College of Veterinary Medicine Clinical Research Guide

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): 
  • Michael Adkins, CRA, Sponsored Programs Associate Manager; adkins.121@osu.edu  
     
• 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:

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):

• CVM Office of Research:
  Ivana Cieslewicz; Education Program Senior Specialist
  Cieslewicz.6@osu.edu  

Intramural Sponsored Clinical Trial Workflow 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: 

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

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. 

• To submit the request for BBVCTO services, the PI is to submit a Request in the BBVCTO Service Portal, https://redcap.link/BBVCTOPortal.  

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. 

Researchers planning to submit a proposal for external funding must alert the sponsored program team of their intent via a new Sponsored Programs Proposal Intake Form at least two weeks prior to the proposal due date.  

• This does not replace the Authorization to Seek Off-Campus Funds (ePA-005).

The Enterprise for Research, Innovation and Knowledge has implemented a formal Sponsored Programs proposal submission timeline requirement. The deadlines vary depending on whether a proposal is classified as complex or standard.
All proposals for externally funded awards, grants, or contracts must follow these timeline requirements and be routed for institutional review/approval through the Office of Sponsored Programs (OSP).

• Detailed information regarding these timelines can be found on the Sponsored Programs Proposal Submission Timeline Requirements page.

The ePA-005 is the university’s proposal pre-approval application used by investigators submitting proposals to external sponsors. A fully signed ePA-005 must be available to the Office of Sponsored Programs prior to proposal submission or contract execution.

• An ePA-005 is only required for extramural submissions.

Prior to finalizing the budget and trial initiation, the PI should identify and consult with any additional VMC clinical services needed to perform trial-specific procedures outside of the PI’s primary service. The PI should confirm service availability, procedural requirements, scheduling, costs, documentation expectations, and other trial-specific needs. Appropriate personnel should be provided with the information necessary to perform protocol-required activities. Consultation should occur early enough to identify and resolve potential operational concerns before patient enrollment and trial activities begin.

Radiology Services: Clinical trials Radiology services need to be discussed with Radiology during trial development and prior to patient enrollment. The PI should provide the applicable trial protocol and imaging requirements to the designated Radiology contacts for review. Radiology will assist with determining appropriate imaging costs and, when trial-specific imaging differs from routine clinical procedures, develop an imaging protocol to ensure consistent performance of required imaging. Early coordination helps prevent unexpected imaging requirements, inappropriate charges, scheduling concerns, and potential protocol deviations.

• Radiology Contacts (2026):
  Dr. Eric Green, green.689@osu.edu
  Denise Baily, bailey.885@osu.edu 

• Research Rates: ONLY not-for-profit foundations, other university trials, OSU intramural funds and development funds are eligible to utilize research rates. Industry sponsors are for-profit entities and do not receive research rates. 
  Effective Tuesday, July 1st, 2025, the university requires the use of research charges that have been fully costed. Allowable research codes and costs can be found listed on the Customer Fee Lists page.
• Pharmacy Research Rates: Information regarding pharmacy research services can be found at, https://go.osu.edu/researchpricing.    
  • Ordering Research Medications: Client and research pricing is available in the Shared Drive at V:\Interdepartmental\Public\Pharmacy Price List\. The excel spreadsheet is updated daily.
  • Ordering: The pharmacy is listed in Workday as a supplier under Veterinary Med Center - Pharmacy. The price sheet (Excel spreadsheet) can be used as the Quote for submitting the Workday request.
  • Additional Research Services: The OSU VMC Pharmacy can assist with additional aspects of veterinary research. There is a one-time fee of $256 for clinical research services; more extensive services are subject to additional fees. The pharmacy can provide various services such as; medication storage, dispensing, blinding, compounding, and more.
• Fiscal Increases: Trials typically span multiple fiscal years. OSU and VMC prices are likely to increase one to two times each fiscal year (FY start is July 1). PIs should work with the BBVCTO to determine how best to accommodate potential price changes during the course of the trial.

