Data Standards Monthly Project Lead 28 August 2017 Meeting Minutes

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2017-08-28

Agenda


  • Updates from project leads
  • Annual PhUSE Conference


Attendees

  • Jane Lozano
  • Joyce Leflar
  • Lex Jansen
  • Sandy VanPelt

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 and focus on Define-XML and reviewer's guide. The team should have a solid first draft in about a month. The goal is to have it ready for CSS Steering Committee review by the end of the year. Sandy will work with Marcellina on any overlaps.
Data Reviewer's Guide in XML Mike The team will meet again in September to review the next prototype draft 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 Changed project name to include 'Clinical' to specify this is for clinical legacy data and doesn't include nonclinical legacy data. Team is working with FDA on how to right-size the traceability in the document when a CSR was already created and legacy data is converted to SDTM.
Pooling WHO Drug B3 Format (Best Practices for Integrated Databases) Joyce and Marlo Joyce and Marlo meeting on Wednesday (August 30) to discuss the kickoff. Shannon Labout from CDISC will join this project team.
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 Cleaning up the documents based on nonclinical and CBER comments. Awaiting final comments from FDA.
Pooling WHO Drug B3 Format (Best Practices for Integrated Databases) Joyce and Marlo Joyce and Marlo meeting on Wednesday (August 30) to discuss the kickoff. Shannon Labout from CDISC will join this project team.


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

  • [Mat/Bhavin] Update the flow diagram and put it on the Wiki.
  • [Wendy] Add Prafulla Girase to the meeting invites.