Data Standards Monthly Project Lead 28 January 2019 Meeting Minutes
From PHUSE Wiki
- Project team updates
- Amy Palmer
- Jane Lozano
- Lisa Brooks
- Mike Hamidi
- Scott Bahlavooni
- Wendy Dobson
|Best Practices for Data Collection Instructions||Todd Bazin||No new updates. Team collaborating on adverse events treatment emergence with the Standard Analysis and Code Sharing working group. If there is no movement on this project, it may have to be parked temporarily.|
|Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide)||Sandy VanPelt Nguyen||The document should be ready for publishing in February. Review period has ended and Sandy is working with her to make any suggested updates.|
|CDISC Primer||Beate Hientzsch, Yvonne Moore, Bess LeRoy, and Amy Palmer||Project is regrouping with the plan to have a deliverable published in Q4 2019.
There are four sub-teams and two of them have leads.
|Clinical Legacy Data Conversion Plan & Report||Lisa Brooks and Jane Lozano||cSDRG deliverables have been published on the PhUSE site. ADRG is in the public review period.|
|Data Reviewer's Guide in XML||Mike Hamidi||Changes have been implemented from the public review. FDA is going to do a pilot and the deliverables will be published after pilot.|
|Data Standards for Non-Interventional Studies||Yuliia Bahatska and Vladlen Ivanushkin||No new updates. Team is working on data examples. Ron Stewart (Amgen) is scheduled to give a presentation about OMOP and cases that don't fit into ADaM.|
|Define-XML v2.0 Completion Guidelines||Marcelina Hungria and Prafulla Girase||The team requested additional public review to be extended until January 15th.|
|Define-XML v2.0 Stylesheet Recomendation)||Dmitry Kolosov and Lex Jansen||The deliverables have been published on the PhUSE site. This project will not continue as originally discussed.|
|Industry Experiences Submitting Standardised Study Data to Regulatory Authorities||Todd Case and Vincent Guo||No new updates. The three sub-teams are Communication with Health Authorities (including recommendations), Submission Strategies, and Differences Between FDA and PMDA. Team plans to have a draft white paper by year end with conclusion by CSS.|
|SDTM ADaM Implementation FAQ||Bhavin Bhusa, Amy Palmer, and Kiran Kundarapu||Ongoing project. Team working on adjudication and ISS/ISE white papers. The was a new question on data submissions that has been answered.|
- Scott presented to those on the call PhUSE Working Group Leads and Project Leads Roles and Responsibilities, including Steering Committee responsibilities.
- Starting to plan for US CSS in June.
- [Jane] Follow-up with Todd Bazin and request an update in timeline for first white paper deliverable. Include Lisa and Wendy in the email.