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| Date: | 14. März 2024, Donnerstag | |||
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Location: | Metronomia Clinical Research GmbH Paul-Gerhardt-Allee 42 | Kontakt: | ||
Time | Topic | Who | ||
9:30 | Registration | All | ||
10:00 | Welcome and introduction to Metronomia | Judith K., Markus S. | ||
10:10 | Update FDA Technical Conformance Guide Folien: 2024-03-14_01_PAREXEL GUG Meeting_Marion Friebel.pdf | Marion F. | ||
10:30 | Phuse Template Reviewers Guide integrated ADaM pools (iADRG) | Steffi S. | ||
10:50 | Break | |||
11:00 | Pinnacle Community vs Enterprise Version vs CORE · Community Version Pinnacle Folien: 2024-03-14_03_P21Community_Andrea Weber.pdf · Enterprise Version Pinnacle Folien: 2024-03-14_04_Additional Features of Pinnacle 21 Enterprise_Stefan Bordasch.pdf · CORE | Andrea W. Stefan B. Jozef A. | ||
12:00 | Unblinding: Erfahrungen, Umsetzungen, Probleme · TA, DM, EX, EC Umsetzung/ Erstellung Presentation: 2024-03-14_06_CDISC Unblinding_Andrea Weber.pdf | Andrea W. | ||
12:30 | Lunch and Get-Together | |||
13:30 | Estimands / Intercurrent Events in ADaM Folien: 2024-03-14_07 Estimands and ICEs in ADaM_Jaclyn Amberg.pdf | (Dennis K.,) Jaclyn A. | ||
14:30 | Biomedical concepts / Unified Study Definition Model Folien: 2024-03-14_08_BiomedicalConcepts_Susanne Bracht.pdf Teil zu Unified Study Definition Model (USDM) wird in einer der monatlichen TCs nachgeholt | Susanne B. | ||
15:00 | Break | |||
15:15 | TLF Designer Präsentation (Analysis Results Standard (ARS)) | Bhavin Busa (online/remote) | ||
16:15 | DC Domain / Re-screenings Präsentation wird in einer der monatlichen TCs nachgeholt | Markus S. | ||
16.45 | CDISC New’s · New Standards (https://www.cdisc.org/standards/publications) · Pipeline (von US CDISC Interchange) | Monika K. | ||
17:15 | Meeting end: Next Meeting / Closing remarks | Markus S. | ||
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