2017-Dec-01 BiWeekly PhUSE Nonclinical ADA Endpoint Modeling

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<< Go back to the Investigating Endpoint Modeling - ADA Minutes Page When: 2017-12-01, 09:00-10:00 EDT
Place: Telecon

Logistics

Attendance

Participant Attended
Mike Wasko X
Gretchen Dean X
Thomas Bjerregaard X
Alan Brown
Christy Kubin
Janessa Pierce X
Jennifer Emeneggee
Joleen White
Joyce Ford
Kennan Marsh
Leslie Lorello X
Rihab Kordane
Stephen MacMannis
Trina Jiao
Wendy Freeburn
William Houser
Susan Steen X
Anna Pron-Zwick
Dennis Stocker
Jordan Li
Lauren White X
Jason Rogers X


Meetings

Next meeting: Aug 25, 2017 at 09:00 to 10:00 EDT

Meetings: 2 week schedule

Minutes

Minutes Courtesy of Gretchen Dean I took down the following notes from today’s meeting that can be used as minutes:

1) Reviewed slides from Joleen White which capture the modeling approach and also contain schematics of the various testing strategies

2) Thomas will review his examples in excel file and see if it adds value to add some detail to capture more complicated testing scenarios

3) Participants are asked to send to Thomas examples of units used to capture quasi-quantitative data (titre, RLU, etc…)

4) Need to check on ISTSTDTL – is it in a published standard? Would like to have this as expected but not required.

5) Need guidance on how to socialize the proposal broadly – SEND and SDTM related groups. Need to seek guidance from Bill, LouAnn, Sue D., Craig Z., others?

 Do we need to kick off a cross functional team?  Have we engaged with MB team enough?

Action Items

Responsible Task Timeframe
Mike Update Wiki Next few days
Group Each member to track down an example of data set used in submission for clinical (SDTM). Will likely need to reach out to clinical data management function within your organization (target 1 month) By next meeting
Group Future meeting – share example of anonymized/mock data (Leslie and Thomas – 8/11 & 25) Can be shared in excel format. By next meeting



Last revision by Mwasko79, 2017-12-1