2023-03-14 / 30. CDISC DACH User Network Meeting / Sulzbach(Taunus)

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

              *  xxx (more ?)

Steffen Müller

Volunteer?

Dagmar Kottig-Roth

Dagmar Kottig-Roth

Dagmar Kottig-Roth

Volunteer(s)???

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   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

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