Data Standards Monthly Project Lead 22 July 2019 Meeting Minutes

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  • Project team updates


  • Jane Lozano
  • Kiran Kundarapu
  • Satheesh Avvaru
  • Wendy Dobson
  • Yuliia Bahatska

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin and Aimee Basile Project has restarted and Aimee has agreed to co-lead. Kick-off meeting is tomorrow (July 23). Going to keep original scope and concentrate on the treatment emergent white paper first.
CDISC Implementation Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy Traceability sub-team created a presentation for public feedback which closed this past Friday. CDISC Compliance sub-team needs a new lead. Primer scheduled for Q4. Team is going through information captured in the breakout session at CSS.
Clinical Legacy Data Conversion Plan & Report Lisa Brooks and Jane Lozano Jane has sent ADRG deliverables to Wendy. Also, the cSDRG Completion Guidelines was updated and has been sent to Wendy.
Data Reviewer's Guide in XML Mike Hamidi Mike and Jane met with FDA (Dave Epstein and Isaac Chang) and Mike presented at the FDA Quarterly Meeting. Expanded the scope by including the SDSP. Dave will determine if there are prerequisites to the pilot. Phase 1 is for FDA to test and review a prototype package from PhUSE. This package to include a cSDRG-XML (w/stylesheet) and mock Define-XML. If mock datasets are also required, then the team will use existing PhUSE sample datasets. Phase 2 (upon completion of phase #1 (w/ any necessary updates)), the DRG-XML team will upload a new package on the PhUSE website. FDA would conduct an FR Notice to obtain sponsor packages for further testing based on the mentioned updated package. Non-clinical (nSDRG) as XML can be developed in parallel at this phase. February/March 2020 for completion of Phase #1 and Phase #2 FR Notice communicated. The updated DRG-XML package will be available on the PhUSE website.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin Contact with Pinnacle 21 and preparing a summary of rules that are not applicable to non-interventional studies. Continuing to work on draft of the white paper.
Define-XML v2.0 Completion Guidelines Marcelina Hungria and Prafulla Girase The document has been published! Marcelina will be presenting in the next webinar.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo Presentation at PhUSE Single Day Event in September. Draft white paper should be available for review in October.
Integrated SDTM and ADaM Reviewers Guide Kiran Kundarapu and Satheesh Avvaru There is a lot of interest in this project. Wendy has created a page in the PhUSE Wiki and Teamworks. Need to schedule a kick-off meeting, tentatively in October. September 25th is the next webinar after the one in July. It would be good to communicate the project. Team will do a survey asking how sponsors, CROs, TPO, etc. integrate data. Advertised via monthly mailings and social media. For a blog entry, send it to Wendy and she will put it there. Eighteen people have signed up for this project.
SDTM ADaM Implementation FAQ Bhavin Busa, Amy Palmer, and Kiran Kundarapu Ongoing project. One more meeting to review the adjudication white paper prior to publishing. ISS/ISE white paper public review in September/October timeframe. Team has received three new questions. Wendy wants to meet with the project co-leads to discuss process improvements.

Register now for EU Connect. Early bird closes this Friday (July 26).

Action Items

  • [Wendy] The next meeting is August 26. However, this is a bank holiday in the UK. Meeting will be rescheduled for August 19.