Clinical and Translational Science Award
One Health Alliance
Clinical and Translational Science Award
One Health Alliance
Veterinary clinical trials are research studies that investigate the safety and effectiveness of new approaches to care for diseases that occur in companion animals. These studies are prospective in nature with the goal of discovering new and better ways to diagnose, treat, or prevent diseases that affect both pets and their owners.
Below is more information and training modules related to the conduct of veterinary clinical trials.
What ethical and scientific quality standards should be considered in designing, conducting, recording, and reporting veterinary clinical studies?
This 75-minute online training course is intended to introduce Veterinary Good Clinical Practices (vGCP) and geared towards any individual involved in the design, conduct, monitoring, recording, auditing, analysis and reporting of clinical studies in veterinary patients. Compliance with vGCP assures transparent data collection, humane treatment of veterinary patients, and integrity 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.
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 treatment of veterinary patients, 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.
DO YOU RECRUIT PARTICIPANTS FOR VETERINARY CLINICAL TRIALS?
This 15-minute online training course 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.
By the end of this training, you will be able to:
Any veterinary researchers, research coordinators, research nurses/veterinary technicians, practitioners, students, or other study members or individuals who might be involved in recruiting or enrolling veterinary patients in clinical trials are strongly encouraged to take this course.
This course was developed with funding from a Clinical and Translational Science Award One Health Alliance pilot grant and is offered at no cost.
COHA CLIENT CONSENT: BEST PRACTICES FOR VETERINARY CLINICAL TRIALS ILEARN MODULE
Are you designing a veterinary clinical trial? This self-paced course provides an introduction to risk management in veterinary clinical trials and guidance regarding best practices for managing those risks throughout a study. 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.
Learning Objectives By the end of this training, you will be able to:
Any veterinary PIs, research coordinators, research nurses, other study team members 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 trainings available associated with the conduct of veterinary clinical trials.
This course was developed with funding from a Clinical and Translational Science Award One Health Alliance pilot grant and is offered at no cost.
COHA RISK ASSESSMENT AND MANAGEMENT IN VETERINARY CLINICAL TRIALS ILEARN MODULE
This course is intended to provide information about the regulatory landscape related to veterinary clinical trials conduct in the United States. The course is intended for individuals involved in performing or supporting veterinary clinical trials and is divided into three parts. In part one, we will establish a foundational understanding of the current regulatory landscape. Part two provides a description of the regulatory steps needed before, during, and after conducting a veterinary clinical trial. We will end by exploring additional regulatory considerations in part three.
Throughout the course, we will use example scenarios and interactive elements to help you build your knowledge and understanding.
Learning Objectives By the end of this training, you will be able to:
Any veterinary PIs, research coordinators, research nurses, other study team members 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 trainings available associated with the conduct of veterinary clinical trials.
This course was developed with funding from a Clinical and Translational Science Award One Health Alliance pilot grant and is offered at no cost.
Regulatory Landscape of Veterinary Clinical Trials ILEARN MODULE