• Release Time (% Effort): PIs should work with the Sr. Grants & Contracts Specialist, to calculate release time, and the cost should be factored as a per-year cost for the duration of the trial.

  Current Contact (2026):
  Jeffrey Workman
  Sr. Grants & Contracts Specialist
  Workman.45@osu.edu 

  Release-time/% effort on a trial must be evaluated annually to assess if the release allocation is appropriate. 
  It is the PI’s responsibility to manage release-time/percent effort. An email will be received annually alerting to review and certify the effort appointed to the project is correct.

• Facilities and Administrative (F&A) Costs: Also termed overhead or indirect costs. F&A costs are variable depending on the funding source (industry vs. non-profit) and are used to support institutional infrastructure. Reference the CVM F&A Rates document.
• Client Incentives: The OSU-VMC offers miscellaneous payments to process financial incentives for participating in a clinical trial. Account credits are no longer permitted and gift cards are strongly discouraged.
  Incentive payments are provided as a check or direct deposit. The client will be required to complete a Payee Setup Process, to be added in the CVM payment system. More detailed information can be found on the Investigator Support page, under Incentive Payment Processing Steps.
• Screen Fails/Adverse Events/Unscheduled Visits: Trials that plan on covering costs for patients that fail screening for enrollment, paying for adverse events, or performing trial required procedures and/or collection data for off schedule visits need to account for the additional cost for these events. The costs should be calculated to include any charges that would be accrued in addition to the estimated time for BBVCTO support (if utilized).
• Consumables/Supplies/Shipping: Consider all consumables, supplies, and shipping expenses required throughout the study. This may include sample collection supplies, laboratory materials, packaging, dry ice or other temperature-control materials, courier fees, and overnight shipping. Estimate these costs based on anticipated enrollment and study activities and include an appropriate allowance for variable or unexpected expenses.
• Multi-Centered: Clinical trials involving external institutions or sites under the oversight of the OSU PI require additional budget and agreement considerations. A signed Subrecipient Letter of Intent must be obtained from each participating site before the budget is finalized. The PI should work with OSP to ensure required subcontracts are in place before enrollment begins at each site. If third-party materials will be used, any required Material Transfer Agreements (MTAs) should also be completed before trial initiation.
• Cost of BBVCTO Services (optional): To submit a request for BBVCTO services and have the costs added to the trials quote or budget, submit a Request in the BBVCTO Service Portal, https://redcap.link/BBVCTOPortal.  

All clinical research involving privately owned animals at the OSU-VMC requires a Budget Congruency Review by the BBVCTO. The review ensures the trial budget aligns with the protocol and study calendar and includes appropriate VMC fees, research pricing, and other CVM requirements. PIs are encouraged to work with BBVCTO during budget development to improve accuracy.
Budget Congruency Review requests must be submitted through the BBVCTO Service Portal, https://redcap.link/BBVCTOPortal, at least 10 business days before the submission deadline and before a funding proposal is submitted, an industry-sponsored agreement is signed, or a self-funded trial opens.

The following documents are required to complete a Budget Congruency Review:

• Completed Grant Application
• Trial Calendar of Events
• Trial Protocol and Consent Form
• Budget

The link to templates for protocols/SOPs, calendar of events, IACUC approved consent form, budgets, etc. can be found on the Investigator Support page, Clinical Research Templates.

While contract negotiations are typically associated with industry-sponsored contracts, agreements received from non-industry sponsors often require negotiations prior to acceptance by the University. The Office of Sponsored Programs (OSP) works with the sponsor to establish a Clinical Trial Agreement (CTA) with appropriate terms and conditions. Study materials provided by the sponsor or a third party are generally addressed within the CTA; however, a separate Material Transfer Agreement (MTA) may be required. An MTA defines how transferred materials may be received, used, stored, and transferred during the study.

The Office of Sponsored Programs (OSP) accepts sponsor funds on behalf of the university and the PI. Until OSP completes the necessary administrative tasks (negotiating award terms, establishing the project account, and returning signed agreement to the sponsor if necessary), the award is not legally accepted, and costs may not be incurred.

