SEND Implementation User Group Minutes 2012-09-17

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When: 2012-09-17, 11:00am-12:00pm EST
Place: Telecon

Logistics

Attendance

Participant Attended
Lynda Sands X
Troy Smyrnios X
Jennifer Feldmann X
Jeff Foy X
Lou Ann Kramer
Bill Houser X
Frederic Mura
Louis Norton
Sarah Obbers
Debra Oetzman X
Audrey Walker X
Wenxian Wang X
Peggy Zorn X

Meetings

Next meeting: 2012-10-01, 10-11a EST

Minutes

Wiki

FAQ

Organization

  • Team reviewed org changes
  • Bill brought up the concept of referencing content from another question. When referring to another question, take the question title verbatim and reference in quotes. On a related note, when changing the title of a question, make sure to search for any cases where it is referenced. Troy to send out reminder to this effect in minutes notice email.
  • Guidelines/checklist for editing for team - Bill for initial draft; Troy to help
    • referencing questions
    • concept of bolding the question with a break after it
    • keeping question/answer concise
    • referencing FDA statement

Additional Content

  • DSEC FAQ obtained; needs to be added
  • Team seems to still have content for FAQ, just a matter of bandwidth
  • Peggy to add CT questions

Review of Unanswered Questions

  • PDUFA timelines TBD - Troy waiting on answer from note sent to Tim/edata to confirm PDUFA timelines/verbiage

FDA vs team opinion

  • Need link to general rules from FDA (which OpenCDISC uses) - the agnostic set

Forum

Ran out of time

General

New meeting time per whenisgood poll results. Recurring meeting will be shifted to 1 hour prior to current time (11-12 -> 10-11am EST)

Action Items

Responsible Task Timeframe
Troy Update recurring schedule to 10-11am EST Next telecon (10/1)
Troy Put DSEC FAQ questions in page Next telecon (10/1)
Troy Ask Tim if validation rules are posted somewhere central Next telecon (10/1)
Lynda General forum stickies (Welcome/Terms of Use) in Forum Outline page Next telecon (10/1)
Team Continue adding questions; review/refine answers to existing questions Next telecon (10/1)

Last revision by AudreyWalker,2012-09-17