SDSP 20 November 2014 Meeting Minutes

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  • Review sub-group progress and discuss next steps.


  • Michael Brennan
  • Tony Chang
  • Beate Hientzsch
  • Jane Lozano
  • Nick Naro
  • Pam Ryley
  • Linda Simonsson

Meeting Discussion

  • Michael reiterated that he would like the plan should be 'smart' in that there are drop-down boxes with a list of values, links between the sections, and the capability to query, sort, and sub-set.
  • Michael and Jane discussed the progress of the sub-groups:
  • 1) List of Clinical and Non-Clinical Studies: Michael has been meeting with the sub-groups. The list will use consistent terminology and will utilize controlled terminology as much as possible. The list should include all studies. He will be meeting with this sub-group within the next week or two.
  • 2) Pooled Analysis: Pam has created tables with metadata about pooled analysis that has the linking and drop-down boxes.
  • 3) Standards & Controlled Terminology: The group has had several meetings and the information is
  • 4) Legacy Data Conversion: Jane has received 2 different responses from 2 FDA representatives in regards to the Legacy Data Conversion Plan that is being developed. The plan could be part of the Study Data Standardization Plan or a separate plan. Michael will discuss with the Steering Committee.
  • By the time of the PhUSE meeting in March of next year, this working group should have a draft template and supporting documents. There should be break-out sessions during the meeting and a presentation to the Steering Committee.
  • Jane started on the creation of a template for this plan and shared it with the group.
  • The group discussed where the plan template should reside - On the FDA data standards site or within PhUSE? Also, the drop down boxes will need to be maintained but how and who will do it needs to be addressed.

Action Items

  • [Jane] Send email to Michael regarding the section of the plan that discusses legacy data conversion. Michael will discuss with the Steering Committee on November 21st if time permits.
  • [Jane] Schedule next group meeting in December.