''Computerized Systems Used In Clinical Trials (CSUCT)'' is a guidance document established by the

U.S. Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...

in 1999 and revised in 2007. It is legally binding in the

United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territorie ...

References

External links

Text of the guidance
Food and Drug Administration {{US-gov-stub