Data Standards Monthly Project Lead 25 March 2019 Meeting Minutes

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  • Project team updates


  • Bhavin Busa
  • Jane Lozano
  • Juliia Bahatska
  • Lisa Brooks
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin No new updates. Todd will not be attending CSS. Project is on hold. Team collaborating on adverse events treatment emergence with the Standard Analysis and Code Sharing working group. Mike Hamidi mentioned that the TransCelerate organization may be doing something similar.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy VanPelt Nguyen Sandy making final updates based on feedback.
CDISC Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy Project is regrouping with the plan to have a deliverable published in Q4 2019. They will look to share their draft at the CSS event in June. There are four sub-teams and two of them have leads. CDISC members can assist with the other 2 projects to help move this forward. Team has submitted a poster for CSS.
Clinical Legacy Data Conversion Plan & Report Lisa Brooks and Jane Lozano ADRG deliverables were updated per FDA comments. After that was done, team received more feedback. Jane working through those comments.
Data Reviewer's Guide in XML Mike Hamidi The team is making further updates based on two supplied sponsor examples for FDA pilot. No breakout session needed at CSS.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin Team has created a survey. Wendy will put in proper communication. Draft white paper in TeamWorks. Goal is to have White Paper published February 2020. Team meeting on monthly basis.
Define-XML v2.0 Completion Guidelines Marcelina Hungria and Prafulla Girase The team is working through final feedback.
Define-XML v2.0 Stylesheet Recomendation) Dmitry Kolosov and Lex Jansen The deliverables have been published on the PhUSE site. This project will not continue as originally discussed. Teamwork will remain open to allow for any communications and the team will manage any questions as and when they come in.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo Draft white paper within the next few weeks.

Would like a breakout session at CSS.

SDTM ADaM Implementation FAQ Bhavin Busa, Amy Palmer, and Kiran Kundarapu Ongoing project. Continuing to work on white papers regarding adjudication and ISS/ISE. Goal is to have a good final draft before CSS. Would like to have a breakout session at CSS in June. Team continue to receive and respond to questions posted. Team submitted two posters for CSS on the white papers.

  • CSS in June planning underway.

Action Items

  • [Jane] Continue to follow up with Sandy and Marcelina/Prafulla on progress. Finalize ADRG with new comments received. Also, contact Mary and Todd regarding their project.