Year Published: 2019

Time to Complete: 75 min

Instructor: The CTSA One Health Alliance (COHA)

Learning Level: Fundamental

Primary Audience: Researchers

Prerequisite: None

Skills Domain: Clinical Study Operations (Good Clinical Practice)

What standards of practice should be considered in designing, conducting, recording, and reporting veterinary studies that involve client owned animals?

This 75-min online training course is intended to introduce concepts and regulatory guidance associated with Veterinary Good Clinical Practice (vGCP). The guidance recommendations for vGCP were developed under the principles of the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and provides a unified standard for the European Union (EU), Japan and the United States of America (USA) to facilitate the mutual acceptance of clinical data by the relevant regulatory authorities. This course covers the design, conduct, monitoring, recording, auditing, analysis and reporting of clinical studies that involve veterinary patients (client owned animals) as outlined in the VICH GL9 guidance document. While compliance with VICH GL9 is not mandatory, following the standard practices outlined in this course provides transparency regarding data collection methods, ensures humane treatment of veterinary patients, and supports integrity/reliability of data collected. Each module provides you with key definitions and methodological insights to keeping the premise of data integrity and quality of veterinary study operations.

Any veterinary researchers, research nurses/veterinary technicians, study coordinators or other relevant stakeholders are strongly encouraged to access part or all of this course according to their interest and/or knowledge gap. Those who complete 80% of the course content and pass the associated quiz will receive a Course Completion Report endorsed by The Clinical and Translational Science Award One Health Alliance (COHA) and Tufts Clinical and Translational Science Institute (CTSI). This Certificate is one of few specialized GCP trainings available that addresses regulatory guidance associated with the conduct of veterinary clinical trials. You may present this certificate as evidence of vGCP training to your study sponsor or other relevant regulatory entities.

Learning Objectives

After completing this course, you will be able to:

  • Provide an overview of veterinary Good Clinical Practice (vGCP).
  • Describe rigorous and standardized methods to collect and document study data.
  • Discuss methods to assess, thoroughly document, and report adverse events experienced by study patients.
 This Course is Free