SEND Implementation User Group Minutes 2014-06-30

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When: 2014-06-30, 10:00am-11:00am EST
Place: Telecon

Logistics

Attendance

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


Meetings

Next meeting: 2014-07-28 10-11am EST

Meetings: 4 week schedule

Minutes

General

  • New members


Forum

Links:


Broadcasting presence of forum capability

Forum page has been visited a lot, but not too many questions asked. Need to socialize.

  • Additional outlets:
    • (Troy) CDISC: ping Diana on adding to newsletter and adding to the SEND page where IG is posted (links to wiki/forum)
    • (Troy) PhUSE: ping on adding to PhUSE newsletter
      • 2014-06-30: pinged but redirected to different person; might be better to put in with working group updates
    • (Jeff) SOT, Regulatory section: ask about getting an article in one of the quarterly newsletters - main and/or regionals. Jeff will ask on what type of format, etc. they'd expect
    • (Jeff) ACT: Jeff may know a contact to give a first shot at it
    • (Donna) The IQ group (http://iqconsortium.org): cold call
  • (Troy) Core team item - socialize to core team:
    • Forum as avenue for asking questions / subscribing / etc.
    • News page
    • 2014-06-30: Debra talked to it a bit in last meeting; to be expounded on in future core meeting.

Complete:

    • (Troy) SQA: Ping Connie again on adding to newsletter - ask about local affiliates
      • 2014-06-30: complete
    • (Peggy) STP: ask Charlotte and Dawn about this since inhand's in with them. Possible expansion to international versions.
      • 2014-06-02: Charlotte - said this is on the STP SEND page - link to the wiki. Maybe add link to the forum as well?
      • 2014-06-30: they have a link up there - complete
    • (Cheryl) Teratology Society: has contact email on site; will see if we can loop in
      • 2014-06-02: Email sent - some response on middle atlantic reproduction and teratology association; haven't heard back from main group
      • 2014-06-30: Complete
  • (Troy) wikipedia: update wikipedia entry to include more links, plus some text on forum
    • 2014-06-02: Links and text - needs fix on FDA data standards link
    • 2014-06-30: Updated
  • (Troy) CRO distribution/marketing (email):
    • CRL: Audrey
    • Covance: Debra
    • MPI: Steve
    • Huntingdon: Tom
    • 2014-06-30: complete


Review Forum

  • Reviewed 2 questions, proposed 3 entries for the FAQ:

Q: If animals are scheduled to have findings in the future (e.g., at terminal sacrifice) and the animals are removed from the study early (e.g., unscheduled sacrifice), how should findings be represented (e.g., with VISITDY, --STAT, and --REASND)?
A: Only in the instance where you carry out a planned assessment according to the plan (within the grace days that you have defined for that VISITDY), can you populate a record with VISITDY information. All other instances must be considered unscheduled activities and cannot have a populated VISITDY.
Findings that were originally planned for an animal removed early from study are not required to be artificially inserted into the SEND datasets (e.g., with a --STAT of NOT DONE).

Q: When the protocol is amended during the study to change planned activities, when/how should VISITDY be populated?
A: As soon as the schedule changes by amendment, that is now the plan, and so VISITDY should be populated with the amended planned date(s). For example, if a group is decided to be sacrificed early by protocol amendment, then the corresponding disposition records would have VISITDY populated.

Q: How should the --DTC/--DY variables be populated in cases where --STAT=NOT DONE?
A: When --ORRES cannot be populated, --STAT and --REASND take the place of --ORRES and thereby represent the outcome of the --TEST. In that instance, --DTC and --DY describe the outcome indicated by --STAT and --REASND. If you are collecting timing information about missing results for planned tests, then you should indeed populate the --DTC and --DY with this information (e.g., the date when the planned test was marked missing).


Review News Page

News link

  • (Peggy) New CT Package for Review (package 19)
  • (Peggy) CT Package released to production (package 18)

Wiki

  • Reviewed update to the When Is SEND Mandatory? question (study start requirement is now 24 months after final guidance)

Action Items

Responsible Task Timeframe
Troy Email Diana from CDISC on adding to newsletter and adding to the SEND page Next meeting
Troy Email PhUSE on adding to newsletter Next meeting
Jeff Ask Regulatory section of SOT regarding getting in the newsletter Next meeting
Jeff Contact ACT contacts Next meeting
Donna Contact the IQ group (http://iqconsortium.org) Next meeting



Last revision by Troy.smyrnios, 2014-06-30