Guide for Veterinary Clinical Research

Documentation Requirements: 

PIs interested in proceeding with a clinical trial need to consider the following:

1. Sponsored Programs Proposal Notification: To be completed by faculty or department/college grant administrators, not a Special Program Officer (SPO). The notification form can be found here. 

   Proposal Submission Timeline: The timeline requirement provides internal deadlines by which notification must be made and proposal components provided to Sponsored Programs to allow staff to complete their review before submission to the sponsor.

   General Requirements: All proposals for externally funded awards, grants, or contracts must follow timeline requirements and be routed for institutional review/approval through the Office of Sponsored Programs (OSP).

   • Mandatory Notification: The Sponsored Programs Proposal Intake Form must be completed except for units with existing intake systems (COM GMO, CCC, Engineering, CFAES).
   • Deadlines will be Enforced: Proposals not meeting these deadlines will not be submitted.
     • Notification for standard proposals at least 2 weeks prior to the proposal due date.
     • Final budget documents available for SPO approval 4 business days prior to the due date.
     • Proposal must be ready for SPO review and submission 2 business days prior to the due date. No submissions after 5 pm or on weekends, regardless of agency deadlines.
     • Other dates as outlined in the full guidance.
     • Exceptions will be on a case-by-case basis and granted sparingly at OSP discretion.

   Standard vs. Complex Proposals: Two sets of timelines depending on the type of proposal. 

   • Standard Proposals: Proposals not meeting below complex proposal criteria are considered standard.
   • Complex Proposals: Have an annual budget of $1 million+ or a total budget of $5 million+; and/or subawardees, community partners, companies, or other organizations with Ohio State as lead.

2. Qualification of Sponsor: 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 for qualifying 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 flow:

• 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.
• Materials 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 request processes. The Technology Commercialization Office is the Point of contact for CDA and material transfer agreement 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 the Office of Research Compliance on an annual basis. A best practice is to ensure your COI submission is current before moving into the 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's expertise and commitment to support the proposed clinical research (if the PI was not the original contact).

Key Points

•  The scope of work must be defined and finalized before developing the budget.
• The source of funding for the clinical research must be defined before budget development.

Budget Development

3. Research Rates: Discounted fees for services at the VMC apply ONLY to not-for-profit foundations, other university trials, OSU intramural funds, and development funds. Industry sponsors are for-profit entities and do not receive research rates. 

   In general, a 20% discount (based on client pricing) will be applied to all VMC charge codes. Discounts on pharmacy items are determined by the pharmacy staff and VMC. 

4. Fiscal Increases: Trials could span multiple fiscal years. OSU and VMC prices could increase 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.
5. Release Time (% effort): PIs should work with a Senior Grants and Contracts Specialist, currently Jeff Workman, for calculating release time, and the cost should be factored as per year cost for the duration of the trial. As with all certifications of personnel effort on sponsored projects, the PIs will receive an email alerting them to review and, if correct, certify the effort appointed to the project. 

Key Points

• If any Investigator is receiving release time/percent effort on a trial, this must be evaluated annually to assess whether the release allocation is appropriate.
• It is the PI's responsibility to manage release time/percent effort and conflict of interest updates.

6. Gift Card Incentives: In limited instances, the use of gift cards may be appropriate for patient participation, particularly for survey-only research trials. The use of gift cards must be approved as part of the trial proposal when reviewed by the Office of Research and Graduate Trials. PIs are responsible for following the Policy on Payment to Research Subjects and CVM Guidelines when using gift cards.
   • Gift cards CAN BE BOUGHT from startups or release time funds with PRIOR fiscal approval.
   • BBVCTO gift card management service only applies to gift cards given to the recipient in person or e-gifts.
     • CVM gift card SOP and documents
     • Offices of Sponsored Programs

7. Multi-Center Trials: Clinical trials that involve one or more external institutions to which The Ohio State PI is providing oversight.

   There are additional budget considerations to be made when anticipating a multi-center trial. A signed Sub-recipient Letter of Intent, Appendix A, will need to be received from all participating sites before finalizing the budget.

   If third-party materials are anticipated for a multi-center trial, MTA aspects will need to be addressed prior to the initiation of the trial. The PI will need to work with OSP on completing and ensuring subcontracts are in place prior to initiation of enrollment at the site. 

8. 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, Appendix B.

   PIs can submit a request for budget development guidance from the BBVCTO through the Clinical Trial Service Portal.

