SEND Implementation User Group Minutes 2016-02-15

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When: 2016-02-16, 10:00am-11:00am EST
Place: Telecon

Logistics

Attendance

Participant Attended
Troy Smyrnios X
Lynda Sands
Audrey Walker
Bill Houser X
Carrie X
Cheryl Sloan X
Dan Potenta X
Debra Oetzman
Donna Danduone
Frederic Mura
Jennifer Feldmann
Jeff Foy X
Kathy Powers
Kev Martin
Linda Hunt
Lou Ann Kramer
Louis Norton
Mike Wasko X
Pam Hills-Perry
Peggy Zorn
Sarah Obbers
SJ
Wenxian Wang


Meetings

Next meeting: 2015-03-07 10-11am EST

Meetings: 4 week schedule

Minutes

General

Forum

Links:

Review Forum

  • Question on PC/PPTEST
    • Drugs not being generic - populate with real drug name
    • Truncation - names most natural to use are congenial to truncation (not beginning with number)
    • (ACTION ITEM - Troy; Bill/Carrie review) Add FAQ item including some additional clarity for the PC/PP TEST/CAT/SCAT population with rules and realistic example
      • 1) PCTESTCD limit to 8 characters, no special characters and cannot begin with a number
      • 2) PCTEST limit to 40 characters
      • 3) PCTESTCD and PCTEST is a 1:1 relationship
      • 4) PPCAT must equal a PCTEST value
  • Question on CT - good as is answered currently
  • Question on Animal-level comments - good as is
  • Question on precision - collected vs reported
    • ORRES and STRESN should be same fundamental value
    • Not only collected vs reported, also can be different display precisions in LIMS, reporting systems, constraint on client PC, etc.
    • Use case: pure operational?
    • No one would likely ever notice a difference with ORRES, so STRESN/STRESC are the most important
    • (ACTION ITEM - Troy) Add FAQ item for precision handling wrt ORRES and STRESN/STRESC
      • STRESN/STRESC reported value
      • ORRES and STRESN same fundamental value - rounding could be argued as no fundamental change as long as done appropriately - not technically legal, but also a lot easier for a reviewer or consumer to understand
      • Could do SUPP to store raw value
      • Could split operational vs regulatory submission - e.g., operational case where rawest of value should be sent to aggregator organization
      • These are ideas/thoughts - jury is still out
  • Question on validator and comment 1 - ok as is
  • Question on validator and ug/mL unit - ok as is
  • Question on validator errors with test/testcd - combo of typos and validator errors
  • Question on PC / PP - ok as is
  • Question on extension of TRTV - answered
  • Question on start and end date - ok as is
  • Question on DOSENDTC and SEENDTC - ok as is
  • Question on another free option for validator - answered
  • Question on define 2.0 - answered
  • Question on POOLID in PC - base question as is - still a question on there though about examples in winnonlin
  • Question on PCLLOQ - ok as is
  • Question on PCEXCLFL - answered


Review News Page

SEND Implementation News

  • Carryover*
    • Concept of shared industry calendar
      • Laura has a google calendar and is curating
      • Might be issue on ownership (plenty can update, but still one owner)
      • Ready for mass use
      • Would need steps for people who aren't familiar with
      • (ACTION ITEM - Laura) Set public settings?

Wiki

  • Handling of SEND in Study Documentation
    • Current text is now wrong, after some paradigm shifts/discussions/etc.
      • SEND datasets not done under the time span of the GLP study
      • but if datasets are used for interpretation, then they are part of the GLP study, and thus need to abide by all that entails
      • sponsor responsible for ensuring that the datasets accurately represent the study
    • Text from Debra:
      Appropriate verifications need to be done to ensure that data in the SEND datasets are an accurate representation of study data. A positive statement needs to be included in this section. In the event of a directed audit of the data set integrity, the actual verification documentation would most likely be helpful to the auditor.
      An example of a statement is:
      “Data in the SEND datasets are an accurate representation of the data for Study No. 12345. Any differences between the data sets and the report are described in section 6.2. Verification procedures and documentation supporting this are available upon request.”
    • (ACTION ITEM - ?) Update pages:
    • Defer for now

--Carryover--

  • Known Issues
    • Many of these issues are 3.0 and have been fixed in 3.1
    • End of summer for 3.1 - circle back at that time to discuss what should be on this page

Action Items

Responsible Task Timeframe
Troy/Bill/Carrie Add FAQ item clarifying PC/PP TEST/CAT/SCAT (see below) Next meeting
Troy/Bill/Carrie Add FAQ item clarifying ORRES/STRESN/C (see below) Next meeting
 ? Update pages discussing QA/Validation/SD (see above) Next meeting
Bill Set up "SEND Calendar" / Talk with Laura about trying out wiki page Next meeting
Debra Draft an FAQ item for how to deal with multiple treatments in TX (per forum question) Next meeting
  • (ACTION ITEM - Troy; Bill/Carrie review) Add FAQ item including some additional clarity for the PC/PP TEST/CAT/SCAT population with rules and realistic example
    • 1) PCTESTCD limit to 8 characters, no special characters and cannot begin with a number
    • 2) PCTEST limit to 40 characters
    • 3) PCTESTCD and PCTEST is a 1:1 relationship
    • 4) PPCAT must equal a PCTEST value
  • (ACTION ITEM - Troy) Add FAQ item for precision handling wrt ORRES and STRESN/STRESC
    • STRESN/STRESC reported value
    • ORRES and STRESN same fundamental value - rounding could be argued as no fundamental change as long as done appropriately - not technically legal, but also a lot easier for a reviewer or consumer to understand
    • Could do SUPP to store raw value
    • Could split operational vs regulatory submission - e.g., operational case where rawest of value should be sent to aggregator organization
    • These are ideas/thoughts - jury is still out

Last revision by Mwasko79, 2016-02-26