Data Standards Monthly Project Lead 28 January 2019 Meeting Minutes

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  • Project team updates


  • Amy Palmer
  • Jane Lozano
  • Lisa Brooks
  • Mike Hamidi
  • Scott Bahlavooni
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin No new updates. Team collaborating on adverse events treatment emergence with the Standard Analysis and Code Sharing working group. If there is no movement on this project, it may have to be parked temporarily. 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 The document should be ready for publishing in February. Review period has ended and Sandy is working with the project team to make any suggested updates.
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.
Clinical Legacy Data Conversion Plan & Report Lisa Brooks and Jane Lozano cSDRG deliverables have been published on the PhUSE site. ADRG is in the public review period.
Data Reviewer's Guide in XML Mike Hamidi Changes have been implemented from the public review. FDA is going to do a pilot and the deliverables will be published after pilot. Will look to do an FR notice with a view to have the paper published in Q419
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin No new updates. 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. Yuliia is transitioning to a new Company and will look to kick start meetings in February
Define-XML v2.0 Completion Guidelines Marcelina Hungria and Prafulla Girase The team requested additional public review to be extended until January 15th. Public review period is now closed and the project is looking to finalise their White Paper
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 No new updates. The three sub-teams are Communication with Health Authorities (including recommendations), Submission Strategies, and Differences Between FDA and PMDA. The project is meeting weekly to collate all content into one White Paper. Will look to share draft by end of February with Working Group Leads. Aim to go through the review process and present at the CSS in June
SDTM ADaM Implementation FAQ Bhavin Bhusa, Amy Palmer, and Kiran Kundarapu Ongoing project. Team working on adjudication and ISS/ISE white papers. White Papers due to be finalised by end of Q1 with a view to having a breakout session at CSS in June. Team continue to receive and respond to questions posted.

  • Scott presented to those on the call PhUSE Working Group Leads and Project Leads Roles and Responsibilities, including Steering Committee responsibilities.
  • Starting to plan for US CSS in June.

Action Items

  • [Jane] Follow-up with Todd Bazin and request an update in timeline for first white paper deliverable. Include Lisa and Wendy in the email.