• If a PI is notified by a sponsor of an award, the agreements and any other documentation should be sent to the sponsored program officer.

All documents requiring an official signature must be signed by an authorized representative of the OSP. PIs are not authorized to sign agreements on behalf of the university.

A preliminary grant number allows project spending to begin before all award paperwork is finalized. It may be useful when early spending is needed for equipment, staffing, transferred awards, subawards, or projects awaiting agreement completion. Sponsor approval may be required for pre-award costs. The PI’s department is responsible for costs incurred if the award is not received or the expenses are not approved.

• Preliminary grant numbers are assigned after OSP receives a completed Authorization for Expenditures/Commitments in Excess of Funds Available (OGC-005) form.

Visit the Animal Care and Use page to access e-Protocol, the online submission portal and investigator guidance.

IACUC protocols and amendments that include activities using privately-owned animals are routed to the Privately-Owned Animals Subcommittee for review and approval. This mechanism is triggered when a PI from the CVM enters privately- owned as an animal source in a protocol.
A copy of the informed consent form is required to be uploaded under the timeline section and a copy of the study trial plan (grant, protocol, additional trial design documents) as part of the IACUC submission. Failure to include these documents will result in a delay in the review process.

The Veterinary Medical Center, the CVM Office of Research and the IACUC require an approved template that covers pertinent aspects of informed consent for studies trials using privately-owned animals. The link to the approved consent form template can be found on the Investigator Support page, Clinical Research Templates.

For individuals to be listed on an Animal Use Protocol they must obtain an account in e-Protocol by completing the e-Protocol registration. Individuals who have not registered will not have access to e-Protocol and are not available for selection as a trial team member in the system.
Prior to starting research activities for a trial, all trial team members performing patient handling, procedures, sample collections, etc. are required to be added to the respective IACUC. Trial team members are required to complete specific training and courses to be eligible to perform assigned trial activities. Training requirements information can be found on the Animal Study Team Requirements page.

• Occupational Health Program; Online Risk Assessment Tool (ORAT)
• Animal Usage Orientation and Occupational Health and Safety Training
• Responsible Conduct of Research (RCR) 
• Conflict of Interest (COI) Disclosure
• Experience and Training Narrative
• CITI – Working with the IACUC
• Good Clinical Practice (GCP)

Healthy privately owned animals may be enrolled in clinical trials as controls, normal subjects, or donors of normal biological samples such as blood, urine, other fluids, or tissue.

• Healthy privately owned animals: Any privately-owned animal not owned by the University, (this includes animals owned by faculty, staff and students), coming to the VMC solely to participate as a “control” or “normal animal” in a clinical trial or to donate “normal” fluid (blood, urine, etc.) or tissue for use in a research project. These animals are classified as not having a disease process that requires treatment during their visit and are presented to the VMC only to participate in research at the request of an investigator.

When enrolling healthy privately owned animals:

• IACUC Approval and Consent: The trial must have appropriate IACUC approval, and the owner must sign the clinical trial consent form before participation.
• Trial Documentation: The investigator is responsible for maintaining required trial documentation, including signed consent forms, within EMR and trial patient database.
• Scheduling: Animals are to be scheduled with managing clinical service. Research visits should use a research appointment rather than a routine clinical appointment slot.
• Medical Record: A medical record accession is to be created for each visit to the VMC.
• Physical Examination and Charges: A physical examination is to be performed and documented in the medical record, with the appropriate examination charge entered in ezyVet. 
  • Faculty, staff, and student-owned animals receive the applicable employee examination fee.
  • Other privately owned animals receive the standard examination or recheck fee charged by the service.
• Housing: Animals should be housed in the appropriate clinical service ward when housing is required.
• Discharge Documentation: A patient summary must be completed on ezyVet for each visit. At minimum, it should document: 
  • Clinical trial name
  • PI/Investigator
  • Brief description of the research activities performed during the visit

Changes to an approved clinical trial IACUC, such as patient enrollment numbers, consent forms, study design, sample collection, medications, dosages, procedures, PI, or trial team members, require an IACUC amendment. Amendments must be submitted to and approved by IACUC before the proposed changes are implemented.

