Data Standards Monthly Project Lead 29 October 2018 Meeting Minutes

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  • Project team updates


  • Lisa Brooks
  • Wendy Dobson
  • Dmitry Kolosov
  • Marcelina Hungria
  • Prafulla Girase
  • Bess Leroy
  • Nate Freimark
  • Todd Bazin

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. Will work with Wendy to schedule the next few meeting sessions. Scope and collaboration has been decided and they are looking forward to moving forward with the first white paper on stating the current state of industry right now.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy VanPelt Nguyen The team has been addressing the comments from the steering committee. Those will be out to Lisa and Jane later today or tomorrow so that we can get the updates finalized.
CDISC Primer Bearte Hientzsch, Yvonne Moore and Bess Leroy Team met last Thursday and went through the slides from previous meetings. The team has kicked off a new start and will plan meetings after the EU Connect. We have a draft initial scope and the plan is to finalize by the CSS meeting in June.
Clinical Legacy Data Conversion Plan & Report Lisa Brooks and Jane Lozano cSDRG deliverables are out for Public review. No feedback from public review but we would like to make some updates. 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 There were a few public review comments. The team is currently making updates and assessing timelines. Will have more updates by mid-Nov. FDA is interested in doing a pilot.
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin Name will change to Data Standards for Non-Interventional Studies. CDISC is also interested in the non-interventional studies and planning to run a similar project but instead of ADaM they will cover end-to-end standards. There are 3 members from CDISC on the project. In Oct, Jon Neville (from CDISC) presented his slides about the cooperation between CDISC and PhUSE working group. Survey results have been received and reviewed.

Next team meeting is scheduled for the November, 1st. Ron Stewart will present on this meeting about OMOP and about cases that don't fit into ADaM.

Define-XML v2.0 Completion Guidelines Marcelina Hungria and Prafulla Girase The guidelines have been cleaned up and went to Lisa for final ODS review. PhUSE has posted to Steering Committee for final review.
Define-XML v2.0 Stylesheet Recomendation) Dmitry Kolosov and Lex Jansen They discussed the public review comments. There are not too many changes needed following the comments, but still some work is required. Lex is implementing or replying with a response to feedback. The feedback was very good and liked the new features. I expect that we should be able to complete the delivery in November.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo Sub-teams are regularly working and have 3 sub-teams continuing to work on their topics. A draft white paper by year end with conclusion by CSS.
SDTM ADaM Implementation FAQ Bhavin Bhusa, Amy Palmer, and Kiran Kundarapu Ongoing project. No updates. An all team meeting is tomorrow. Two sub teams are working on white papers. A request has gone to FDA for support. We have been receiving new questions and working on responses.

  • Next Webinar is Wednesday, 28 November at 10 am EST.
  • Yuliia and Vladlen will be in Frankfort for the EU Connect. They will have a poster for their project. Lisa will be there as well and is presenting a paper on lessons learned from two submissions. Prafulla will also attend and present on the sample submission topic.
  • US Connect is in February 2019 (Baltimore, MD). Lisa will be attending.
  • CSS is in June 2019 (Silver Spring, MD). Lisa, Jane, Bess, Marcelina, and Nate will be attending.

Action Items

  • [Wendy] Follow-up with Chris regarding where deliverables should reside until they are ready for public review. (update 10/29 Chris, Anup & Wendy will discuss in Frankfurt).
  • [Bess] Follow-up with Nicole and Diane regarding the CDISC Primer project. (update 10/29 Bess is taking over Nicole and Diane as lead. Diane will continue with traceability group. Bess will also pull in additional CDISC group.)
  • [Todd] Provide Wendy with an update in timeline for first white paper deliverable.
  • [Lisa] Check with team leads on finalizing deliverables to determine next steps.
  • [Lisa and Jane] As we come to year end, a review of timelines will be beneficial. Lisa and Jane to facilitate.