Data Standards Monthly Project Lead 29 April 2019 Meeting Minutes

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  • Project team updates


  • Bess LeRoy
  • Jane Lozano
  • Matilde Kam
  • Wendy Dobson

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) can take more of a lead after CSS. Team was collaborating on adverse events treatment emergence. Mary to also communicate with our CDISC reps to see if there is someone that can become more involved. Jane to contact Mary about coming to a break out session during CSS to discuss with this working group.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy VanPelt Nguyen White paper has been published. Wendy to archive the Wiki page and update the website.
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 ADRG Template and Complation Guidelines have been updated per FDA and public review feedback. Documents have been sent back to FDA to review before publishing. Once these documents are approved, the example documents will be updated.
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.
SDTM ADaM Implementation FAQ Bhavin Busa, Amy Palmer, and Kiran Kundarapu Ongoing project. White paper on adjudication has been sent to Lisa and Jane to review prior to submitting to the steering committee. Jane reviewed it. Continuing to work on white paper regarding SS/ISE. Goal is to have a good final draft of both before CSS. Project team will have a breakout session at CSS in June. Team approved for two posters for CSS on the white papers. New question has been published.

CSS in June planning underway. Break out sessions are scheduled for the following projects:

  • 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] Contact Mary about coming to a breakout session for this working group to discuss the Data Collection Instructions project.