• Failure to submit and obtain approval for an IACUC amendment before initiating amended trial activities may result in suspension or termination of the clinical trial.

Trial Account numbers are provided by OSP to the PI shortly after the full execution of the contract or notice of award. MTA terms can be included in the clinical trial agreement. In many cases, the sponsor may also seek to use their template. If so, it can be attached to the MTA request that Post-Contract Execution is submitted.

• PIs who are recipients of intramural awards will be notified by the Education Program Senior Specialist, in the CVM Office of Research.

  Current Contact (2026):
  Ivana Cieslewicz
  Cieslewicz.6@osu.edu 

For trials not using BBVCTO financial services, the PI must provide VMC Accounting with the final trial budget and trial account number(s). VMC Accounting will use this information to provide prepopulated write-off forms that are required to be used during the trial. Refer to the Accounting Write-Off SOP on CVM-Community for additional guidance.

When requesting BBVCTO services, such as technical support, REDCap, or financial management, the PI must sign a financial services agreement. The agreement authorizes BBVCTO to manage approved trial-related financial activities, including reviewing accounts, submitting write-offs, Workday requests, and preparing and submitting invoices in accordance with the approved trial budget and research agreement.

Prior to initiating a clinical trial, the PI is responsible for ensuring that the clinical trial protocol and applicable study-specific SOPs are finalized, reviewed, and approved, as required. These documents should clearly describe trial procedures, patient management, data collection, safety reporting, and trial team responsibilities. 
The PI should ensure that study personnel have access to the current approved documents and understand applicable procedures before beginning trial activities. Subsequent changes must be documented and submitted for required approval before implementation.

Prior to opening a clinical trial for enrollment, the PI is responsible for ensuring that all applicable regulatory, administrative, financial, and operational start-up requirements have been completed. This includes finalizing the protocol and study-specific procedures, obtaining required approvals, establishing the trial budget and accounts, coordinating with participating clinical services, confirming availability of necessary resources, and preparing the trial team. The PI should ensure that trial personnel understand their assigned responsibilities and have access to current approved trial documents. Recruitment, enrollment, and protocol-specific activities should not begin until the trial is fully approved and operationally ready to proceed.

• If BBVCTO services are utilized, BBVCTO staff will assist with clinical trial start-up activities within the scope of the services requested and agreed upon for the trial. The PI is responsible for collaborating with BBVCTO staff and providing the information necessary to complete these activities.

VM Clinical Trial Registration is required for new IACUC protocols and amendments that add a new clinical trial to an existing IACUC protocol. Registration allows the College to track clinical trial activity and patient accrual for required annual reporting. Following IACUC approval, the PI will receive an email from BBVCTO with a unique link to complete the required registration.

• Metrics & Reporting: A survey will be sent to PIs every 3 months to capture specific trial information (i.e. enrollment status, number of patients, etc.). 
• IACUC Reporting: PIs are required to report number of animals used for each IACUC protocol in eProtocol. 
  • Reference: Documenting Number of Animals for Research & Teaching.

Site monitor sponsor visits are typically scheduled throughout the duration of a clinical trial that is sponsored by external funds. During the initiation visit the sponsor usually provides the study trial materials and training. Periodic monitoring visits can occur throughout the course of the clinical trial, and a closeout visit can occur when the clinical trial has been completed at a site.

• If the PI requested support from BBVCTO, the individual(s) assigned to the clinical trial will prepare for all sponsor visits.

