WHOART & COSTART
This terminology has been developed over more than 30 years to serve as a basis for rational coding of adverse reaction terms. Because new drugs and new indications produce new terms to be incorporated, the structure of the terminology is flexible enough to allow new developments to be incorporated without losing previous relationships.
Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) is the terminology developed and used by the Food and Drug Administration (FDA) for the coding, filing and retrieving of post marketing adverse reaction reports. It provides a method to deal with the variation in vocabulary used by those who submit adverse event reports to the FDA. Three new COSTART terms were added to this version and are integrated throughout the manual in the appropriate indexes. Most changes made were to the Glossary file.