Data Standards Monthly Project Lead 30 July 2018 Meeting Minutes

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  • Project team updates


  • Dmitry Kolosov
  • Jane Lozano
  • Lex Jansen
  • Lisa Brooks
  • Mike Hamidi
  • Nate Friemark
  • Wendy Dobson

Meeting Discussion

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 Team continuing on white paper. Suggestions for updating the cSDRG template were provided to Jane and were discussed in a LDCP&R meeting. Feedback was provided to Sandy. Jane to follow up with her.
CDISC Primer Scott Bahlavooni and Jasmine Kestermont The CDISC standards page has been restructured to be more interactive and include visualizations. CDISC and PhUSE to determine how to best collaborate on this project. Presented at the July webinar. Out of scope are any FAQs as they are addressed by the SDTM ADaM Implementation FAQ project team.
Clinical Legacy Data Conversion Plan & Report Jane Lozano cSDRG deliverables have been sent to Wendy for discussion at the 10 August CSS Steering Committee meeting. Deliverables include the cSDRG template, completion guidelines, two new example documents, updated existing example documents, and a summary of the changes made to the template. The ADRG template has been updated and the team is working on updating one of the example documents.
Data Standards for Observational Studies Yuliia Bahatska and Vladlen Ivanushkin New project. Wendy indicated that there is a new project member. Jane sent project start-up slides to Yuliia and Vladlen to assist with updating the Wiki page for this project./Going to present at July webinar.
Data Reviewer's Guide in XML Mike Hamidi Project team is focusing on finalizing the remainder of the XML/Schema content for the DRG in XML. Technical findings with Schema and Stylesheet. Team should have deliverables in June for steering committee review. (No new update from last month)/Finished a majority of the technical aspects of the project. Currently fine-tuning the remaining schema tasks. Also working on draft reference document. Team should have deliverables in July for Lisa and Jane to review.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Completion Guidelines Marcellina Hungary and Prafulla Girase Timeline updated to provide deliverable to Jane and Lisa in August. Team members include representatives from CDISC Development Team. However, a broader CDISC review will occur after the Steering Committee has reviewed the document. (No new update from last month)/Last week of July for deliverables.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Stylesheet Recomendation) Dmitry Kolosov and Lex Jansen Lisa provided comments to Dmitry and Lex. She also asked a few people to look at the stylesheet. After the updates are made, the deliverables will be shared with the steering committee./Lisa's comments (and those from the person that she asked) reviewed by the team. Next team meeting is 3 July. Team needs to tighten loose ends before sending to steering committee. Deliverables will be available for review in July and steering committee agenda on 10 August. The PhUSE process will ensure that all groups can review. The project team can send to other groups with the link to the deliverables on the PhUSE site.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo Jane followed up with Todd and Vincent regarding meeting minutes. They are also in Teamworks. However, not everyone has access to Teamworks./Todd, Wendy, and Vincent met last week. Meeting again on 26 June and then will assign people to work on the white paper. May change name of project - discussion forum live on the Wiki page. Kiran and Bhavin attend these meetings to ensure there is no overlap.
Pooling WHO Drug B3 Format (Best Practices for Integrated Databases) Joyce Leflar and Marlo Searcy White paper review period has ended. Wendy will follow up with Marlo and Joyce to see if they received any comments./Marlo updated the white paper and it has been published on the PhUSE site. Marlo will present at next quarterly FDA meeting in September. Project is now concluded and Wendy will archive the project on the Wiki.
SDTM ADaM Implementation FAQ Bhavin Bhusa, Peter Van Reusel, and Kiran Kundarapu Ongoing project. Team attended internal quarterly FDA meeting. Team working on ISS/ISE white paper project. Created adjudication team. Need FDA support and team putting together more documentation to request their support.

US CSS for 2019 will be in June in Silver Spring. US Connect will be in February 2019 in Baltimore. Registration opens 2 July.

Action Items

  • [Lisa] Follow-up with the people that she asked to look at the Define-XML 2.0 Stylesheet.
  • [Wendy] Follow-up with Marlo and Joyce regarding the review of their white paper prior to publishing as a final deliverable.