Data Standards Monthly Project Lead 24 September 2018 Meeting Minutes

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  • Project team updates


  • Jane Lozano
  • Lisa Brooks
  • Sandy VanPelt Nguyen
  • Tracy Bamford (Wendy out of the office)
  • Vincent Guo
  • Vladlen Ivanushkin
  • Yuliia Bahatska

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin Team working on adverse events with the Standard Analysis and Code Sharing working group.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy VanPelt Nguyen Steering committee has done an initial review. Jane to follow up with Wendy regarding the PhUSE site.
CDISC Primer Scott Bahlavooni and Jasmine Kestermont No updates.
Clinical Legacy Data Conversion Plan & Report Lisa Brooks and Jane Lozano cSDRG deliverables are out for Public review. Feedback is due 12 October. ADRG is in progress.
Data Reviewer's Guide in XML Mike Hamidi Deliverables are on the PhUSE site for public review. Feedback due 28 September. FDA is interested in doing a pilot.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin Name will change to Data Standards for Non-Interventional Studies. Project team had a kick-off meeting. Using a survey to collect feedback from programmers. Jon Neville from CDISC is part of the project team.
Define-XML v2.0 Completion Guidelines Marcellina Hungary and Prafulla Girase Deliverable has been initially reviewed. Team is working to pare it down and an editorial review is needed. Should be delivered to Jane and Lisa by Tuesday, 2 October. Need to ensure there isn't duplication in the white paper.
Define-XML v2.0 Stylesheet Recomendation) Dmitry Kolosov and Lex Jansen Deliverables are out for public review. Feedback is due 28 September.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo Sub-teams are continuing to work on their topics.
SDTM ADaM Implementation FAQ Bhavin Bhusa, Amy Palmer, and Kiran Kundarapu Ongoing project. No updates.

  • Next Webinar is Wednesday, 26 September at 10 am EST.
  • Yuliia and Vladlen will be in Frankfort for the EU Connect. They will have a poster for their project. Lisa will be there as well and is presenting a paper on lessons learned from two submissions.
  • US Connect is in February 2019 (Baltimore, MD). Lisa will be attending.
  • CSS is in June 2019 (Silver Spring, MD). Lisa and Jane will be attending.

Action Items

  • [Wendy] Follow-up with Chris regarding where deliverables should reside until they are ready for public review.
  • [Bess] Follow-up with Nicole and Diane regarding the CDISC Primer project.