Data Standards Monthly Project Lead 28 September 2020 Meeting Minutes

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2020-09-28

Agenda


  • Project team updates


Attendees

  • Jane Lozano
  • Kiran Kundarap
  • Lauren White

Meeting Discussion


Working Group Lead Minutes
CDISC Implementation Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy Bess presented at the CSS. Deliverables will be published on the CDISC site and possibly PHUSE site.
Clinical Integrated Study Data and Analysis Data Reviewers Guides Kiran Kundarapu and Satheesh Avvaru Successful breakout sessions at the CSS. Team received a lot of feedback and is incorporating it into the templates.
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 is now published!
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo The Industry Experiences white paper has been published! The FDA/PMDA white paper public review has ended and team is incorporating feedback.
SDTM ADaM Implementation FAQ Bhavin Busa, Amy Palmer, and Aatiya Zaidi ISS/ISE white paper in the process of being updated from steering committee feedback and public review. Team continues to address comments and publish answers.


Action Items

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