BBVCTO and VBR Services:

9. Clinical Trial Assistance from the Blue Buffalo Veterinary Clinical Trials Office (BBVCTO):
   • Administrative Support:
     • Clinical research assistance/consults (development, design, review).
     • Budget development/review (research rate assistance).
     • Congruency review for both industry and non-industry clinical trials.
     • Contract assistance/review
   • Clinical Trial Setup: The Clinical Trial Startup phase involves approximately the 3 months leading up to the opening of enrollment for a clinical trial. This is a non-refundable, upfront payment from the sponsor to the clinical trial office to cover administrative tasks. It includes the necessary tasks and communication involved in the preparation for the clinical trial to begin. Tasks can include site preparation/multi-centering, review of trial documents (protocol, SOPs, consent, budget, etc.), account setup assistance, data collection management preparation, operational feasibility, investigational product management, patient recruitment assistance, and more.
     • Level 1: Limited trial involvement. The BBVCTO staff only assists with specific trial activities such has only offering financial management, or only sample process, or only post-trial completion survey data collection, or only data entry.
     • Level 2: Moderate trial involvement. Single-site clinical trial with full support (technical/coordinator).
     • Level 3: Large trial involvement. Outside sponsored trial, or  FDA trial,  or multicentered trial with full support (technical/coordinator).
   • Clinical Trial Support Services:
     • Incentive Management: Provide support for processing, tracking, and documenting financial and non-financial incentives to participants, rDVMs, and possibly additional sites. This includes gift cards (eGift Cards or physical gift cards only), 1099 owner payouts, and products or vouchers provided by the sponsor.
     • Research Coordinator: Provides management of day-to-day trial activities, including ensuring the trial is conducted in accordance with the protocol, regulations, and ethical standards. Acts as the main point of contact for research participants, the trial staff, and/or the sponsor. Responsibilities include assisting with data collection, ensuring safety, maintaining compliance, liaising with additional sites, and managing the trial team.
     • Technical Support: Licensed RVTs that are able to assist with patient care, research-related procedures, owner/patient-related communication, and maintaining the confidentiality of patients and research data.
     • Multicenter Support: Able to aid with the processes of overseeing and coordinating the clinical trial at additional research sites, ensuring consistency in data collection and protocol adherence. Responsibilities included managing logistical complexities, maintaining communication, and ensuring the standardization and completeness of data collected at each site.
     • Clinical Data Management: Creating customized data collection that can include REDCap (Research Electronic Data Capture) or trial subject binders/paper case report forms (CRFs). Custom training, surveys, data reports, and support are available for REDCap projects created by the BBVCTO. Entering and managing trial data in paper CRFs and electronic databases such as Prelude, REDCap, Orical, etc. Our research specialists can quality control (QC) data collected throughout the trial. (Multicenter sites will only be QC'd for completeness by the BBVCTO). Outsourced electronic database build consultation.
     • Research Sample Management: Assist with the collection, processing, storage, shipping, tracking, retrieval, and disposal of biological samples (such as blood, urine, feces, tissue samples, etc.) from clinical trial patients.
   • Clinical Trial Closeout: Performed at the completion of enrollment/participant completion, approximately two months are expected for trial closeout procedures to be completed. Tasks performed include ensuring participant data is complete, finalizing participant interactions,  trial products, equipment and supplies are accounted for and reconciled, final trial specimen/sample handling, final communications, site close out,  data archiving, final data is submitted to sponsors/oversight bodies, finalize finances,  and the trial is formally archived post the required retention period, and more.
     • Level 1: Limited trial involvement -  The BBVCTO staff only assist with specific trial activities, such as only offering financial management, or only sample process, or only post-trial completion survey data collection, or only data entry.
     • Level 2: Moderate trial involvement- Single-site clinical trial with full support (technical/coordinator).
     • Level 3: Large trial involvement- Outside sponsored trial, or  FDA trial,  or multicentered trial with full support (technical/coordinator). 

Services from the BBVCTO can be requested through the Clinical Trial Service Portal.

• Marketing Support: BBVCTO offers a variety of complementary marketing resources to promote clinical trials and ensure timely enrollment of patients. To request marketing services, visit our Clinical Trial Service Portal and select marketing to submit a request. Complementary marketing services include:
  • Internal Marketing (VMC):

    • Current Trial website posting: This is an overview of the Clinical Trial posted on the VMC-BBVCTO website. The details include information regarding participation, what to expect, potential medical benefits and risks, compensation, etc.  The standardized BBVCTO pre-screening survey link and a downloadable PDF file will be included with the posting. 

      • BBVCTO will communicate with potential participant owners/rDVMs ONLY when technical support is provided in the trial budget. If tech support is not requested, the completed pre-screening surveys and other forms of communication will be forwarded to the investigator.

