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Good Clinical Practice (GCP) for Veterinary Clinical Trials​

The CTSA One Health Alliance (COHA) has developed an online training module to introduce Veterinary Good Clinical Practices (vGCP) to veterinary researchers, research nurses/veterinary technicians, study coordinators, and other relevant stakeholders. The 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 practices outlined in the course provides transparency regarding data collection methods, ensures humane treatment of veterinary patients, and supports integrity/reliability of data collected.

Consenting

COHA has also developed a 15-minute online training course that provides an overview of best practices for obtaining informed consent in clinical research with client owned animals (veterinary patients). Through this course, learners will review the essential elements that should be considered when putting together a consent form. These include readability, discussion of risks and benefits, other options for care, and the inclusion of a study calendar. Learners will also consider methods for ensuring that animal owners have ample opportunity to review trial requirements and ask questions. Obtaining consent under unique circumstances, like emergencies and in the remote setting, will also be reviewed.

Risk Assessment and Management in Veterinary Clinical Trials

COHA has developed a third course to provide an introduction to risk management in veterinary clinical trials and guidance regarding best practices for managing those risks throughout a study. In the 25-minute self-paced online course learners will explore four different phases of risk management: assessment, control, communication, and review. Particular attention will be paid to continuous assessment as well as strategies for identifying different types of risks. Learners will develop concrete strategies for managing risks in their own clinical research.

Regulatory Aspects of Veterinary Clinical Trials

Coming Soon