Data Standards Monthly Project Lead 28 October 2019 Meeting Minutes

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  • Project team updates


  • Satheesh
  • Yuliia
  • Aimee
  • Bhavin
  • Janet

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin and Aimee Basile Presenting Poster at the US 2020 Connect. Working on production of survey. Look to publish survey by end of November
CDISC Implementation Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy Poster accepted for US 2020 Connect. Working on abstract for EU Connect. Interactive deliverables currently with CDISC to produce. Deliverable pushed out to Q12020
Data Reviewer's Guide in XML Mike Hamidi Updated package with WGL's to review and then confirm it can go to the Steering Committee. Need to understand if the updated package has to go for another public review. Currently working with PHUSE to seek regulatory support.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin Progress is slow due to members contribution. Wendy to reach out to establish if they still wish to be part of the project. New member joined to replace Ron from Amgen.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo White Paper expected end of year. Differences between PMDA/FDA maybe an independent paper too. Will present at the US Connect 2020 on differences between PMDA/FDA. Draft White Paper to be shared with SC by 1st November.
Integrated Study Data and Analysis Data Reviewers Guide Kiran Kundarapu and Satheesh Avvaru Project title has been adapted to avoid any confusion. Working with PHUSE office to seek regulatory support. Team reviewed survey results and agreement was to create on generic template. If becomes to complex will then look to split. Aim to share findings at the CSS 2020 event. Bi-weekly meetings to be set up.
SDTM ADaM Implementation FAQ Bhavin Busa, Amy Palmer, and Aatiya Zaidi WG BOD to liaise with CDISC with regards to the Adjudication White Paper. Requires clarity on content. This will hold up the final publication. ISS/ISE is with team to incorporate comments from Working Group Leads prior to sending onto the Steering Committee. New process now in place for questions received and team continuing to address unanswered questions. Possible collaboration opportunity on the horizon.

  • Janet Low is the new Working Group Lead and will be working with Jane to support the projects. Janet has worked within a number of teams in the industry since 2006. Janet is a statical programmer at Merck focusing on Study Data Standardisation and the Submission aspect.

Action Items

  • [xxxx] .