Data Standards Monthly Project Lead 28 January 2019 Meeting Minutes

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  • Project team updates


  • Bess LeRoy
  • Dmitry Kolosov
  • Jane Lozano
  • Lex Jansen
  • Lisa Brooks
  • Marcelina Hungria
  • Mike Hamidi
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin Team collaborating on adverse events treatment emergence with the Standard Analysis and Code Sharing working group. No new updates. Jane to contact Todd.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy VanPelt Nguyen The document is ready for public review. Wendy to put on PhUSE site.
CDISC Primer Beate Hientzsch, Yvonne Moore and Bess LeRoy Next meeting is 6 December. The team is ensuring the current scope is in alignment with what Peter had planned when this project began.
Clinical Legacy Data Conversion Plan & Report Lisa Brooks and Jane Lozano cSDRG deliverables have been sent to Wendy and will be published this week. Jane will present at the Webinar on Wednesday a summary of the changes. ADRG is in progress with all documents drafted and will go to steering committee soon (final drafts completed for template, example, and completion guidelines).
Data Reviewer's Guide in XML Mike Hamidi Changes have been implemented from the public review. The deliverables will be published after the meeting with FDA to discuss a pilot. Mike is aware of changes to the cSDRG and will need to apply updates to his deliverables.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin Team is working on data examples. Ron Stewart (Amgen) is scheduled to give a presentation about OMOP and cases that don't fit into ADaM.
Define-XML v2.0 Completion Guidelines Marcelina Hungria and Prafulla Girase The team has applied updates based on feedback from the steering committee. It will be sent back this week. Public review will be the month of December and part of January.
Define-XML v2.0 Stylesheet Recomendation) Dmitry Kolosov and Lex Jansen The deliverables have been updated based on public review. They are ready to be published. Dmitry and Lex will create a document to summarize the changes based on public review. Wendy will ask Scott if there is a template that can be used.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo The three sub-teams are Communication with Health Authorities (including recommendations), Submission Strategies, and Differences Between FDA and PMDA. Team plans to have a draft white paper by year end with conclusion by CSS.
SDTM ADaM Implementation FAQ Bhavin Bhusa, Amy Palmer, and Kiran Kundarapu Ongoing project. Team working on adjudication and ISS/ISE white papers. The was a new question on data submissions that has been answered.

  • Starting to plan for US CSS in June.

Action Items

  • [Wendy] Follow-up with Chris regarding where deliverables should reside until they are ready for public review. Most teams use TeamWorks.
  • [Wendy] Ask Scott for an example of a document that summarizes changes to deliverables based on public review.
  • [Todd] Jane to follow up with Todd Bazin and request an update in timeline for first white paper deliverable. Include Wendy in the email
  • [Jane] Send updated project tracking spreadsheet to Scott, Wendy, and Bess. Also put it on the ODS Wiki page.