ABSTRACT
Producing a protocol to comply with Good Clinical Practice (GCP) requirements is basically the same procedure for all clinical studies, plus specifics relative to the investigational veterinary product. There are also legislative requirements which have to be considered depending on the type of product being tested and the regulatory authority for which the final submission dossier is being prepared. This chapter therefore includes the basic inclusions for all protocols. Additional time during the preparation period may be needed if the protocol is to be reviewed by the relevant regulatory authority. This may occur where opinions may vary or clarification may be required on particular aspects of the study design. Discussion with the authorities does not, however, guarantee that they will accept the data from the study.
