Data Standards Monthly Project Lead 25 September 2017 Meeting Minutes

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  • Updates from project leads
  • Annual PhUSE Conference


  • Bhavin Busa
  • Jane Lozano
  • Joyce Leflar
  • Lauren White
  • Lex Jansen
  • Lisa Brooks
  • Marcelina Hungria
  • Prafulla Girase
  • Sandy VanPelt
  • Wendy Dobson

Meeting Discussion

Lisa Brooks will be attending the PhUSE Annual Conference next month in Edinburgh, Scotland. She will be giving a presentation on the projects in this working group and also leading a session (CSS Discussion Club) on the SDTM ADaM Implementation FAQ project. The slides will be updated during this meeting.

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd The team is continuing to work on Disposition (end of treatment, end of study). Todd is going to attend the CDISC Intrachange in November and there will be a session on this project.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy Team continuing on white paper which will focus on Define-XML and reviewer's guide. The goal is to have it ready for CSS Steering Committee review by the end of the year. Sandy will work with Marcelina on any overlaps.
Data Reviewer's Guide in XML Mike The team has developed 3 prototype Data Reviewer's Guides in XML. There is ongoing review. The team has also has created a preliminary stylesheet and a concept map of the cSDRG.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Completion Guidelines Marcellina and Prafulla 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. They are discussing recommendations for challenging items in the Completion Guidleines.
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. 95% done. The team is planning to have an internal review of the Stylesheet before the public review. Planning on submitting to the CSS Steering Committee in September.
Clinical Legacy Data Conversion Plan & Report Jane The team is continuing to work on the first example document (legacy data conversion to SDTM only). There is enough content to begin working on the completion guidelines.
Pooling WHO Drug B3 Format (Best Practices for Integrated Databases) Joyce and Marlo Kick-off meeting was held September 20th. The team will meet once a month for the remainder of the year with the intention of having a draft white paper for review prior to the CSS in March 2018.
SDTM ADaM Implementation FAQ Mat and Bhavin There will be a discussion club session at the PhUSE Annual Conference in October. Lisa Brooks will lead this session. Questions can be submitted via a link on the project’s Wiki website which will take the requestor to a form on the PhUSE website The question will go to Wendy who will collate the questions and will notify Mat/Bhavin. The flow diagram has been updated and is on the project team Wiki site.
Standardizing Data within the Inspection Site Selection Process Parag No new update.
Study Data Standardization Plan (SDSP) Jane Final updates from FDA were sent to Jane. She is reviewing and will work with the team to review the feedback. All documents will be updated by October 6th and sent to FDA.

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.

Action Items

  • [Sandy/Marcelina/Lex] Review the slides Jane created and send updates to Jane by September 27th.