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Time

Topic

Who

9:30

Registration

10:00


01

Welcome and introduction to Parexel

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Jens Fischer

Kurt Hellstern

10:10


10:55

02

CDISC Proof of Concept: Evolving our standards towards end to end automation


Discussion

Peter Van Reusel

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11:10

Break

11:30

03

End-to-End in my Company

Don’t we all pursue a step by step approach?

How far are we on this way?

Experience exchange

All - Petra, Michael, Chantal, Torsten, (Anja), (Markus)

(Bitte max auf 1 oder 2 Slides)

12:30

Lunch and Get-Together

13:30


14.30

04

An update on CDISC SHARE and how to use it


Medical Informatics Initiative (MII): Core Data Set as Basis for Recruitment for Clinical Trials in Germany‘s University Hospitals

Frederik Malfait


Christian Gulden (i.A. TMF)

15:00

Break

15:30

05

CDISC Primer (Agreed to be rescheduled in the meeting due to time constraints)

Working Group Homepage: https://www.phusewiki.org/wiki/index.php?title=CDISC_Implementation_Primer


CDISC related PhUSE working groups

Beate Hientzsch



Hasan Kantarci

16.00

06

Regulatory Updates /FDA Technical Conformance Guide

Marion Friebel

16.15

07

CDISC User Group Discussion

  • Overview SDTM IG 3.3 Updates
  • Annotated CRF Working Group update
  • Feedback: How is the GUN Wiki doing?
  • Topics of interest
  • Next meeting / Meeting / Closing remarks


All – Petra
Markus Stoll
Markus Stoll


17:00

Meeting end

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