Data Standards Monthly Project Lead 27 July 2020 Meeting Minutes

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  • Project team updates


  • 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 reviewed by Jane and Janet and feedback provided. Project has moved over to the Safety Analytics working group.
CDISC Implementation Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy There was a CDISC webinar on June 30th.

Janet was able to see the first 45 minutes and then for the question and answer period. Team trying to wrap things up since there are three aspects to the primer. One is a recorded presentation (script finalized and passed to voice). CDISC and PHUSE will present at the CSS. Would like to have all deliverables finalized by CSS.

Data Reviewer's Guide in XML Mike Hamidi No new updates. There is a new FDA contact, Jose, who is replacing Isaac.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin The white paper has been sent to the steering committee for review and will go out for public review August 4th.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo The Industry Experiences white paper is in the public review period until August 13th. Team received feedback from the steering committee. When have feedback from public review will incorporate the steering committee feedback. Estimated publishing date in September. Webinar after publishing to promote the white paper. The FDA/PMDA white paper has been sent back to Jane and Janet to review. Jane completed the review with minor changes and is ready to go to the steering committee.
Clinical Integrated Study Data and Analysis Data Reviewers Guide Kiran Kundarapu and Satheesh Avvaru Continuing to work on the icSDRG template. Need volunteers to start on example documents for iADRG. Kiran will send out another email.

Plan to finish up the icSDRG template at the next meeting so that team members can work on the example documents. Sandy Van Pelt can work on the iADRG Completion Guidelines.

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. Aatiya will review comments by the end of July, time permitting. Team continues to address comments and publish answers.

  • CSS registration is open. Please register by Friday to get early bird.
  • PHUSE migrated to Microsoft Teams for meetings only. They are in the planning stages for using Teams as a repository. The Teamworks subscription expires in November of this year. PHUSE is also in the process of moving away from the Wiki in order to utilize Teamworks which will then be replaced with Microsoft 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 will be putting a Doodle together to do a dry run for CSS.
  • Wendy would like us to put on our thinking caps on ways of being interactive during the CSS.

Action Items

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