Time | Topic | Who |
9:30 | Registration | All |
10:00 | Welcome and introduction to Metronomia | Metronomia (TBD), Markus Stoll |
10:10 | - CDISC New’s
- COSA / CDISC360: Punkte aus tools of interest
- CDASH Update: Mapping zu SDTM
- 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?
| Präsenter gesucht |
| - 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 ? |
14:45 | Break |
|
15:15 | TLF Designer Präsentation (Analysis Results Standard (ARS)) | Bhavin Busa (online) 1h |
16.30 | CDISC User Group Discussion · · - Next meeting / Meeting / Closing remarks
| Markus Stoll and all
|
17:15 | Meeting end |
|