Data Standards Monthly Project Lead 27 January 2020 Meeting Minutes

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  • Project team updates


  • Aatiya Zaidi
  • Amy Palmer
  • Bess LeRoy
  • Jane Lozano
  • Janet Low
  • Kiran Kundarapu
  • Mike Hamidi
  • Satheesh Avvaru
  • Vincent Guo
  • Wendy Dobson
  • Yuliia Bahatska

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin and Aimee Basile Presenting Poster at the US 2020 Connect. Survey has closed. Mary Nilsson are Aimee are reviewing the results today prior to the next project meeting on February 14th. Goal is to use the results in the white paper.
CDISC Implementation Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy Presenting Poster at the US 2020 Connect. Leads met after the holiday with Wendy to determine how to re-energize the group. Plan to finish in June. Some deliverables are with CDISC (voice over for PowerPoint) and some with PHUSE. Four pieces to the Primer: Traceability (Power Point with voice over), Compliance (stalled at the moment), Getting Started with CDISC (series of 3 minute videos and content link), and Linking Between Models (content on the CDISC website - interactive dynamic diagram). Need to figure out how to show the Primer on the CDISC and PHUSE sites.
Data Reviewer's Guide in XML Mike Hamidi Updated package (second prototype) published on PHUSE website as a final deliverable. Project is on pause for a few months. FDA wants to test this with nSDRG, but project team has not created the nSDRG in XML due to resources. Separate sub-group to work on the SDSP in XML. Not done due to resources. FR Notice for Intent to Review for the nSDRG so that FDA can test it using their tools. Another sub-group to work on the ADRG. Order of priority: Get feedback from technical vendors for cSDRG (none received at the moment). Mike posted this on LinkedIn. Use that for nSDRG and then ADRG. SDSP to be worked on in parallel. Wendy to send communication prior to US 2020 Connect.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin White paper pushed out to Q22020. No update from FDA from the presentation in December 2019. Team can continue to work on the white paper.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo Team creating two separate white papers (main paper and other one focusing on the differences between FDA and PMDA). Plan to send to Jane and Janet within the next two weeks. Presenting paper and poster at the US 2020 Connect.
Clinical Integrated Study Data and Analysis Data Reviewers Guide Kiran Kundarapu and Satheesh Avvaru Template is on Teamworks site for project members to edit and comment. Making progress on the template. Looking for volunteers for take the lead on the Completion Guidelines (Sandy VanPelt) and example documents. Two statisticians joined the team. ADaM integration document created by CDISC is on hold pending further discussions with FDA. No plan to publish as CDISC needs to get consensus from various groups.
SDTM ADaM Implementation FAQ Bhavin Busa, Amy Palmer, and Aatiya Zaidi ISS/ISE white paper sent to Jane and Janet.

There are comments to be addressed prior to sending to the Steering Committee. Team continuing to get questions and publishing responses. Members of ADA (Antidrug Antibody) project (non-clinical) for immunogenicity in SDTM and ADaM want to possibly collaborate with this team. Amy is the SME or someone within CDISC. This is on hold for the moment. Issues with getting people together and ADA white paper is not published yet (in public review period).

  • US Connect next conference. Registration is delayed for the US CSS as PHUSE is working on new system for registration. Any projects that wish to present and do a break-out there needs to be a justification.

Action Items

  • [xxxx] .