Data Standards Monthly Project Lead 20 May 2019 Meeting Minutes

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  • Project team updates


  • Amy Palmer
  • Jane Lozano
  • Kiran Kundarapu
  • Matilde Kam

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin Project is on hold until June. Mary Nilsson (Standard Analyses and Code Sharing working group) will lead a discussion with this work group at CSS.
CDISC Implementation Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy No new updates.
Clinical Legacy Data Conversion Plan & Report Lisa Brooks and Jane Lozano FDA has provided feedback on the updated ADRG template and completion guidelines based on their initial feedback. Jane will update and send back to Matilde for final review.
Data Reviewer's Guide in XML Mike Hamidi The team is refining the requirements from the initial public release prototype (based on vendor feedback and sponsor example development). Two sponsors DRG-XML examples are being completed in preparation for the FDA pilot, which is dependent on the TBD FR Notice.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin No new updates.
Define-XML v2.0 Completion Guidelines Marcelina Hungria and Prafulla Girase The team is in the final stages of updating the document. The plan is to deliver a clean document by the end of this week.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo Draft white paper should be available prior to CSS.
SDTM ADaM Implementation FAQ Bhavin Busa, Amy Palmer, and Kiran Kundarapu Ongoing project. White paper on adjudication was reviewed by Lisa and Jane. There are comments from the steering committee. Continuing to work on white paper regarding ISS/ISE. Goal is to have a good final draft of both before CSS.

CSS next month! If you are going to be there on Sunday night, Lisa would appreciate your assistance with the booth. Jane will be coming in later Sunday night and won't be able to attend the session. Break out sessions are scheduled for the following projects:

  • Best Practices for Data Collection Instructions (discussion led by Mary Nilsson)
  • CDISC Implementation Primer
  • Industry Experiences
  • SDTM ADaM Implementation FAQ
  • Discussion around the creation of new templates for a cSDRG for integrated SDTM and an ADRG for integrated ADaM

Action Items

  • [Jane]