Version 1.0 of the Cardiovascular Studies Therapeutic Area User Guide (TAUG-CV) was developed under the CFAST program and the CDISC Standards Development Process. The 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.
TA Standards extend the Foundational Standards to represent data that pertain to specific indications within disease areas. CDISC Standards specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints.
Public Review Comments
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.