Data Standards Monthly Project Lead 30 May 2018 Meeting Minutes

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  • Project team updates


  • Jane Lozano
  • Lisa Brooks
  • Nate Friemark
  • Sandy VanPelt
  • Wendy Dobson
  • Yuliia Bahatska

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 looking through a LONG list of AE related questions and looking to define clear data entry recommendations. Todd still looking for a co-lead. (No new update from last month)
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy VanPelt Nguyen Team continuing on white paper. Finishing up on examples and combining content into one paper. Included is what type of metadata and where it should be documented (Define-XML or reviewer's guide) with the objective to eliminate redundancy. There is a section on how to handle outliers along with differences between review agencies. White paper will be available for Steering Committee review in the last half of June.
CDISC Primer Scott Bahlavooni and Peter Van Reusel Team starting with visualizations. Final deliverable not yet defined. Team still recruiting members. (No new update from last month)
Clinical Legacy Data Conversion Plan & Report Jane Lozano cSDRG template and completion guidelines updated for the LDCP and to be in alignment with the TCG. These are to be finalized at the next meeting. All example documents will be updated after the template is finalized. The deliverables may be sent to the steering committee separately as the cSDRG is farther along than the ADRG. The ADRG template has been updated to include the LDCP and to be in alignment with the TCG. Jane contacted the original authors of the ADRG to ask if they would like to be included in this update. Jane also let Crystal (FDA) know why a FDA representative would be needed for input similar to what was done with the cSDRG.
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.
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)
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)
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.
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.
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.
SDTM ADaM Implementation FAQ Bhavin Bhusa, Peter Van Reusel, and Kiran Kundarapu Ongoing project.

US CSS for 2019 will be in June in Silver Spring. US Connect will be in March 2019. There will be no working group sessions at the 2018 US Connect conference. Scott Bahlavooni and Chris Price are creating a poster about the working groups. Lisa and Chris (Hurley) are creating a poster to show the path of a lab result from collection of the lab to submission.

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.

=Meeting Discussion