


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



White Paper Draft gDoc Instructions



White Paper Draft gDoc Link: https://docs.google.com/document/d/131XoHMd4ykSGvKzMGd8Xbarkfop58ovbSr5w7m9wi0k/edit?usp=sharing



1. After opening gDoc, please change from 'Editing' mode to 'Suggesting' mode in top right corner. This will allow changes to be tracked for group review.

2. Select drop-down for 'Editing' in top right corner:

Change Editing Mode Top Right Corner


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3. Switch to 'Suggesting' in top right corner:

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4. Specify your name/initials in comment fields (otherwise, comments will be marked as Anonymous if not signed into a google account).


Attendees

  • Wendy Dobson
  • Joyce Leflar
  • Veena Nataraj
  • Laura Savard
  • Marlo Searcy
  • Changhong Shi
  • Nikolaos Sitaridis
  • Vera Voloshin



Not Present:

  • Deb Bauer
  • Mary Bethala-Pinninti
  • Greg Campbell
  • Sybille Goetz
  • MaryAnn Huffert
  • Malin Jakobsson
  • Susan Kenny
  • Amy Klopman
  • Shannon Labout
  • Jane Lozano
  • Mercy Navarro
  • Diane Piper
  • Lori VanMeter
  • Siva Vobhilineni
  • Lauren White
  • James Zuazo

Meeting Discussion


  • Attendees finished discussing initial white paper draft and adjudicated remaining changes


  • Attendees agreed that term examples should be added for options 2,3,4


  • Attendees continued to share SDTM modeling approach for WHODrug fields in CM domain:


  • Boehringer Ingelheim: Use SUPPQUAL for the additional ATC classes. When a drug has multiple ATC classes, all ATCs in SUPPQUAL are linked to a generic name in the parent domain. The CMCLAS and CMCLSCD variables in the parent domain will contain the word “MULTIPLE”. Do not manually select a single ATC class.


  • Medidata Coder tool constraint: Coder selects generic-ATC Class combination, not possible to select generic only


  • The next PhUSE steering committee meetings where white paper would be discussed are April 6th and April 20th


Action Items


  • Marlo will update Options 2,3,4 with term examples


  • Working Group Participants will review examples and provide any additional feedback by Wednesday, March 28th.


  • Marlo will send final white paper draft to Jane Lozano and Lisa Brooks on Thursday, March 29th (cc Wendy). Hopefully this provides sufficient time for them to review prior to the April 6th steering committee meeting.



Upcoming Agenda Topics


  • Status of white paper public review


  • Discuss future working group meeting schedule


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