PhUSE Nonclinical WG – Application of SEND data for analysis

AGEnDA/Minutes

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2015-12-04
/ Telecon/WebWebEx / 10:00 am – 11:00 am (EST)
4:00 pm – 5:00 pm (CET)
Meeting Organized by / Gitte Frausing & Laura Kaufman
MEETING PURPOSE / Discussion of use cases for analysis of SEND data
Attendees / Present / Name / Company
Anisa Scott / SAS Institute
X / Dan Potenta / Novartis
X / Gitte Frausing / Data Standards Decisions
Jillian Sanford / PointCross Life Sciences
Laura Kaufman / PDS Life Sciences
Lynda Sands / GlaxoSmithKline
Montserrat Cases / Bayer Pharma
Paul Brown / FDA
X / Rachel Harper / Covance
Richard Buchanan / PDS Life Sciences
X / Rihab Kordane / Charles River Laboratories
Robert Dorsam / FDA
X / Thomas Gade Bjerregaard / Novo Nordisk
Wenxian Wang / Xybion

Agenda topics

1.CL examples

/ The group went through the first to pages of the CL example from Rachel. It was discussed that the sessions in the CL table are sometimes scheduled and sometimes triggered by previous observations. SEND does not come with a good way of distinguishing between the following types of observations:
  • The minimum schedule
  • The extended triggered schedule
  • True unscheduled observations
An example of a triggered schedule could be that the animal is showing subdued behavior in the first observation session. The technician will then be prompted during session 2 to look for this sign in the animal. If no signs are present in session 2, the animal will get a record of NORMAL. If other signs are present, only records with these signs will be shown (and be represented in the SEND dataset).
The absence of a follow-up record (sign – not present) does not allow for the possibility to track the duration of a clinical sign. The absence of information could mean several things in this instance: 1) you looked and didn’t find it, 2) you didn’t look
SEND datasets does not come with information about when observations are triggered, so when to reasonably expect a record (either with a result or NOT DONE).
These notes will be forwarded to the SEND team for consideration when dealing with protocol information going forward.

2.Next meeting

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Continue CL examples form Rachel and Wenxian

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