Data Standards Monthly Project Lead 30 April 2018 Meeting Minutes

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  • Project team updates
  • CSS comments


  • Dmitry Kolosov
  • Jane Lozano
  • Lisa Brooks
  • Marcelina Hungary
  • Nate Freimark
  • Peter Van Reusel
  • Sandy VanPelt
  • Scott Bahlavooni
  • Todd Case
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin Team has finished disposition and is now working on adverse events. Todd is looking through a LONG list of AE related questions and looking to define clear data entry recommendations. Todd still looking for a co-lead.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy VanPelt Nguyen Team continuing on white paper which will focus on Define-XML and reviewer's guide. White paper will be available for Steering Committee review in June.
CDISC Primer Scott Bahlavooni and Peter Van Reusel Team starting with visualizations. Final deliverable not yet defined. Team still recruiting members.
Clinical Legacy Data Conversion Plan & Report Jane Lozano cSDRG template and completion guidelines updated for the LDCP and to be in alignment with the TCG. A separate group is working on the ADRG deliverables. The template has been updated and one example document created for the LDCP. Deliverables will be available to the steering committee in August. Lisa is leading the ADRG updates.
Data Reviewer's Guide in XML Mike Hamidi Project team is focusing on finalizing the remainder of the XML/Schema content for the DRG in XML. Technical findings with Schema and Stylesheet. Team should have deliverables in June for steering committee review.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Completion Guidelines Marcellina Hungary and Prafulla Girase Timeline updated to provide deliverable to Jane and Lisa in August. Team members include representatives from CDISC Development Team. However, a broader CDISC review will occur after the Steering Committee has reviewed the document.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Stylesheet Recomendation) Dmitry Kolosov and Lex Jansen Deliverables have been sent to Lisa and Jane.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo Jane to follow-up with Todd and Vincent regarding meeting minutes. They want to avoid duplication with the SDTM ADaM Implementation FAQ project. Both teams will meet to clarify roles and expectations.
Pooling WHO Drug B3 Format (Best Practices for Integrated Databases) Joyce Leflar and Marlo Searcy White paper has been reviewed by the Steering Committee. Wendy will send out for public review and work with Crystal for external FDA review.
SDTM ADaM Implementation FAQ Bhavin Bhusa, Peter Van Reusel, and Kiran Kundarapu Ongoing project.

US CSS for 2019 will be in June in Silver Spring. US Connect will be in March 2019. There will be no working group sessions at the 2018 US Connect conference. Scott Bahlavooni and Chris Price are creating a poster about the working groups. Lisa and Chris (Hurley) are creating a poster to show the path of a lab result from collection of the lab to submission.

Action Items

  • [Jane] Follow-up with Todd Case and Vincent Guo regarding their project and posting meeting minutes on the Wiki.