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Für Event “CDISC DEUN Usergroup Meeting”


(Planned draft Agenda as of

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13-Feb-2023)

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Date:                    14 March 2023

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Kontakt: katrin.besch@mainanalytics.deCurrent Agenda - Last update 2023-02-13


Time               

Topic                                                                                                       

Who                                        

9:30

Registration

All

10:00

Welcome and introduction to mainanalytics


Beate Hientzsch

Markus Stoll

10:10

Focus Session

    ·  FDA CDISC Standards “requirements” in 2023                       

       o   Define-XML v2.1 - What’s New

       o   Technical Conformance Guide – Updates?                    

       o   SDTM-IG v3.3 / v3.4 - What’s New                                 

              *  SV

              *  LB/MB/IS

              *  GF

              *  PR, AE CE, EG, EC, VS, FT, FA, TS, QS, SC, SE
                  plus Model SDTM v1.8 to v2.0



Steffen Müller

Marion Friebel?


Dagmar Kottig-Roth

Dagmar Kottig-Roth

Dagmar Kottig-Roth

Judith Köpperth

11:15

Break


11:30

Continue CDISC Standards discussion…


    ·  FDA vs PMDA - Discussion


    ·  CDISC Outlook 2023

       o   Expected updates

All


All



t.b.d.

12:30

Lunch and Get-Together


13:30





14:15



14:30

CDISC COSA Initiative

    ·  COSA Introduction

       o   CDISC Hackathon: "admiral" - Insights

       o   Tool Presentation


DEUN UG TOI-Initiative - Tools of Interest Presentations

    ·  Status + Outlook 2023


CDISC Library for Dummies – First Steps

    ·  Data Standard Browser

    ·  API Remote Access – How To


Markus

Andrea Weber

Volunteer(s)?


Markus




Volunteer?

Volunteer?

15:00

Break


15:30

CDISC - Hidden Details

    ·  COVID-TAUG 

       o   SDTM

       o   ADaM Component


    ·  CT Relationships


    ·   Dictionaries in define.xml

       o   Define CT


    ·   LB domain History



Volunteer?

Volunteer?


Volunteer?



Volunteer?


Volunteer?

16.00

CDISC User Group Discussion

    ·  Poll - Usergroup Steering Committee

    ·  Topics of interest

    ·  Next meeting / Meeting / Closing remarks


Markus Stoll and all


17:15

Meeting end





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