Data Standards Monthly Project Lead 31 July 2017 Meeting Minutes

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  • Updates from project leads
  • Annual CSS


  • Dmitry Kolosov
  • Jane Lozano
  • Marcelina Hungria
  • Mat Bryant
  • Sandy VanPelt
  • Susan Kenny
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd The team is continuing to work on Disposition.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy Started meeting again. The plan is to build on the poster that was done for the US CSS this past March. Focus on Define-XML and reviewer's guide. The goal is to have it done this year.
Data Reviewer's Guide in XML Mike The team will meet again in September to review the next prototype draft.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Completion Guidelines Marcellina There is a CDISC webinar on September 28 and this team will present along with Dmitry and Lex's team. Continuing to work on the timeline for the Completion Guidelines review. Her team is working closely with Dmitry and Lex. There is a PhUSE Webinar on August 23. Wendy will send a placeholder to the team. Wendy is calling for presenters now.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Stylesheet Recomendation) Dmitry and Lex The team is now in the testing phase for the internal review. The team is planning to have an internal review of the Stylesheet before the public review.
Legacy Data Conversion Plan & Report Jane No new update. Sub-groups are continuing to work on the Example Documents and Completion Guidelines.
SDTM ADaM Implementation FAQ Mat and Bhavin Wendy documented the information from the EU CSS. The sub-groups are consolidating into one project team with the exception of the Data Submissions sub-group. Going to have a bi-weekly meeting - trial run until October. This group will meet to discuss questions that have been submitted. A new Wiki page has been created to publish approved questions/answers. It is navigated from the project team Wiki page. The team continues to work on a technology solution to ask a question as not everyone can access Google docs. Wendy has requested the funding so that a question will be asked on the PhUSE website which will be linked from the PhUSE Wiki. The question will go to Wendy who will collate the questions and will notify Mat/Bhavin. The flow diagram needs to be updated so that it can be shared on the Wiki.
Standardizing Data within the Inspection Site Selection Process Parag No new update.
Study Data Standardization Plan (SDSP) Jane Meeting scheduled with the project team to review nonclinical and CBER changes on August 7.
WHO Drug B3 Format Best Practices for Integrated Databases Joyce and Marlo The name was changed on the Wiki from WHO Drug B3 Format to Pooling WHO Drug B3 Format. Jane communicated with Barrie Nelson from CDISC. He is no longer in the role with CDISC. However, Shannon Labout from CDISC will join this project team.

The annual CSS is coming up in Edinburgh on October 8-11. The Steering Committee would like to have a discussion with each of the working groups similar to what was done in London this year. Is anyone planning on attending?

The date for the US CSS has been finalized and it will be earlier this year. It is scheduled for March 4-6 in Silver Spring.

Wendy has a conflict for the meeting next month. She will cancel her meeting notice as Jane has sent out a new one.

Action Items

  • [Mat/Bhavin] Update the flow diagram and put it on the Wiki.