SDSP 19 February 2015 Meeting Minutes

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2015-02-19

Agenda


  • Review updated template (with TS variables added) and discuss last column in the list of studies (Study Data Submitted). There have been email discussions in which it was suggested to change it to ‘Study Data Submitted Electronically’.
  • Discuss cover letter template.


Attendees

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

Meeting Discussion

  • The team reviewed and discussed the latest template with an initial focus on the proposed “Study Data Submitted” column. Scenarios were identified where datasets were not directly included, but referenced. The team recommend a more explicit column header, “Study Datasets Submitted Electronically” with an intent to be populated as a Boolean flag. The group discussed the scope of the plan, specifically previous trials may be referenced but are not considered a submission study. The team recommended the inclusion of the “Application and Sequence #” column to reference previous registrations.
  • OBSERVATION: Wouldn’t the “Application and Sequence #” and “Registry Identifier” in the Clinical Studies table create a population conflict? Can the “registry Identifier” in table 2.2 be removed with the assumption each SDSP would be associated with a registration (populated on the title page as “Unique Submission Identifier”)
  • To address the scope question regarding the inclusion of referenced studies that may have used in a previous submission, the team recommended a updated title to section to specify the cumulative intent of the list of studies.
  • The team discussed the use of the SDSP as a living document and the potential for a study to be dropped from the list of studies. The ‘Revision History’ should be used to document version changes; when available, the revision history should also reference agency meeting minutes that alter the list of studies.
  • The representation of the column ‘tags’ were discussion. The team agreed the intent of the tags should be outlined in a user guide (and possible on the template). The team discussed the benefits of linking existing controlled terminology to each column and agree published terminology should be referenced, but not directly inserted. The team recommends including references both the [Trial Summary Parameter code], as previously agreed, in square brackets and associated (controlled terminology) in parentheses.
  • The team discussed quality concerns that may arise from a self-regulated document. The heading was updated to remind sponsors to confirm their entries. The team also recommends a reminder into the accompanying guidance document.
  • The team discussed possible topics for the March CSS. Some topics included 1) triggers to create and update the SDSP and 2)recommendations for owners of the SDSP.
  • The draft cover letter was discussed. The team agreed to investigate the intent of the cover letter and better understand DJ’s request. Question came up about the intended agency audience for the SDSP – the eDATA team, individual reviewers? The team discussed how the SDSP might be delivered to the agency as part of ongoing meetings, such as the existing, type B, C, or pNDA meetings. There was mention to create cover letter language to include into existing meeting agenda as an addition or alternative to a dedicated cover letter.
  • The team discussed the cross reference with the study data reviewers guide and analysis guide. We also spoke about areas of potential overlap and how we might address it. The reference to the SDRG is also a potential topic for the March’s CSS.
  • Jane sent an email to Matthew Bryant regarding the Test Units Plan. Jane requested a separate room at PhUSE to discuss the SDSP and the Test Units Plan.

Action Items

  • [Jane] Create meeting minutes and send to the team.