SDSP 5 February 2015 Meeting Minutes

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2015-02-05

Agenda


  • Review changes to the template
  • Discuss Test Unit Plan and the suggestion to include in the Study Data Standardization Plan
  • Discuss cover letter suggested by DJ


Attendees

  • Cathy Bezek
  • Mary Beth Blauwet
  • Tony Chang
  • Kate Dwyer
  • Gitte Frausing
  • Beate Hientzsch
  • Laura Kaufman
  • Kristin Kelly
  • Jane Lozano
  • Nick Naro
  • Anne Russotto
  • Linda Simonsson
  • Peggy Zorn

Meeting Discussion

  • The team discussed the template that Jane sent to everyone prior to the meeting. The list of clinical and non-clinical studies are separate sections in the plan as different data applies to each type of study. It was suggested to add the Trial Summary domain parm codes to the list of studies. The template has been updated with the changes discussed in the meeting and comments received after the meeting. The template was sent to the team.
  • Linda sent a link to the team regarding a white paper written on a Test Unit Plan, which is suggesting that this plan be an appendix in the SDSP. A couple of Nick's colleagues worked on this plan. Matthew Bryant is leading the Test Unit Plan effort. It was suggested that this is discussed in more detail at the PhUSE conference with the Test Unit Plan team.
  • The team discussed DJ's suggestion to have a cover letter as part of the SDSP. FDA says in the TCG "cover letter accompanying a study data submission should describe the extent to which the latest version of the Standardization Plan was executed". The team agreed that as part of the SDSP template there should be a sample cover letter with basic structure/format/wording around explaining the extent to which a sponsor's SDSP version was executed.
  • The team decided that it would be beneficial to have a separate room at PhUSE to discuss the template, including the Test Unit Plan. This is opposed to meeting in the big room that working groups met in last year. This team will get the template to a point where we are ready for a broader review by PhUSE members. After that a completion guidelines document will be created.

Action Items

  • [Jane] Update the template based on the discussion and suggestions after the discussion. This is completed.
  • [Jane] Contact Matthew Bryant regarding the Test Unit Plan.
  • [Jane] Contact DJ about getting a separate room at PhUSE to discuss the template and Test Unit Plan.
  • [Nick] Send Jane his thoughts on what could be included in a cover letter.