College of Veterinary Medicine Clinical Research Guide

The College of Veterinary Medicine Clinical Research Guide (CVM-CRG) outlines the processes, procedures, and resources for conducting clinical research involving privately owned animals at The Ohio State University College of Veterinary Medicine (OSU-CVM).


All research involving privately owned animals must follow guidelines established by The OSU-CVM, The OSU Office of Responsible Research Practices, and the U.S. Department of Agriculture (USDA).


Principal Investigators (PIs) are to follow the policies and procedures in the CVM-CRG to maintain research integrity and meet regulatory requirements.
 

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Funding Types and Processes

The CVM requires PIs to follow established processes when initiating and conducting clinical research involving privately owned animals. Requirements vary based on the funding source. PIs should review the appropriate funding-specific requirements prior to selecting funding.


Before You Begin: Identify your project's sponsor/funding source. Review the corresponding workflow charts to the funding listed, to ensure all applicable requirements and processes are followed. Sponsors/funding sources include: 

  • Industry: Corporate or Industry, including small and large companies. 
  • Intramural: Internal funding sources include C. Glenn Barber Funds, CVM grants (Canine, Feline, Equine, and Palatin), Mark L. Morris Grant, USDA Animal Health Formula Funds, Pelotonia, development funds, and startup funds. 
  • Non-Industry: Non-profit organizations, foundations, government (federal agencies, state agencies and, local government entities), and other sponsors that are not commercial/for-profit organizations. 

Clinical trials financially supported by a commercial company, such as a pharmaceutical, biotechnology, medical device, or animal health company. The industry sponsor typically provides funding and may provide trial protocol, investigational products, equipment, or other trial materials. The PI is responsible for conducting the trial according to the approved protocol, applicable agreements, institutional requirements, and regulatory standards.
 

OSU Contacts for Industry:
Current Contacts (2026); Industry and For-Profit Funding/Sponsors:

  • Office for Business and Industry Contracts (OBIC): 
  • CVM Office of Research & Graduate Studies – Grant Support Office:
    • Jeffery Workman, PhD; Dr. Grants & Contracts Specialist; workman.45@osu.edu 
    • Jean Schelhorn, PhD; Director of Commercialization, Director of Industry Collaborations; Schellhorn.1@osu.edu  
       
Industry Sponsored Clinical Trial Workflow Chart:
Industry Sponsored Clinical Trial Workflow Chart.

Abbreviations: DoC: Director of Commercialization; OSP: Office of Sponsored Programs; ROM: Rough Order of Magnitude; SPO: Sponsored Program Officers 

The CVM intramural funding mechanisms provide funding to college faculty and their mentored trainees to conduct clinical trials. Internal intramural funding sources include C. Glenn Barber Funds, CVM grants (Canine, Feline, Equine, and Palatin), Mark L. Morris Grant, USDA Animal Health Formula Funds, Pelotonia, development funds, and startup funds. Grant notices and yearly deadlines are listed on the Intramural Grant Application Information webpage, look under “Section” for additional details.


Questions regarding CVM Intramural Grants 
Current Contact (2026):
Intramural Sponsored Clinical Trial Workflow Chart:
Intramural Sponsored Clinical Trial Work Flow Chart

*No, to BBVCTO; ^Yes, to BBVCTO                                                                                                                                   Abbreviations: OSP: Office of Sponsored Programs

Foundations:


Typical nonprofit sponsors are private foundations, such as the Morris Animal Foundation (MAF), American Kennel Club (AKC), Winn Feline Foundation, and other nonprofit organizations. Refer to the Extramural Funding Sources webpage.


Government/Federal Programs:


Typically, federal agencies sponsor projects of national or universal significance. Federal funding includes the National Institutes of Health (NIH), USDA, FDA, DOD and other governmental funding organizations. Refer to the Extramural Funding Sources webpage. 


Office of Sponsored Programs (OSP) Contacts:
Current Contacts (2026); Federal and Nonprofit Sponsor Funding:

  • Pre-Award: Michael Gallaugher, CRA, Senior Sponsored Program Officer Health Sciences Office; gallaugher.7@osu.edu 
  •  Post-Award: Aimee Sanford, CRA, Senior Sponsored Program Officer; Sanford.136@osu.edu 
Non-Industry Sponsored Clinical Trial Workflow Chart: 
Non-Industry Sponsored Clinical Trial Workflow Chart

*No, to BBVCTO; ^Yes, to BBVCTO                                                                                                                                   Abbreviations: OSP: Office of Sponsored Programs

Requirements Specific to Industry & For-Profit

PIs interested in proceeding with Industry-Sponsored Research for a clinical trial need to review the specific requirements for industry/for-profit sponsors: 

For industry sponsored clinical trials, the College of Veterinary Medicine (CVM) Grant Support Office, and the Technology Commercialization Office (TCO) will qualify the sponsor and determine the clinical trial needs.
PIs should contact the Grant Support Office to qualify a sponsor and initial agreement topics. If there are no intellectual property considerations to industry sponsored clinical research, the Grant Support Office will not need to be contacted to qualify the sponsor.


Topics and questions that will inform sponsor qualification follow:

  • Confidential Disclosure Agreements (CDA): A CDA is a legally binding agreement that allows parties to have confidential discussions. To request an agreement or to learn more about other uses of a CDA visit the Corporate Engagement Office.
  • Material Transfer Agreements (MTA): The college’s Office of Research has resources that can help PIs define what types of agreements may be required and help initiate or guide the agreement’s request processes. The Technology Commercialization Office (TCO) is the point of contact for CDA and material transfer agreement (MTA) request submissions and provides the signatory on behalf of OSU for various agreements.
  • Conflict of Interest (COI): All faculty are required to self-report COI information to Office of Research Compliance on an annual basis. The best practice is to ensure your COI submission is current before moving into steps to develop a clinical trial. The OSU database will be checked as a final step in setting up the agreements for a given clinical trial.
  • Funding allocation and timeline expectations.
  • Clinical caseload to support the proposed trial.
  • PI team expertise and commitment to support the proposed clinical research (if the PI was not the original contact).

Once communication with an industry sponsor has been initiated, the PI is to contact the CVM Director of Commercialization.


Current Contact (2026):

  • Director of Commercialization, Director of Industry Collaborations:
    Jean Shelhorn, PhD 
    Schelhorn.1@osu.edu 

The Director of Commercialization will assist with sponsor communications related to negotiations, ROM submission, and other applicable activities.

  • Important: Do not provide preliminary quotes, pricing, or budgets directly to the industry sponsor before the ROM  has been submitted and accepted through the Director of Commercialization. Coordinating pricing through this process helps ensure that financial information is communicated consistently and appropriately and reduces the potential for sponsors to compare or leverage preliminary pricing outside the established process. 


BBVCTO ROM/Quote Development for Industry Sponsored Trials (optional):
It is strongly suggested to include Blue Buffalo Veterinary Clinical Trials Office (BBVCTO) during the initial communications of an industry sponsored clinical trial (the CVM and VMC recommend utilizing services from the BBVCTO for industry sponsored trials). This assists in building accurate budgets and ensures proper support for the clinical trial. 

The sponsor may schedule Site Monitor visits at trial initiation, throughout the study, and at closeout. Initial visits typically include delivery of study materials or test articles and training of the trial team. During the trial, monitoring visits may be conducted to review study documentation, data quality, protocol compliance, and test article accountability. A final closeout visit is typically conducted to resolve outstanding items and confirm that study data, supplies, test articles, and required documentation are appropriately finalized.

  • Trials that receive full support from the BBVCTO, trial staff will prepare and assist for Sponsor/Site Monitor visits.