Data Standards Monthly Project Lead 22 May 2017 Meeting Minutes

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  • Updates from project leads
  • EU CSS Participation


  • Jane Lozano
  • Mat Bryant
  • Mike Hamidi
  • Susan Kenny
  • Todd Bazin

Meeting Discussion

Working Group Lead Minutes
Best Practices for Metadata Collection Instructions Todd The first project team meeting was held on Friday, May 19. The team established ground rules and aligned on the scope. The team will meet every other Friday. The first domain that team is working on is Disposition. There is CDISC representation.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy No new update.
Data Reviewer's Guide in XML Mike There has been a second update to the cSDRG prototype and that has gone through a round of reviews within the project team. The team is working on a stylesheet. There is FDA representation. The team is anticipating a review by the CSS Steering Committee in July or August.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Completion Guidelines Marcellina No new update.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Stylesheet Recomendation) Dmitry and Lex No new update.
Legacy Data Conversion Plan & Report Jane The sub-group working on the example documents is struggling with the template. It was suggested that if the template doesn't fit it is okay to recommend changes based on the team's experiences in converting legacy data.
SDTM ADaM Implementation FAQ Mat and Bhavin A survey was sent out regarding the sub-groups and if there could be a consolidation of a couple of them. The team is trying to figure out the best way to publish questions/answers that the team has already addressed. In the CSS Steering Committee meeting on May 19, there was a discussion on who needs to review questions/answers prior to publishing them on the PhUSE Wiki. Crystal (FDA) is going to follow-up with Helena. The SEND group has their own Wiki which operates similar to Wikipedia in that the content is updatable. When Wendy returns from medical leave, she will set up some time with Troy Smyrnios who worked with the SEND FAQ team in regards to technology. There are issues with the SEND FAQ that Mat and Bhavin would like to avoid. This project is planned for a break-out session at the EU CSS in June. Jane will follow up with Scott Bahlavooni to ensure someone from the EU will be able to facilitate the session.
Standardizing Data within the Inspection Site Selection Process Parag No new update.
Study Data Standardization Plan (SDSP) Jane No new update.
  • A new project request was created for 'Implementing the WHO Drug B3 Format Best Practices for Integrated Databases'. Two co-leads have been identified and the project request will be on the agenda for the June 2 CSS Steering Committee meeting.

Action Items

  • [Jane] Follow up with Scott Bahlavooni regarding the EU CSS.