WG6 Tcon6 Meeting minutes 07024012

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Standardization Roadmap Team Tcon # 6 July 24, 2012, 10 am EST

Member Attended? (x=yes)
Gitte Frausing, Novo Nordisk X
Bob Dorsam, FDA X
Alain Nanzer, Roche
Deborah Sholtes, FDA
Lou Ann Kramer, Eli Lilly X
Jerker Ringstrom, SixSteps AB
Geoff Mann, SAS Institute X
John Anderson, Novo Nordisk
Natalia Smeljanski, Merck
Lynda Sands, GlaxoSmithKline
Debra Oetzman, Covance X
Sarah Obbers, Janssen Research & Development

Action Item re-cap:

  • Tim agreed to provide a conduit for wider distribution of the prioritization exercise.
  • Gitte determined that we can post the prioritization sheet on the Wiki. It appears that the Wiki doesn’t support Excel sheets, so a pdf solution will be tested (see below).

1. Updates on member's efforts to get prioritization from their companies. Discuss approaches, problems, and solutions.

Discussion:' Debra shared that it was time-consuming to provide context to the exercise during a meeting where she was getting feedback. Consensus was reached that an introductory document would be beneficial to properly frame the exercise.

2. Discuss feedback from Core Team Evaluation...
Core team input: Goal can be to get input on the prioritization exercise from a wider audience

  • Tim and Lilliam will help us to access PhUSE working group.
  • CDISC/SEND distribution can be accomplished through Lou Ann and Gitte.
  • Social networking groups can be accessed via Lou Anne.

Core Team input: How we frame the exercise is important... It could affect the feedback. Members of the core team suggested to aim for prioritization of data utility/accessibility
Proposed: form a small group to get a draft intro together. Some concept that might be included:

  • Intro to problem of data inaccessibility
  • Informatics solutions for improved data access
  • Intro to our group, our purpose. (helpful material may be on Wiki)
  • Explain prioritization exercise and its goal
    • Leaving the responders some freedom to identify their own priorities (even outside of current context of data standardziation)

A.I. – Debra volunteered to start a draft of the Intro document. The group agreed to edit and comment on the document on the team’s Wiki page. Debra will circulate an email to let us know when the first draft has been posted on the Wiki.

Gitte indicated that the Excel prioritization sheet may not be a supported format on the Wiki. A pdf form of the sheet will be tested as a workaround, so that everyone who wants to provide feedback can do so by downloading this sheet (in pdf format)

A.I. Bob will try to work up a pdf sheet based from the current Excel sheet.

Core Team Input: Consider providing metrics on the nature of group’s responses. Is there a pattern that could crystallize an effort among a subset of respondents? This comment will be kept in mind as we collect feedback.

Bob mentioned that we should maintain awareness of other teams activities. The Interconnectivity Team data sheet (with many study types) was circulated to the group. Post-meeting note: This may provide some inspiration as we consider the full extent of nonclinical development in the roadmap and e-paper.

Post-meeting A.I. Bob should provide our new member Anisa Scott with onboarding material

Our plan is to formulate the intro for the prioritization sheet over the next week and get detailed input by the end of the next meeting for finalization. The pdf version of the sheet should be worked on in parallel so that both the intro and sheet are ready for distribution by August 3rd (a s a goal).

Our next meeting will be held next Tuesday