Data Standards Monthly Project Lead 24 August 2020 Meeting Minutes

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  • Project team updates


  • Bess LeRoy
  • Jane Lozano
  • Janet Low
  • Kiran Kundarap
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
CDISC Implementation Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy Bess will present at the CSS to give a 20 minute overview of the three deliverables that consist of the primer. There will be 10 minutes for questions.
Clinical Integrated Study Data and Analysis Data Reviewers Guides Kiran Kundarapu and Satheesh Avvaru Volunteers have been identified for three iADRG example documents. Continuing to work on the icSDRG template.
Data Reviewer's Guide in XML Mike Hamidi No new updates. There is a new FDA contact, Jose, who is replacing Isaac. Wendy and Lauren are updating the project tracker in order to share with FDA and begin the conversation of where their participation is requested.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin The white paper is in public review until September 1st.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo The Industry Experiences white paper is in the process of updates from the steering committee, public review, and CDISC. The FDA/PMDA white paper is out for public review until September 21st, but will need to be republished due to changes from additional 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.

  • PHUSE is moving from Teamwords to MS Teams and from the Wiki to Confluence. There will be discussions amongst the working group leads and Wendy/Lauren to determine what to migrate. There will be a separate teams site for each working group and projects within the working group.
  • Wendy would like us to put on our thinking caps on ways of being interactive during the CSS.

Action Items

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