The conduct of clinical trials and good clinical practices: the sponsor's perspective. Food and Drug Administration.

The Guideline, "Conduct of Clinical Investigations: Responsibilities of Clinical Investigators and Monitors for Investigational New Animal Drug Studies," which was issued by the Center for Veterinary Medicine (CVM) in October 1992 is intended to improve standards of clinical research. The purpose of clinical trials is to obtain data to support dose selection and to confirm the dose for regulatory approval of New Animal Drug Applications (NADA). The processes and procedures described in the Guideline should improve the "fitness for use" of data from clinical trials. Clinical investigators who desire to work with drug sponsors must understand the tenor of the Guideline and implement its recommendations when conducting pivotal clinical research. Protocols in which procedures are clearly described and responsibilities for monitors and investigators defined, in concert with a preplanned definitions of source data supported by appropriate quality control and quality assurance procedures, will ensure that the basis of approval for new animal drugs is defensible.