Adverse Reaction Terminology Standardization: A Report on Schering-Plough's Use of the WHO Dictionary and the Formation of the WHO Adverse Reaction Terminology Users Group (WUG) Consortium

Abstract

Schering-Plough Corporation is using the WHO Adverse Reaction Dictionary for coding, storing, retrieving, and reporting on adverse effects through all phases of its clinical studies. The advantages of using the WHO dictionary include: (a) a standard consistent terminology and (b) an accepted international authoritative body supporting the terminology. Schering-Plough Corporation's implementation of the dictionary has enabled the development of an automatic adverse reaction encoding mechanism which will save more than 2 man-years of effort per year (internal estimate). In addition, the system provides for extremely easy and flexible retrieval, reporting, and dictionary updates. Ten pharmaceutical companies have joined together to form the WHO Users Group. The FDA and WHO have been very supportive of this effort. This group has undertaken the task of consolidating and standardizing the use of the WHO dictionary.