Data Standards Monthly Project Lead 24 September 2018 Meeting Minutes
From PHUSE Wiki
- Project team updates
- Jane Lozano
- Lisa Brooks
- Sandy VanPelt Nguyen
- Tracy Bamford (Wendy out of the office)
- Vincent Guo
- Vladlen Ivanushkin
- Yuliia Bahatska
|Best Practices for Data Collection Instructions||Todd Bazin||Team working on adverse events with the Standard Analysis and Code Sharing working group.|
|Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide)||Sandy VanPelt Nguyen||Steering committee has done an initial review. Jane to follow up with Wendy regarding the PhUSE site.|
|CDISC Primer||Scott Bahlavooni and Jasmine Kestermont||No updates.|
|Clinical Legacy Data Conversion Plan & Report||Lisa Brooks and Jane Lozano||cSDRG deliverables are out for Public review. Feedback is due 12 October. ADRG is in progress.|
|Data Reviewer's Guide in XML||Mike Hamidi||Deliverables are on the PhUSE site for public review. Feedback due 28 September. 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. Project team had a kick-off meeting. Using a survey to collect feedback from programmers. Jon Neville from CDISC is part of the project team.|
|Define-XML v2.0 Completion Guidelines||Marcellina Hungary and Prafulla Girase||Deliverable has been initially reviewed. Team is working to pare it down and an editorial review is needed. Should be delivered to Jane and Lisa by Tuesday, 2 October. Need to ensure there isn't duplication in the white paper.|
|Define-XML v2.0 Stylesheet Recomendation)||Dmitry Kolosov and Lex Jansen||Deliverables are out for public review. Feedback is due 28 September.|
|Industry Experiences Submitting Standardised Study Data to Regulatory Authorities||Todd Case and Vincent Guo||Sub-teams are continuing to work on their topics.|
|SDTM ADaM Implementation FAQ||Bhavin Bhusa, Amy Palmer, and Kiran Kundarapu||Ongoing project. No updates.|
- Next Webinar is Wednesday, 26 September 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.
- US Connect is in February 2019 (Baltimore, MD). Lisa will be attending.
- CSS is in June 2019 (Silver Spring, MD). Lisa and Jane will be attending.
- [Wendy] Follow-up with Chris regarding where deliverables should reside until they are ready for public review.
- [Bess] Follow-up with Nicole and Diane regarding the CDISC Primer project.