Data Standards Monthly Project Lead 30 January 2017 Meeting Minutes

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2017-01-30

Agenda


  • Updates from project leads
  • Discuss PhUSE Conference Sessions


Attendees

  • Bhavin Busa
  • Sandy VanPelt
  • Mike Hamidi
  • Marcelina Hungria
  • Dmitry Kolosov
  • Lex Jansen
  • Mat Bryant
  • Jane Lozano
  • Parag Shiralkar
  • Todd Bazin

Meeting Discussion

Working Group Lead Minutes
Best Practices for Metadata Documentation (define.xml versus reviewer's guide) Sandy There will be poster at CSS introducing the white paper. The project team doesn't need a dedicated session, but they will informally meet if needed.
Data Reviewer's Guide in XML Mike Project team is meeting. It is important that there is consistency in the structure of the documents (reviewer's guides, SDSP, legacy data conversion plan & report) when creating them in xml. Sections should not be removed in order to ensure the consistency.
Define v2.0 Implementation & Style Sheet Recommendations - Define-XML 2.0 Implementation (Completion Guidelines) Marcellina Nalin is unable to continue with this project. The goal is to have something ready for review in March at the CSS. No issues with FDA representation.
Define v2.0 Implementation & Style Sheet Recommendations - Define-XML 2.0 Stylesheet Recomendation) Dmitry and Lex Recruited more members after the November 2016 webinar. The goal is to have a draft stylesheet for review in March at the CSS. There is a gap with FDA representation. FDA needs to know specific activities or tasks required.
Legacy Data Conversion Plan & Report Jane Team is creating a decision tree to aid in determining when this document should be created. Team is meeting this week and the plan is to finalize the decision tree so that they can go back to the template.
SDTM ADaM Implementation FAQ Mat and Bhavin Team has 51 participants. There are 5 sub-groups and a lead has been identified for each sub-group. Establishing the framework which is similar to the SEND FAQ process. There is a gap with FDA representation. FDA needs to know specific activities or tasks required.
Standardizing Data within the Inspection Site Selection Process Parag A project is underway at CDISC and a project lead has been identified (Nate Freimark).
Study Data Standardization Plan (SDSP) Jane The project team is meeting tomorrow to discuss comments team members have received on the deliverables. FDA will share their comments in March at the CSS.
Data Collection Instructions Todd This is a new project that will require collaboration with CDISC. A gap analysis will be done on the CDASH completion instructions, focusing on certain domains (AEs, Concomitant Medications, Pregnancy, Reasons for Treatment and Study Discontinuation) to identify potential improvements. This will enable sponsors to fully leverage the recommendations and code from the PhUSE Standard Analyses and Code Sharing Working Group. The project request is being revised to produce a document with suggestions for CDISC to review and implement similar to the Inspection Site Selection Process.

Action Items

  • [Bhavin/Mat] Provide Jane with specific tasks that are required by FDA representation.
  • [Dmitry/Lex] Provide Jane with specific tasks that are required by FDA representation.