DESD PSS: Study Design Structured Document - RCRIM

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Return to Domain Experts Electronic Voting Summaries

Please vote on the PSS for the RCRIM WG. Enter your name and WG along with your vote. 1 vote per WG. Poll open until 2/15/2012 unless quorum is reached earlier. Link to Document:

PSS for Study Design Structured Document

  • Summary - Passed (7/1/0/3)
    • Number of participants: 8
    • Most popular option: Affirmative
    • Votes in favor: 7
    • Comments: 3
    • Non-participating work groups counted as abstaining solely for the purpose of counting quorum: 0
Co-Chairs Affirmative Negative Abstain
Mead Walker (PSWG) OK
Edward Helton(RCRIM) OK
Joy Kuhl (Child Health) OK
Hugh Glover (Pharmacy) OK
Jim McKinley (AWG) OK
John Roberts (PHER) OK
Suzanne Gonzales-Webb OK
Jim McClay (EC-WG) OK
Count 7 1 0


Name Date Time Comment
Hugh Glover (part a) Friday, January 27, 2012 6:11:21 AM GMT-12:00 This is clearly stated as a US Realm project to meet an FDA need. However it is marked as meeting the strategic need of "development of global standards". The FDA is not "global" and creating an FDA specifc standard may be an impediemnt to development and implementation of similar standards elewhere - particularly given the global reach of Pharma and their understandable unwillingness to implement similar process in two different ways.
Hugh Glover (part b) Friday, January 27, 2012 6:13:26 AM GMT-12:00 I'd be happy to change my vote if the PSS gave some indication of how the project intended to assess and accomodate the potential requirements of other realms.
Edward Tripp Friday, February 3, 2012 3:51:46 AM GMT-12:00 Revised project Scope Statement to address comments by Hugh Glover.

PSS for Study Design Structured Document v1.6

NOTE: The following was received via email

From:	Hugh Glover []
Sent:	Friday, February 03, 2012 8:13 AM
To:	Garvey, Patricia
Cc:	Edward Tripp; Mead Walker; Oliva, Armando
Subject:	RE: Comments on the Doodle Poll to Approve PSS Study Design


Thank you for taking the time to address my concerns.  

I think the additional language you propose is helpful and recognizes the limitations of the  available 
sources of requirements, and identifies a group who will be expected to help.  I’m am happy that you 
wish to make these changes.


Link to Poll