Critical path initiative: standardizing trial data.(Regulatory and Safety Action)

United States of America--The Food and Drug Administration (FDA) has announced development of the Study Data Tabulation Model (SDTM) (1) for sponsors of human drug clinical trials. It is expected that this will lead to greater efficiencies in clinical research and FDA reviews of new drug applications (NDAs). The SDTM represents an important step to accelerate research through the use of standards and health information technology. In addition, the adoption of the standard is consistent with the FDA's Critical Path initiative because it will help automate the largely paper-based clinical trials research process and foster easier communication and collaboration among clinical …