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Regulatory requirements for veterinary clinical studies have developed over the last 24 years. This paper covers the current best practice for the clinical study monitor. The monitor carries out a key role in clinical studies that is not sufficiently recognised; they may be active in all aspects of a clinical study. It is the purpose of this paper to describe and qualify these activities as outlined in the VICH GCP guidelines that currently represent best practice for clinical study performance.
This document is based on and develops the guidance found in VICH GL9, it should be noted that there are specific requirements and terminology, in for example, the Food and Drugs Administration's Code of Federal Regulations (CFR), CVM Guidance Documents, in EU Directives and EMEA guidelines that may be applied to veterinary clinical studies. The reader is directed to their national legislation for consideration of these items. This is of particular importance in the United States where the FDA may audit clinical studies against the detail of the appropriate CFR. No regulatory inspection for veterinary clinical study practice is carried out in the EU.
RQA Animal Health Committee and SQA Animal Health Speciality Section