WG6 Tcon6 Meeting minutes 08152012

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Standards Roadmap Tcon #8 August 14, 2012

Member Attended? (x=yes)
Gitte Frausing, Novo Nordisk
Bob Dorsam, FDA X
Alain Nanzer, Roche
Deborah Sholtes, FDA
Lou Ann Kramer, Eli Lilly X
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 X

Action Items Wrap-up: Meeting minutes for Tcon 7 posted today. Prioritization Sheet pdf Version 2 circulated. Introduction text under review.

Core T
eam members published a call-for-participation.
Article posted Aug 9th, in DIJ (DIA journal) for the PhUSE group Call-for participation:


Rick indicated that an internal presentation about PhUSE elicited a question about what expertise is desired for Working Group 6 participants. Multiple members offered that people from diverse backgrounds are needed to achieve multiple perspectives. It was noted that a broad overview of potential backgrounds of participants is listed on each team’s Wiki.

1) Discuss the Introduction text for the Prioritization Exercise

- Please look at it and provide edits prior to our call. http://www.phusewiki.org/wiki/index.php?title=Talk:WG6_Nonclinical_- _Standardization_Roadmap

- Is sharing the document via email preferred? Group consensus is “yes”

- Discuss content. We are looking to provide context in the simplest way possible. We want to give respondents some direction, but keep their minds open because we might very well gain from their less-structured feedback.

- Update intro to reflect pdf format, remove mention of column b, c, g, etc.

Meeting discussion: - Many members offered that the content of the draft intro was well conceived.

- The group would like to proofread and edit the Intro in a Word document rather than on Wiki. Tracked Changes and familiarity were cited as reasons to adopt the more traditional editing process. The downside is that emailing the Word document introduces the potential for editing an obsolete version. With version tracking in mind, the group discussed Google Documents as a potential forum to help track versions.

A.I. Rick will look into Google documents as a forum for finalizing the introduction Word document.

A.I. Intro will be developed off-line by the following volunteering members via email and possibly Google documents
-Bob, Lou Ann, Debra, Rick, Anisa, Lynda, Gitte

Meeting discussion: - Intro should reflect the fact that the respondents will be using the pdf form, thus necessitating a removal of current mention of columns b, c, etc.
-Intro should mention idea of scoring only study headings (i.e. Toxicology) vs. Study types (single or repeat dose tox studies). Respondents may lump studies together by scoring headings, but some may score individual study types (splitters). Mention of these two approaches may be addressed in the intro.

- The group discussed whether we want individuals to respond, or rather a single response from an entire company. The feeling was that getting a company’s input would be of value for their potentially broad perspective. Still, all-comers are welcome. Also, advice should be given to a point-person in each company as it is expected that a unified voice requires one person to collate the response. Intro may include approaches to getting a consensus view for a company (i.e. averaging data along with leadership concurrence). -Consensus was gained that our pdf prioritization sheet should indicate whether someone answering as an individual or as a company.

2) The Prioritization Exercise pdf (circulated prior to our call for your comment) - Incorporated color-code, Columns, and Open Comments field. Other suggestions?

-Discussion points:

- General comments that sheet had a decent appearance, though it is still open for adjustment

- Need a “Name of Respondent section” and check box should be incorporated to indicate if response is from individuals vs. companies

- eCTD numbering should be moved to a separate column for ease-of-reading

- Priority scores should be placed in all major headings to accomodate lumpers vs. splitters. Lumping a score or splitting priorities of study types should be addressed in introductory text

- Font bigger in Comment section text field

- Assistance needed for testing of sheet. i.e. Submit Email Button

A.I. Volunteering members (Rick, Debra, Bob, Anisa, Lou Ann, Gitte) will be included in email string for pdf version-testing and validation.
Bob will circulate Version 3 (reflecting all upgrades) for testing and comment

3) Discuss the concept of forming two small off-line groups for getting these two items finalized

- Meeting discussion: this approach was accepted and the volunteers for our two items (intro text and prioritization pdf form) are listed above.

4) Next steps

- Introductory text development:
Volunteer group works offline via email and Google documents. Goal for finishing not discussed (Post meeting note: Consider a goal of two weeks from now)

- Pdf version testing and validation – Bob will circulate version 3 for testing. Volunteergroup provides testing and feedback

-Tcon on August 28th

Last revision by Dorsamr,08/15/2012