The Role of the Monitor in Veterinary Clinical Studies eBooklet

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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.

Contents

1. Monitor Training and Qualifications
2. Protocol, Case Report Forms and the Final Study Report
3. Amendments, Deviations and Notes to File, Data Quality Control, Clean up and Review
4. Investigator, Site and Laboratory Selection
5. Investigational and Control Veterinary Products, Adverse Events and Pharmacovigilance
6. Compliance with Standard Operating Procedures, Protocol and Good Clinical Practice
7. Monitoring Visits and Visit Reports
8. Quality Assurance
9. References
10. Glossary
11. Web Links for Reference to GCP for Veterinary Studies
12. Publications
13. Appendix 1: Example of Instructions to the Investigator
14. Appendix 2: Example of Personnel Signature Form
15. Appendix 3: Example of Pre-Study Training Form
16. Appendix 4: Example of Investigator Checklist
17. Appendix 5: Example of Study Site Checklist
18. Appendix 6: Example of Clinical Laboratory Checklist
19. Appendix 7: Example of Site-Closure Checklist

Authors

RQA Animal Health Committee and SQA Animal Health Speciality Section

ISBN

978-1-904610-26-7

Published

March 2013