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name31st German CDISC UN Agenda 20240314 draftv1-0.docxpdf
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Date:                    14. März 2024, Donnerstag

...

Kontakt: cdiscug@metronomia.net

                                                                                                                                                                                                                                                                          


Date:

14. März 2024, Donnerstag

Location:

Metronomia Clinical Research GmbH

Paul-Gerhardt-Allee 42
81245 München

Kontakt:

cdiscug@metronomia.net

Time

Topic

Who

Time               

Topic                                                                                                                               

Who                                                              

9:30

Registration

All

10:00

Welcome and introduction to Metronomia

Metronomia (TBD), Markus

10:10

Update FDA Technical Conformance Guide

Marion

?

Idee

Präsenter gesucht

Idee

  • COSA / CDISC360: Punkte aus tools of interest

Präsenter gesucht

Idee

  • CDASH Update: Mapping zu SDTM

Präsenter gesucht

10:30

Phuse Template Reviewers Guide integrated ADaM pools (iADRG)

Steffi

Idee

  • Dataset-JSON (Alternative zu XPT)

10:50

Break


11:00

Präsenter gesucht

Pinnacle Community vs Enterprise Version vs CORE

·         Community Version Pinnacle

·         Enterprise Version Pinnacle

·         CORE


Andrea (

Jozef

?)

  • Unterschiede, Möglichkeiten, Zukunft
  • FDA, PMDA: Vorgaben?
  • Stefan (?)

    Jozef


    12:00

    Präsenter gesucht

    Jozef

    Unblinding: Erfahrungen, Umsetzungen, Probleme

    ·         TA, DM, EX, EC Umsetzung/ Erstellung

    Andrea (?

    30 minNEW

    )

    12:30

    Lunch and Get-Together


    13:30

    Estimands / Intercurrent Events in ADaM

    Dennis,

    Jacyln (Metronomia) 1 h

    Jaclyn

    14:

    11:15

    Break

    11:

    30

    Biomedical concepts

    oder ADaM Metadata Submission Guidelines v1.0

    / Unified Study Definition Model

    Susanne B.

    12:30

    Lunch and Get-Together

    13:30

    • DC domain / rescreenings 

    Markus ?

    14:45

    15:00

    Break


    15:15

    TLF Designer Präsentation (Analysis Results Standard (ARS))

    Bhavin Busa (online

    ) 1h

    /remote) 

    16:15

    DC Domain / Re-screenings

    Markus

    16.

    30

    45

    CDISC

    User Group Discussion

    New’s

    ·       New Standards (https://www.cdisc.org/standards/publications)

    ·       Pipeline (von US CDISC Interchange)

    Monika

    • Topics of interest
    • Next meeting / Meeting / Closing remarks
    Markus and all

    17:15

    Meeting end: Next Meeting / Closing remarks

    Markus


                                                                                                                                                                                                                                                                              

    Anfahrt:

    Mit dem Auto:

    Sag Google Maps oder Deinem Navi:

    ...