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Date: 14. März 2024, Donnerstag
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Kontakt: cdiscug@metronomia.net
Date: | 14. März 2024, Donnerstag | |||
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Location: | Metronomia Clinical Research GmbH Paul-Gerhardt-Allee 42 | Kontakt: | ||
Time | Topic | Who |
Time
Topic
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
10:30 | Phuse Template Reviewers Guide integrated ADaM pools (iADRG) | Steffi |
Idee
- Dataset-JSON (Alternative zu XPT)
10:50 | Break | |||
11:00 |
Pinnacle Community vs Enterprise Version vs CORE · Community Version Pinnacle · Enterprise Version Pinnacle · CORE | Andrea ( |
?) |
Stefan (?) Jozef |
12:00 |
Präsenter gesucht
JozefUnblinding: Erfahrungen, Umsetzungen, Probleme · TA, DM, EX, EC Umsetzung/ Erstellung | Andrea (? |
) | ||||
12:30 | Lunch and Get-Together | |||
13:30 | Estimands / Intercurrent Events in ADaM | Dennis, |
Jaclyn |
14: |
11:15
Break
30 | Biomedical concepts |
/ Unified Study Definition Model | Susanne B. |
12:30
Lunch and Get-Together
13:30
- DC domain / rescreenings
Markus ?
15:00 | Break | |||
15:15 | TLF Designer Präsentation (Analysis Results Standard (ARS)) | Bhavin Busa (online |
/remote) | ||||
16:15 | DC Domain / Re-screenings | Markus | ||
16. |
45 | CDISC |
New’s · New Standards (https://www.cdisc.org/standards/publications) · Pipeline (von US CDISC Interchange) | Monika |
- Topics of interest
- Next meeting / Meeting / Closing remarks
17:15 | Meeting end: Next Meeting / Closing remarks | Markus |
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