WG6 Tcon3 Meeting minutes 06052012

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PhUSE Standards Roadmap Tcon #3 - June 5th, 2012

Attendees: ALain, Bob, Geoff, Lou Anne, Lynda

Action Items Wrap-up:

Posted prior meeting minutes; Concept of Data, Storage, and Context (placeholders) added to Wiki Discussion Tab; Drafted the Welcome Letter for new participants;General solicitation for participation at FDA in roughly two weeks.

A.I. Bob will distribute the drafted Welcome Letter for general comment. We discussed trying to keep it simple since some information is on the Wiki.

Proposed Discussion

  • Approach on e-Paper

**How to focus initially

*** Guided by studies list (as resource while avoiding duplication)

  • Aim to prioritize elements and to characterize what factored into prioritization. Brainstorm on additional elements (toward data accessibility, storage)

**First steps: obtain feedback from your company over next two weeks.

** Have drafted list with

*Leave room for back-fill from other groups’ work
How to proceed

*Need smaller pieces with some approximate order, then go stepwise

Discussion at meeting-
The group briefly discussed how the proposed e-Paper could serve as an overarching document that gives context to the standards roadmap and standards directory.

The group discussed how to proceed for the next months... Using the SEND Roadmap Planning list (courtesy of Gitte, distributed by Bob), each member will take the studies list back to their companies to construct their own prioritized list. The idea is to prioritize the list of studies but also capture the rationale for choosing that order. We’ll share our lists and reasoning behind our list at our July 3rd meeting. These will serve as a foundation for the group to obtain a consensus list. Once we have a consensus list, we should consider whether we have scientists who can serve as subject matter experts who might add elements that we should consider when developing and finalizing our list. The idea is then to go down the list step-wise to consider whether each element on the list needs to be further developed. It is expected that this step-wise treatment will be conducted over several TCs. Some studies may be grouped and discussed at a single Tcon, while it is conceivable that a single study type may garner greater discussion, especially if we’ve invited a subject matter expert.

It was mentioned that the intro of the e-Paper may be easy enough to define, and that our roadmap prioritization exercise will likely spin off issues that can be developed in the e-Paper. This e-paper development can conceivably take place during our roadmap discussion, with greater focus on achieving an acceptable version of the e-Paper after our Roadmap discussions have run their course.

A.I. Bob distributes SEND Roadmap planning list

A.I. All: please use the studies list to develop a priorities list with your companies for discussion at July 3rd meeting