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Showing posts with the label NDA

CDISC and its IMPLEMENTATION

An Introduction to CDISC: CDISC: Why SAS® Programmers Need to Know CDISC Implementation Step by Step: A Real World Example A Toolkit for CDISC Implementation CDISC standards How to test CDISC Operation data Model (ODM) in SAS Creating Case Report Tabulations (CRTs) for an NDA Electronic Submission to the FDA Implementation Guide Study Data Tabulation Model Update on CDISC Study Data Tabulation Model Practical Methods for Creating CDISC SDTM Domain Data Sets from Existing Data SAS® Dataset Content Conversion to CDISC Data Standards IMPLEMENTATION OF CDISC STANDARDS Sample CRF's and Protocol CRFs (PDF - 773.4 KB) Protocol (PDF - 2.0 MB) direct link: https://biolincc.nhlbi.nih.gov/studies/