Agenda (copy of the slides ..... CDISC_IT_TC_20220330.pdf)
CDISC and Data Submission What’s New
SDTM and ADaM Update
Other Topics and Q&A
Additional Material:
- SDTM Ig 3.4 (SDTM Ig 3.4)
- SDTM v2.0 (SDTM v2.0)
- "ADaM IG 1.3" (ADaM IG 1.3)
- "ADaM Implementation Guide for Medical Devices" PharmaSUG 2021, Julia Yang, Karin LaPann, Silvia Faini (PharmaSUG-2021-MD-035.pdf)
- "ADaM IG 1.3" (ADaM IG 1.3)
- SDTM Ig 3.4 (SDTM Ig 3.4)
- SDTM v2.0 (SDTM v2.0FDA Catalogue of Standards Feb-2022 (Final_FDA Data Stds Catalog_2.15.2022 (v8.0).xlsx)