SDSP 14 April 2015 Meeting Minutes

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2015-04-14

Agenda


  • Finalize Sub-Groups & Members
  • Next Steps
  • Section 3 of the plan (please read it on the Wiki if you have time)
  • Section 4 of the plan if time permits (1 new column added)


Attendees

  • Lisa Brooks
  • Tony Chang
  • Kate Dwyer
  • Jiaan Illidge
  • Dave Izard
  • Maggie Lo
  • Jane Lozano
  • Terek Peterson
  • Peggy Zorn


Meeting Discussion

  • No news on non-clinical review of the template. Peggy indicated that the SEND group is focused on the 3.1 release this week of their IG. The core team meeting hasn't occurred yet. Peggy will follow-up.
  • The sub-groups were discussed and the slide with the names will be uploaded to the Wiki. Lisa will lead the Example Document. Anne will lead the Regulatory Communications. There a few people that aren't on the slide. Please let Jane know which sub-group you are interested in. Jane will also add last names to the slide. Email addresses can be found on the Wiki for the SDSP (main page).
  • The team discussed Sections 2 and 3 from a clinical perspective. Section 2 had a column for the REGID which is from clintrial.gov. The team decided to remove this column as it is not needed for this document. Phase I studies don't always have one. The Application and Sequence Number was also removed from Section 3 as there is confusion as to what these numbers are and they can placed at the beginning of the document. There was further discussion after the meeting about this which will be brought into the next meeting.
  • The team aligned on the goal to have a template done by the end of June. The Example Document team and Completion Guidelines can start but would prefer to have a finalized template to avoid rework. The Regulatory Communications team can start working.

Action Items

  • [Jane] Add last name to the sub-groups.
  • [Jane] Put slides on the Wiki.
  • [Linda/Susan/Yvonne/Pam/Micky/Helen/Peng] Let Jane know if you would like to be a part of a sub-group.