Data Standards Monthly Project Lead 22 June 2020 Meeting Minutes

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  • Project team updates


  • Amy Palmer
  • Bess LeRoy
  • Jane Lozano
  • Janet Low
  • Kiran Kundarap
  • Satheesh Avvaru
  • Vincent Guo
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Mary Nilsson and Aimee Basile White paper has been sent to Jane and Janet for first review.
CDISC Implementation Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy Anticipating an end of summer wrap-up on the deliverables. There is a CDISC webinar on June 30th that will discuss this project.

Bess agreed to 30 minutes at the CSS in September to share the deliverables.

Data Reviewer's Guide in XML Mike Hamidi No new updates.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin The white paper has been sent to Jane and Janet for first review.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo The Industry Experiences white paper has been revised and sent back to Jane and Janet.

They will review it one more time before it is sent to the Steering Committee. The FDA/PMDA white paper will be sent back to Jane and Janet by July 13th with revisions from the first review.

Clinical Integrated Study Data and Analysis Data Reviewers Guide Kiran Kundarapu and Satheesh Avvaru Presenting at the FDA Quarterly meeting on June 24th. The iADRG template is father along than the icSDRG template. Need volunteers to start on example documents for iADRG. Timelines have been revised for a end of year delivery.
SDTM ADaM Implementation FAQ Bhavin Busa, Amy Palmer, and Aatiya Zaidi Comments received from Steering Committee and public review of the ISS/ISE white paper. Presenting at CDISC webinar on June 30th about the project.

  • CSS registration is open and call for posters ends on June 30th. The poster session will be live. Three slides maximum per presenter. Technology ON24 will be used.
  • PHUSE migrated to Teams last weekend. Going to migrate documents from Teamworks to Teams.
  • For the CSS Sessions, project leads should have a detailed scope of the break-out session(s), including plans for how the session will be run and what the project leads hope to achieve.
  • Wendy would like us to put on our thinking caps on ways of being interactive during the CSS.

Action Items

  • [Jane and Janet] Finalize break out sessions for the virtual CSS in September.