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Time               

Topic                                                                                                                               

Who                                                              

9:30

Registration

All

10:00

Welcome and introduction to Metronomia

Metronomia (TBD), Markus Stoll

10:10

• CDISC New’s 
  • New Standards (https://www.cdisc.org/standards/publications)
• Bhavin Busa – TLF Designer Präsentation?
• Update FDA Technical Conformance Guide (Marion?)
• CDISC New’s -> mehr Informationen einholen bis zur nächsten TC (Markus, Steffi, Judith)
  • New Standards
  • Pipeline (von US CDISC Interchange)
• COSA / CDISC360: Punkte aus tools of interest
• CDASH Update: Mapping zu SDTM
• Phuse Template Reviewers Guide integrated ADaM pools (iADRG)
• Dataset-JSON (Alternative zu XPT)
• Pinnacle Community vs Enterprise Version vs CORE
  • Community Version Pinnacle
  • Enterprise Version Pinnacle
  • CORE (Jozef)
  • Unterschiede, Möglichkeiten, Zukunft
  • FDA, PMDA: Vorgaben?

• Update FDA Technical Conformance Guide

Marion ?

• Phuse Template Reviewers Guide integrated ADaM pools (iADRG)

Steffi

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

Andrea ? 30 min

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 ?

14:4515:00

Break

15:3015

TLF Designer Präsentation (Analysis Results Standard (ARS))

Bhavin Busa (online) 1h

16.0030

CDISC User Group Discussion

    ·  Topics of interest

    ·  Next meeting / Meeting / Closing remarks

Markus Stoll and all

17:15

Meeting end