Clinical study reports

Abstract

The clinical study report describes the results of a single human study and thus represents the most fundamental building block in a drug product’s argument for use in humans. The results of all human trials conducted by a drug or biologics company must be recorded in some type of report, although the type of reporting may vary. This chapter describes a clinical study report as defined by the International Conference on Harmonisation (ICH) in the E3 Guideline [1], which is the type of report used for most clinical studies conducted in the three major geographic regions (Europe, Japan, and the United States) and is referred to as a “full” clinical study report in this chapter.