WG6 Tcon7 Meeting minutes 07312012

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Standardization Roadmap Team Tcon # 7 July 31, 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
Jerker Ringstrom, SixSteps AB
Geoff Mann, SAS Institute
John Anderson, Novo Nordisk
Natalia Smeljanski, Merck
Lynda Sands, GlaxoSmithKline X
Debra Oetzman, Covance X
Sarah Obbers, Janssen Research & Development X
Anisa Scott, SAS institute X
Rick Thompson, Janssen Research & Development X

The group welcomed Rick and Anisa.
A brief overview of the group’s intent and work plan were given, and each member provided a brief overview of their background.

Consensus on elements of the Prioritization Sheet (pdf form)

1) The group viewed an in-process draft of the pdf version of the prioritization exercise for eventual posting on the Wiki. Previously, consensus was gained that we need to make the exercise simple to distribute,fill-out, and compile. A pdf version of the list is in the process of being made by Bob and he showed the current (incomplete) version to the group via Abode connect

- The group agreed on three columns (Study Type, Priority Score, and Rationale). Drop-down lists were preferred for the prioritization score, and null fields should be allowed for this column.
Open text was preferred for the rationale column (perhaps with an “i.e. use in submission” as an example in top of rationale column
-Sheet will have color-coding so that study types that are standardized will be in blue, and study types that are currently being standardized will be red. All other study types will be black font. This is intended to convey prior and current standardization efforts to those who are filling out the sheet.

-Discussion was to post the PDF on the Wiki, and provide info so that people could request the list via email (presumably the same format as is posted on Wiki for ease of compiling final data) al data.)

Discussion about Prioritization Introduction text

Debra contributed the draft Intro, which was loaded onto the Wiki for comments and edits by the group.

-Intro will be tweaked to describe the pdf document (including null, color-coding, etc.) including the points of consensus that were reached in this meeting (above).

-Consensus that the sheet should have an open field at the bottom of the sheet, intended to accept all comments about the roadmap and elements of data utility.

- If the pdf version of the prioritization sheet doesn’t work for some reason, the group discussed that Survey Monkey may be an alternative to explore.

A.I. Bob will finish working-up the first draft of the pdf sheet and distribute it to the group before the next meeting.

A.I. All members should view the Intro (Discussion Tab of Wiki) and edit for the final product.

Last revision by Dorsamr,08/16/2012