SDSP 21 August 2014 Meeting Minutes

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  • MaryBeth Blauwet
  • Michael Brennan
  • Tony Chang
  • Laura Kaufman
  • Kristin Kelly
  • Susan Kenney
  • Steve Kirby
  • Jane Lozano
  • Nick Naro
  • Anne Russotto
  • Linda Simonsson
  • Peggy Zorn

Meeting Discussion

  • Subgroup assignment was confirmed. There is going to be a new section for the management and versioning of the plan.
  • It is important to have non-clinical addressed in all applicable sections of the plan. However, from a non-clinical perspective, there isn't a list of studies. The non-clinical studies are not handled in the same standard as clinical. It is parsed out in different places. Pooled analysis is not related to non-clinical and therefore representation will not be necessary for this section.
  • The team agreed that the plan is a living document. The team needs to work with the FDA to determine when this plan is presented to the FDA (IND, EOP2, Type C, etc.).
  • The meeting with the steering committee has not occurred.
  • Everyone will be informed when subgroup meetings will occur in case a team member that is not in the subgroup would like to join.
  • Michael discussed the Study Data Standardization Plan that is referenced on the CBER (not CDER) website. The CBER plan doesn't address non-clinical and has aspects of the SDRG and ADRG.
  • Drafts of the document will not be posted to the Wiki. Anne is addressing this with the steering committee. Michael indicated that J&J has an externally facing collaboration site that could possibly be used.

Post Meeting Discussion

  • Jane had a conversation with a colleague that is interested in this project. He suggested that the study start date be included in the list of studies because of the Data Standards Catalog which shows the start and stop dates when a standard is supported. It is important to show when the study starts (could be protocol approval date or first patient visit) to help in determining which version of the standard will be applied.

Action Items

  • [Michael and Jane] Create a project plan and share with the group.
  • [Michael] Investigate if the J&J collaboration site can be used for this project.
  • [Team] Review the CBER plan prior to the next meeting.
  • [Michael and Jane] Schedule subgroup meetings.