Data Standards Monthly Project Lead 26 March 2018 Meeting Minutes

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  • Project team updates
  • CSS comments


  • Dmitry Kolosov
  • Jane Lozano
  • Lisa Brooks
  • Marcelina Hungary
  • Nate Freimark
  • Peter Van Reusel
  • Sandy VanPelt
  • Scott Bahlavooni
  • Todd Case
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin Team has finished disposition and is now working on adverse events. Todd is looking through a LONG list of AE related questions and looking to define clear data entry recommendations.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy VanPelt Nguyen Team continuing on white paper which will focus on Define-XML and reviewer's guide. Team looked at the official version of the cSDRG template on the PhUSE Wiki. Some of the suggestions are in the draft version of the template in the LDCP. Decision tree will be included when items don't fit into the Define and the Reviewer's Guide. White paper will be available for Steering Committee review in June.
CDISC Primer Scott Bahlavooni and Peter Van Reusel Scott led a session at the CSS. Project team meeting on 29 March. Thinking about sending a survey to those outside of industry.
Clinical Legacy Data Conversion Plan & Report Jane Lozano Jane led a session at the CSS. A subgroup has been formed to work on the ADRG deliverables (template, example documents, completion guidelines). cSDRG completion guidelines has a lead. Jane to put together a timeline.
Data Reviewer's Guide in XML Mike Hamidi Project team is focusing on finalizing the remainder of the XML/Schema content for the DRG in XML. Additionally, a supporting paper is undergoing development to accommodate this package. Team should have deliverables in April for steering committee review.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Completion Guidelines Marcellina Hungary and Prafulla Girase Marcellina led a session at the CSS. Team is revising the timeline. Additional interest at CSS for project team members. Team is meeting every other week and planning on meeting once a week in May. Lisa has information that she would like to share. Meeting minutes are in Teamworks. Wendy will check if Lisa and I have access.
Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Stylesheet Recomendation) Dmitry Kolosov and Lex Jansen Team plans on having a stylesheet ready for steering committee review in Q2. Deliverables are the Stylesheet, documentation, and survey. The Stylesheet has been frozen. Team is working on the documentation. Survey is done. The team would like to send it out for external review to CDISC review before FDA. Team should consider the time impact. PMDA has not been involved so far. It should be sent to PMDA when external reviews occur.
GDPR Impact on Collection Practices Sara Pauwels This project is going to be moved to the Data Transparency working group.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case Scott led a session at the CSS. There was a lot of interest and the project team is well established. New co-lead is Vincent Guo. Team starting to meet. They want to avoid duplication with the SDTM ADaM Implementation FAQ project. Both teams will meet to clarify roles and expectations.
Pooling WHO Drug B3 Format (Best Practices for Integrated Databases) Joyce Leflar and Marlo Searcy Team continues to work on an initial draft of the white paper which should be available to Lisa and Jane in April. Plan to be on agenda for Steering Committee review 20 April.
SDTM ADaM Implementation FAQ Bhavin Bhusa, Peter Van Reusel, and Kiran Kundarapu Bhavin led a session at the CSS. New co-leads are Peter Van Reusel and Kiran Kundarapueam. Questions and topics of the breakout sessions included:
    • Integration (ISS and ISE) – integrated SDTM vs. integrated ADaM
    • Adjudication data: where does that go? SDTM or ADaM?
    • Submission of Analysis Results Metadata (ARM)
    • FDA Business/Validation Rules & CDISC Conformance Rules
    • Can the team publish questions received by eData team to PhUSE Wiki?
    • Next version of IG – received feedback/recommendation from the team to pass it on to CDISC
    • Discussed Trial level lookup concept and methods – will pass on discussion summary to CDISC team
Study Data Standardization Plan (SDSP) Jane Lozano The deliverables have been published. The CBER Vaccine example document has been updated and will be published on the PhUSE site (as opposed to the Wiki).

US CSS for 2019 will be in June in Silver Spring. There will be no working group sessions at the 2018 US Connect conference. Scott Bahlavooni and Chris Price are creating a poster about the working groups.

There was discussion at the 2018 CSS regarding the maintenance of the reviewer's guides (cSDRG, nSDRG, ADRG) and the SDSP (i.e. any deliverable that is referenced in FDA guidance). There was a workshop on Monday night focusing on the cSDRG and nSDRG. Wendy has the notes along with a flowchart that was created in a session that Lisa and Jane led within this working group.

Action Items

  • [Jane and Lisa] Create a Radar/Timeline of all projects for tracking purposes.