Data Standards Monthly Project Lead 20 May 2019 Meeting Minutes

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  • Project team updates


  • Amy Palmer
  • Jane Lozano
  • Kiran Kundarapu
  • Matilde

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin Project is on hold until June. Mary Nilsson (Standard Analyses and Code Sharing working group) will lead a discussion with this work group at CSS.
CDISC Implementation Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy Plan to share a draft of project deliverable at the CSS. Team approved for a poster for CSS. CDISC will have their meeting Wednesday-Friday the same week of CSS. Abstract submitted for EU Connect (to have a presentation or poster).
Clinical Legacy Data Conversion Plan & Report Lisa Brooks and Jane Lozano FDA has provided feedback on the updated ADRG template and completion guidelines based on their initial feedback.
Data Reviewer's Guide in XML Mike Hamidi Mike and Jane met with FDA (David Epstein and Isaac Chang) to discuss the pilot as Crystal Allard accepted a new position within FDA and is no longer working with PhUSE. The timeline is as follows:
  • By May 31st, finalize DRG-XML package and supporting sponsor sample cSDRGs into XML format.
  • By June 1st, obtain any initial schema feedback from FDA.
  • By June 28th, upload updated DRG-XML package to PhUSE website. Stakeholders to utilize this package as basis for FR notice submission.
  • By July, submit an FR notice.
  • By Dec. 2019/Jan. 2020, FR period closes and all submissions received.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin Project team requested that the survey be extended. Wendy will extend it until the end of May. Team continues to work on white paper and meeting on a monthly basis. Team has a couple of new members.
Define-XML v2.0 Completion Guidelines Marcelina Hungria and Prafulla Girase The team is working through final feedback (around 50% done).
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo Team is meeting regularly and started to collate individual sub-teams information into the template. Deliverable is a white paper. Draft should be available prior to CSS.
SDTM ADaM Implementation FAQ Bhavin Busa, Amy Palmer, and Kiran Kundarapu Ongoing project. White paper on adjudication - comments from steering committee. Continuing to work on white paper regarding ISS/ISE. Goal is to have a good final draft of both before CSS. Project team will have a breakout session at CSS in June.

CSS next month! If you are going to be there on Sunday night, Lisa would appreciate your assistance with the booth. Jane will be coming in later Sunday night and won't be able to attend the session. Break out sessions are scheduled for the following projects:

  • Best Practices for Data Collection Instructions (discussion led by Mary Nilsson)
  • CDISC Implementation Primer
  • Industry Experiences
  • SDTM ADaM Implementation FAQ
  • Discussion around the creation of new templates for a cSDRG for integrated SDTM and an ADRG for integrated ADaM

Action Items

  • [Jane]