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.

Content Outline

  • Introduction, Purpose and Objectives
  • Module 1. What is Veterinary Good Clinical Practice (vGCP)?
    • Describe the concept of Good Clinical Practice (GCP) and its rationale.
    • Discuss the characteristics of a veterinary clinical study that involves client owned animals.
    • Recognize the role of VICH GL9 as a regulatory guidance document for veterinary clinical studies.
  • Module 2. Personnel: Roles and Responsibilities
    • Identify typical personnel involved in a veterinary clinical study.
    • Compare and understand responsibilities across personnel roles.
    • Define study documentation requirements regarding personnel involved in a veterinary clinical study.
  • Module 3. Data: Study Protocol
    • Define the role of a study protocol and its various elements.
    • Describe what a study deviation is and what actions need to be taken following a deviation.
    • Define what protocol amendments entail and associated action steps.
  • Module 4. Data: Raw Data
    • Discuss what raw data means and how it applies to veterinary clinical studies.
    • Categorize different types of raw data that may be included in veterinary studies.
    • Describe all elements of raw data records to be collected and maintained as part of a veterinary clinical trial.
  • Module 5. Data: Assessing Adverse Events (AE)
    • Define the meaning of an Adverse Event (AE) associated with a veterinary clinical trial.
    • Discuss how to determine the severity of an AE as well as its potential attribution.
    • Identify common categories used to determine the relationship between the AE and various attributions.
  • Module 6. Data: Case Report Form (CRF) and Common Pitfalls
    • Describe what a case report form (CRF) is and how it is used.
    • Discuss how to manage the quality of CRF record keeping during the data collection and analysis cycle.
    • Identify best practices for recording, updating, and maintaining CRF data.
  • Module 7. Data: Documenting Adverse Events (AE)
    • Explain when, where, and what Adverse Events (AE) should be recorded.
    • Compare AE with Serious Adverse Event (SAE) and differentiate action steps required.
    • Determine other unanticipated problem(s) and reportable event(s) that need to be documented.
  • Module 8. Data Quality Assurance/Control and Final Report
    • Compare and contrast quality assurance (QA) and quality control (QI).
    • Describe the role and expectation of monitors in both QA and QI.
    • Discuss final reporting and archiving steps in closing out a completed study.

Resources

  • Lecture Slide Deck (PDF)

Course Evaluation

  • Post-Course Evaluation
  • Course Completion Verification
 This Course is Free