Agenda (copy of the slides CDISC_IT_TC_20221214.pdf)
- CDISC and Data Submission What’s New
- CDISC Webinars and Events 2022/23
- Access to CDISC Library
- CDISC Knowledge Base
- Data Submission Regulatory Update
- PHUSE 2022 EU Connect Highlights
- Other Topics and Q&A
Additional Material:
- FDA Technical Study Data Conformance Guidance - October 2022 (3 - StudyDataTechnicalConformanceGuide_v5.0_Oct_2022_Final_0.pdf), Data Standard Catalogue (FDA Data Stds Catalog_8.01.2022 (v8.2).xlsx)
- "ADaM Traceability" (ADaM_Traceability_Examples_v1.0.pdf)
- "Yes you can access the SAS Library from SAS" (CDISC-2021-Europe-YesYouCanAccessCDISCLibraryFromSAS-Tinazzi-Paper.pdf) - Presentation from CDISC EU 2021
- "The Integration Dilemma", Angelo Tinazzi (PAP_SI09.pdf) - Presentation from PHUSE EU 2022