Page History

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

• CDISC New’s 
  • New Standards (https://www.cdisc.org/standards/publications)
  • Pipeline (von US CDISC Interchange)

Präsenter gesucht

Idee

• COSA / CDISC360: Punkte aus tools of interest

Präsenter gesucht

Idee

• CDASH Update: Mapping zu SDTM

Präsenter gesucht

• Phuse Template Reviewers Guide integrated ADaM pools (iADRG)

Steffi

Idee

• Dataset-JSON (Alternative zu XPT)

Präsenter gesucht

• Pinnacle Community vs Enterprise Version vs CORE
  • Community Version Pinnacle
  • Enterprise Version Pinnacle
  • CORE (Jozef)
  • Unterschiede, Möglichkeiten, Zukunft
  • FDA, PMDA: Vorgaben?

Präsenter gesucht

Jozef

• Unblinding: Erfahrungen, Umsetzungen, Probleme
  • TA, DM, EX, EC Umsetzung/ Erstellung

Andrea ? 30 min

NEW

• Estimands / Intercurrent Events in ADaM

Dennis, Jacyln (Metronomia) 1 h

11:15

Break

11:30

• Biomedical concepts oder ADaM Metadata Submission Guidelines v1.0

Susanne B.

12:30

Lunch and Get-Together

13:30

Markus ?

14:45

Break

15:15

TLF Designer Präsentation (Analysis Results Standard (ARS))

Bhavin Busa (online) 1h

16.30

CDISC User Group Discussion

• Topics of interest
• Next meeting / Meeting / Closing remarks

Markus and all

17:15

Meeting end