Data Standards Monthly Project Lead 27 August 2018 Meeting Minutes

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  • Welcome new member to working group
  • Project team updates


  • Bess LeRoy
  • Jane Lozano
  • Jasmine Kestermont
  • Lex Jansen
  • Lisa Brooks
  • Mike Hamidi
  • Sandy VanPelt Nguyen
  • Vincent Guo

Meeting Discussion

Bess LeRoy is our new CDISC liason for this working group. Welcome Bess!

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin Team has finished disposition and is now working on adverse events. Todd is going to collaborate with the Standard Analysis and Code Sharing working group on adverse events. Meetings are scheduled in September and October.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy VanPelt Nguyen Sandy has sent the white paper to Lisa and Jane. Sandy is putting finishing touches (references and examples) in the white paper but Jane and Lisa can begin their review. Jane will send to Wendy for Steering Committee meeting in September. Wendy will put on the PhUSE site for public review.
CDISC Primer Scott Bahlavooni and Jasmine Kestermont Team has recruited more volunteers and is expanding rapidly. A lot of people are interesting in knowing more about the primer but not necessarily have a lot of experience. Nicole Harman (CDISC) will be filling in for Jasmine in the short term. Diane from CDISC as well will be taking a lead. Bess will follow-up with Nicole and Diane. Two components to this project one of which is the link to the CDISC standards page. The second one is more graphical in nature with less emphasis on documentation. Some components will be on the CDISC site and others on the PhUSE site.
Clinical Legacy Data Conversion Plan & Report Lisa Brooks and Jane Lozano cSDRG deliverables are ready for Public review. ADRG is in progress.
Data Reviewer's Guide in XML Mike Hamidi Deliverables are on the PhUSE site for public review.
Data Standards for Observational Studies Yuliia Bahatska and Vladlen Ivanushkin Name will change to Data Standards for Non-Interventional Studies. Bess knows someone from CDISC that is working on this on the CDISC side.
Define-XML v2.0 Completion Guidelines Marcellina Hungary and Prafulla Girase Deliverables should be available in September so that they can be sent to the steering committee in October.
Define-XML v2.0 Stylesheet Recomendation) Dmitry Kolosov and Lex Jansen Deliverables are out for public review.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo The project team has divided into three sub-teams. The first one is strategy and planning. The second one is exploring differences between PMDA and FDA. The third one is communications with regulatory and health authorities around standardized data. Sub-teams are meeting twice a month. Each team will provide a report by end of December. This will be consolidated into one white paper in Q1 2019 with the goal of publishing the white paper before the CSS in June. Project is using Teamworks for each sub-team. Todd and Vincent will ensure the content will not overlap with other ODS projects.
SDTM ADaM Implementation FAQ Bhavin Bhusa, Amy , and Kiran Kundarapu Ongoing project. The steering committee discussed the FDA request for support documents at the last meeting. Bhavin will work with Crystal (FDA) to create a template to share with Lisa and Jane and then back to the steering committee. The template can then be used by other working groups as well.

Wendy will have a discussion with Chris regarding the storage location for deliverables that are not published yet but teams are working on them. Should the Wiki be the place for these documents?

Action Items

  • [Lisa] Follow-up with Wendy regarding how the communications are sent regarding deliverables that are ready for public review.
  • [Lisa] Follow-up with Wendy regarding the cSDRG deliverables.
  • [Lisa and Jane] Review Sandy's white paper and provide feedback by August 31st.
  • [Wendy] Follow-up with Chris regarding where deliverables should reside until they are ready for public review.
  • [Wendy] Change the name of the project 'Data Standards for Observational Studies' to 'Data Standards for Non-Interventional Studies'.
  • [Bess] Follow-up with Nicole and Diane regarding the CDISC Primer project.
  • [Bess] Follow-up with a colleague at CDISC that is working on the Data Standards for Observational Studies project.