SS 19Mar2013

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Meeting Record

01:00 pm - 04:30 pm, 18Mar2013; 10:00 am - 05:00 pm, 19Mar2013
Silver Spring Civic Center, Silver Spring, Marryland, USA
Hanming Tu
Hanming Tu
Eric Sun, Jens S. (FDA), Lina Jorgensen, Kirk Bateman, Musa Nsereko, John Garrit, Mike Carniello, Sara Modin, Sally Cassells, Wei Wang, Mary Nilsson, Qi Jiang, John Adams, Fabien Limay, Zhongjun Luo (FDA),

Sascha Ahvweilev, John Ferran, Dirk Van Krunckelsven, Ian Fleming, Frank Senk, Kevin Kane, Chris Le Gallo, Jack Averill, Joy Li (FDA), Steve Light, Dave handelsman, Scott Getzin, Hanming Tu


Day one
  • Giving background info (15 m) – Mat
    • History of sub-groups into eight projects
  • Working Group wiki pages (15 m) - Hanming
  • Group report (45 m) – Sally/Mary/Kevin
    • Intro to each of the eight projects
    • Q & A
    • Breakout to two sesions
  • Communication plan (30 m) – Dirk/Kevin
  • Break (15 m)
  • Finalizing platform – overview, guideline, roles, duties, issue tracking (.5 h) – Hanming
  • Demonstrating the platform for collaborating – brief demo (.5 h) – Hanming/Kevin/Mike C.
Day Two
  • Breakout Session 2: Process of using Google code and validation
    • Interactive workshop on how to use Google Code (1 h) – Hanming/Mike C.;
    • Process for creating standard scripts and documenting the process (1 h) – Kevin/Lina/Jean-Marc
    • Lunch
    • License, procurement, open source legal discussion (1 h) – Max/Mat/Sally/Kevin (1 h)
    • Validation process Kevin/Lina/Jean-Marc (.5 h)
    • Break
    • White paper overview Mary (30 m)
    • Action plan - assigning people to projects (1 h)

Action Plan

Action items for working group leads
  • Conduct every other week (twice a month) meetings
  • Coordinate the projects
General actions for project leads
  • Send email to Daniel Boisvert [] if you do not have right to edit the project wiki pages
  • Update the project wiki pages
  • Recruit members
  • Conduct every other week (twice a month) meetings and track the progress and discussion in meeting minutes
  • Compiling Metadata - Jack/Lina
  • Creating index page (rating, feedback, etc) - Ian F.
  • Volunteers for developing script for FDA Clinical Review Guidance
    • Script for 71.1.1- Mike C.
    • Script for - John G
    • Script for - Ted P.
    • Script for - Sara K.
  • Contact Chris Decker for contributor agreement (P04) - Sally C.
  • Look into copy right about papers and codes within the papers - Jean-Marc.
  • Add code to white paper 1 - Wei Wang, Frank S., Musa N.
  • Look into some technical issues (save/publish, rollback, lock, block-on, etc.) - Hanming T.
  • Process documentation (comment issue, save/publish, voting, packaging for download, etc.) - Kevin
  • Decision: we will not call "validation" just call "qualification".
  • The checklist over recommended requirements for a script, could be added to the Guidance: How to add a new script - Lina J.
  • A decision document about validation/qualification should be produced. - Lina J.
  • Research on "Disclaimer" - Kevin/Sally
  • Decision:
    • all the users who wants to contribute and work on scripts get "committer" role.
  • Look into the possibilities of using different licenses for individual script in Google Code - Kevin/Sally
  • Review validation doc (stamp: Q - Phuse; U: FDA, Comp X; V: Comp X, Y) - Sara K.

Last revision by Jmbodart,10/13/2015