PIs are to inform their service and department chair of their trial by providing an on-boarding meeting. Information to be provided:

• Trial overview
• Inclusion/exclusion
• Staff Trial involved/contact information
• Trial calendar
• Where to find the trial protocol, consent forms, etc.
• PI Leave Designation Plan

Leave Designation Plan:

It is recognized that there may be times when the PI is not available due to travel, Illness, and additional commitments. The PI is responsible for putting a plan in place to manage enrollment and continued treatment of study trial patients during planned and unplanned absences. It is recommended to follow and utilize the PI Leave Designation Plan Record. 

During the clinical trial, the PI and study team are responsible for completing required reports and maintaining appropriate safety reporting documentation in accordance with the trial protocol, applicable agreements, sponsor requirements, and institutional requirements. Reporting may include mid-trial progress, enrollment, protocol deviations, adverse events, safety concerns, and other trial-related updates. Reports should be completed and submitted at the required time points.

Protocol Deviations:

A protocol deviation is a planned or unplanned departure from the approved clinical trial protocol, procedures, or requirements. Examples include missed or delayed visits, procedures completed outside the required timeframe, enrollment that does not meet eligibility criteria, missed procedures, or incorrect administration of trial treatment. Deviations should be documented, evaluated for their impact on patient safety and data integrity, and reported according to the protocol, sponsor, agreement, and institutional requirements.

• BBVCTO offers a standardized Deviation Report Form. The Word document can be found on the Investigator Support page, https://go.osu.edu/cvminvestigatorsupport.   

Note to File (NTF):

Documentation is used to clarify or explain a trial-related issue, discrepancy, or circumstance that is not adequately documented elsewhere. The NTF should describe the issue, its impact on trial subject safety or data integrity, and any corrective actions taken, when applicable.

• BBVCTO offers a standardized NTF Report Form. The Word document can be found on the Investigator Support page, https://go.osu.edu/cvminvestigatorsupport.   

Concomitant Treatments (Con Meds):

Concomitant medications (Con Meds) are medications, supplements, therapies, or other treatments a patient receives in addition to the test article being evaluated during a clinical trial. Con Meds should be documented as required by the protocol and evaluated for potential effects on patient safety, trial treatment, or trial results. The protocol should be reviewed to determine which medications or treatments are permitted, restricted, or prohibited.

• BBVCTO offers a standardized Con Med Report Form. The Word document can be found on the Investigator Support page, https://go.osu.edu/cvminvestigatorsupport. 

Adverse Events (AE) and Serious Adverse Events (SAE):

Adverse Events (AEs): An unexpected medical problem that occurs in a patient during a clinical trial. AEs may range from mild to severe and may or may not be related to the test article, treatments, or procedures.

Serious Adverse Events (SAEs): SAEs are required to be reported to the VMC-IACUC in eProtocol. SAEs are AEs that meet one or more of the following criteria:

• Grade 3 or higher per VCOG- CTCAE;
• Results in death;
• Is life-threatening;
• Requires or prolongs hospitalization;
• Results in persistent or significant disability or incapacity; or 
• In the investigator’s judgment, represents a significant hazard or potential for serious harm to a trial subject.

Standardized Adverse Event Grading System:

The Veterinary Cooperative Oncology Group–Common Terminology Criteria for Adverse Events (VCOG-CTCAE v2) guidelines are used to classify and grade AEs and SAEs. This version replaces the previous VCOG criteria and includes expanded categories for neurologic, cardiac, immunologic, and procedure-specific adverse events, allowing for more comprehensive and consistent AE assessment across veterinary clinical trials.

• It is strongly recommended to use VCOG-CTCAE v2 for all clinical trials for reporting and grading AEs and SAEs.) BBVCTO offers standardized AE and SAE Report Forms. The link to obtain the Word document can be found on the Investigator Support page: https://go.osu.edu/cvminvestigatorsupport. 

Trial Withdrawal/End of Trial:

Documents when a trial subject completes or withdraws from a clinical trial, including the date, reason participation ended, and required follow-up, if required. The completed form should be maintained with the applicable trial records.

• BBVCTO offers standardized Trial Withdrawal/End of Trial Report Form. The Word document can be found on the Investigator Support page: https://go.osu.edu/cvminvestigatorsupport.