CV Data Standards: May 2014 Progress Report

by Rebecca Wilgus

An important milestone for the cardiology data-standards initiatives was reached when the inaugural CDISC Cardiovascular Therapeutic Area User Guide (CVTAUG) was released for public comment through the CDISC data-standards development process. The User Guide provides guidelines and instructions for representing Cardiovascular Endpoint data elements and select Acute Coronary Syndrome data elements in the CDISC Study Data Tabulation Model (SDTM). Ongoing work to develop related controlled terminology continues. Collectively, the User Guide, related model, and controlled terminology are tools to support standardized collection and regulatory reporting of cardiovascular research data. Initial development of the data elements, model, and terminology represented in the CVTAUG was funded by FDA grant 1R24FD004411-01 and NHLBI grant 1RC2HL101512-01. Contributing team members include Drs. James Tcheng (PI, Professor in Cardiology) and David Kong (Co-PI, Associate Professor in Cardiology) and Robert Anderson (DCRI), James Topping (DCRI), Rebecca Wilgus (DCRI), and Brian McCourt (DCRI); Maria Isler (ACC); and Steve Kopko and Amy Palmer (CDISC).