WG6 Tcon9 Meeting minutes 08292012

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Standards Roadmap Tcon #9 August 28, 2012

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
John Anderson, Novo Nordisk
Natalia Smeljanski, Merck
Lynda Sands, GlaxoSmithKline
Debra Oetzman, Covance X
Sarah Obbers, Janssen Research & Development X
Anisa Scott, SAS Institute X
Rick Thompson X


Pdf Prioritization Document

- Bob showed the current form which reflects all suggestions to-date.

- Upon viewing the form (Version 6), the group accepted the overall appearance of the pdf form. All elements of voting, submission by email,and compilation into a single spreadsheet have been tested and validated.

- Edits were suggested, including: minor edits to directions at top of form, deleting repeated cells at bottom of page 2, update CV and respiratory safety pharm as “under development”

- The group agreed that a 45 day period for returning the form was the most practical deadline for responses.

A.I. Bob will circulate the form with all suggested updates (V 7)

- Viewing the Excel sheet which is the compiled output from all responses

- The spreadsheet with combined data appears acceptable to the group. One comment was on the numeric coding of individual vs. company responses. A more accurate text representation will be accomplished in an updated form.
-Bob mentioned that the survey responses will have to be placed into context of our group’s inclinations about the Roadmap.

Introduction text

- Status: The PhUSE site can facilitate Word document archiving along with Version tracking. To date, there doesn’t appear to be a “check out” feature which would prevent parallel edits.
- With some testing, Rick and Bob gathered a few things about PhUSE Wiki version tracking – A user must be logged in to upload a document, and it seems that they must log out before seeing the changes reflected in the updated version.
-The group decided that the edits to the Introduction Text were not significant enough to warrant such version tracking. Edits will be done via email

A.I. Rick will distribute the Word Document containing the Intro text in a subsequent email.
A.I. All members should read and edit the Intro this week. Please send the edits back to Rick with a cc the group.
Goal is to finish this week, unless substantial edits require discussion.


- Discussing initiation and general organization of this project

-Group agreed that this e-paper would provide context to the Prioritization exercise and standardization directory.

Topics that may be included in e-Paper:

  • Why standardization at all? What are benefits?
  • Who are points of contact for standardization efforts?
  • How can people contribute to standardization (creating SENDIG pieces, sending test data, piloting)
  • Inclusion of directory of Standardization efforts, possibly with a recognition that the directory will be a snapshot for a document that is otherwise intended to be dynamic

-Part of the group discussion veered toward a need for consistant Agency involvement and encouragement of processes of standardization.
After the meeting, Bob conveyed this sentiment to Tim Kropp.
-The group suggested that the long-standing efforts to standardize may be further catalyzed by a gesture such as publication of the group’s Standards Roadmap on the Agency’s webpage.
-Bob will pursue whether this is in the realm of possibility once the project nears a more final product.
After-meeting note: perhaps the paper might include references to legislation and guidance which establishes the Agency’s commitment.

- Organizing our effort on e-Paper: The group discussed establishing focal efforts on topics based on our varied backgrounds. The topic was left open for further development.

Last revision by Dorsamr,08/29/2012