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Cardiovascular

Cardiovascular Studies Therapeutic Area User Guide v1.0

1.0
Release Date: 17 Oct 2014

Version 1.0 Provisional of the Cardiovascular Studies Therapeutic Area User Guide (TAUG-CV), released 2014-10-17, provides guidance on implementing the Study Data Tabulation Model (SDTM) to represent cardiovascular data in regulatory submissions. TAUG-CV v1.0 focuses on Acute Coronary Syndrome (ACS) and Cardiovascular Endpoints. The Cardiovascular Endpoints are also referenced in the Standardized Definitions for Cardiovascular and Stroke Endpoint Events in Clinical Trials document.