ABSTRACT
This chapter describes the practical steps taken to prepare the Final Study Report (FSR) of a clinical trial of a veterinary product. By way of introduction, these steps have evolved after extensive experience in animal drug studies, including ones conducted at a Good Laboratory Practice (GLP) or Good Clinical Practice (GCP) compliant level. These studies were undertaken by a university contract research organisation (CRO) solely dedicated to the purpose of aiding research and development (R&D) in the (global) animal health industry. Extensive resources, including animals, land, equipment and expertise are available within the university, and this research centre has effectively functioned as a project manager's office, with responsibility for evaluating clinical products and producing FSRs. The terms used in this chapter are consistent with the most recent Veterinary International Conference on Harmonisation (VICH) GCP guidelines (VICH 1998).
