Data Standards Monthly Project Lead 27 February 2017 Meeting Minutes

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  • Updates from project leads
  • Discuss PhUSE Conference Sessions


  • Bhavin Busa
  • Jane Lozano
  • Marcelina Hungria
  • Michael Johnson
  • Mike Hamidi
  • Nate Freimark
  • Sandy VanPelt Nguyen
  • Steve Wilson
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
Best Practices for Metadata Documentation (define.xml versus reviewer's guide) Sandy The focus lately has been on the poster at CSS introducing the white paper. If the team wants to meet at CSS, it will be done informally.
Data Reviewer's Guide in XML Mike There is a concept map of the cSDRG - it's in the infancy stage. Josef Aerts has a lot of technical expertise.
Define v2.0 Implementation & Style Sheet Recommendations - Define-XML 2.0 Implementation (Completion Guidelines) Marcellina Marcellina will be looking for a CSS industry volunteer for her project. She will split the time at the CSS with the stylesheet recommendation project. Confirmation from Kate Dwyer (FDA) is needed as she has indicated interest but has been unable to attend meetings. Marcellina will speak with Mike Hamidi about his project offline as there is a connection.
Define v2.0 Implementation & Style Sheet Recommendations - Define-XML 2.0 Stylesheet Recomendation) Dmitry and Lex No new updates. Dmitry and Lex were unable to attend.
Legacy Data Conversion Plan & Report Jane Helena from FDA is our new champion. Welcome Helena! The decision tree is complete and the team is now going to focus on the template again.
SDTM ADaM Implementation FAQ Mat and Bhavin Team working on the structure and the best way to technologically set it up. The nonclinical used a discussion forum which required a moderator (constant involvement). Team determining the best way to collect the questions on the Wiki. Wendy has posed the question to the newly formed Wiki team and requested that someone within this team work on it. There are 2 that specialize on the system side, and they are volunteers. FDA indicated that they cannot dedicate someone to this project at this time. FDA gets questions and this project team would like access to the questions. Access roster review required.
Standardizing Data within the Inspection Site Selection Process Parag Diane at CDISC is now involved. The SDTM part of the suggestions is not difficult to implement. The ADaM part, however, is more difficult. It is possible that part of this could be handled in the controlled terminology.
Study Data Standardization Plan (SDSP) Jane The template has been updated based on the comments received by team members. FDA will share their comments in March at the CSS.
Data Collection Instructions Todd Todd was unable to attend.

Action Items

  • [Jane] Follow up with Kate Dwyer.