    • Clinical Trial List (Flyer): Circulated at rDVM and CE events, conferences, etc. by the Veterinary Medical Center Practitioner Liaison efforts. 

    • VMC Lobby Monitor: Service-specific Slides: Slides will circulate on the lobby monitors for services with open clinical trials listed on the website. The slides include QR codes that direct interested parties to the "Current Trial" web page and Pre-Screening Survey.

  • AVMA Web Posting: BBVCTO will post the clinical trial on the AVMA website on behalf of the Primary Investigator. The primary contact provided will be used for the AVMA posting. BBVCTO staff will communicate with potential participants ONLY when technical support is provided in the study budget. If tech support is not requested, inquiries will be forwarded to the investigator.

  • College of Veterinary Medicine Media Department Marketing Offerings:

    • Social media: The college will post a rotation of currently active clinical trials that select to use College Marketing Offerings, where space allows in the existing content calendar, up to three times throughout your trial. Please allow five business days to begin seeing your trial populate.

    • The Marketing and Communications Specialist, Sarah Kroger (kroger.45@osu.edu), is the primary contact for the Veterinary College social media efforts. 

      All marketing is to be requested via the BBVCTO Service Portal

Key Points

• It is strongly suggested that an initial meeting be scheduled with the BBVCTO when considering conducting a clinical trial at the CVM, or when BBVCTO services are requested. Keeping BBVCTO involved in industry sponsor discussions will ensure immediate support for trials.

10. Veterinary Biospecimen Repository (VBR) Services: The VBR represents a remarkable resource for investigators to develop new prevention and treatment strategies for both animals and people with a variety of illnesses. 

    • Collection and Processing: 

      • Sample Collection: All samples are collected from client-owned animals after obtaining informed consent from owners. Urine and blood are collected prior to surgery or euthanasia. Tissue samples are collected from tissue that is removed during surgery or immediately following euthanasia. All samples are processed immediately following collection. Samples are stored under controlled conditions for future use. 

      • Requesting Services: Services can be requested via eRamp.

Approvals

CVM Budget Congruency Review

11. PIs conducting research involving privately-owned animals are required by the CVM to have the associated study trial budget reviewed and approved undergo a congruency review performed by the BBVCTO. The budget congruency review must happen before a PI self-funded study trial or a proposal is submitted to the sponsor or funding agency, and before a contract is signed with an industry sponsor.

    This is to ensure that budgets are formulated in accordance with hospital fees, research discounts, and other college requirements and are congruent with both the study trial protocol and study calendar. It is strongly recommended that PIs reach out to the BBVCTO staff early in the process of study trial design to avoid delays during the congruency review. Budgets funded by internal sources should be submitted before initiating the IACUC review process.

    PIs can request a Budget Congruency Review by submitting the following information: 

• Grant

• Calendar of Events

• Protocol and Consent Form

• Budget (A draft is acceptable; refer to our Budget Builder Template).

Templates are available for download on the BBVCTO Investigator Page

As part of the congruency review process, the BBVCTO staff reviews the budget to ensure it is congruent with the grant proposal, consent form, and calendar of events/trial protocol. The staff may provide comments and request additional information for clarification.

An approval letter will be sent once the congruency review is complete. The approved budget can then be submitted to the sponsor.

Key Points

• New clinical trials are required to submit the budget for a Congruency Review. PIs are asked to allow for a minimum of 10 business days before a grant submission deadline, finalizing a PI self-funded trial (start-up or development funds), or submitting to an industry/sponsor for the BBVCTO to process the review adequately. 

• Failure to submit for a Congruency Review by the requested time frame will result in delayed grant submission, commencement of a self-funded trial, or the accuracy of the review to be performed in the shortened time allowed. For privately sponsored trials (i.e., industry, etc.), this may also result in a significant delay in trial initiation while questions or discrepancies are resolved.

• Ongoing trials that undergo protocol changes/amendments, or the budget has been altered, are encouraged to undergo a new Congruency Review and have the new approved budget resubmitted to the sponsor for approval. Trial Agreements will also be required to be amended with the new budget. 

Institutional Animal Care and Use Committee (IACUC)

12. The IACUC oversees the responsible use of animals in university research and instructional activities. It reviews protocols, the animal care and use program, and monitors university animal facilities to ensure compliance with standards and regulatory requirements. Trials using privately-owned animals are considered clinical research. All clinical research conducted at The Ohio State University CVM currently requires approval from the IACUC Subcommittee through the submission of an Animal Use Protocol.
    • Submitting an Animal Use Protocol to IACUC: PIs can visit the Office of Responsible Research Practice to access e-protocol, the online submission portal, and investigator guidance.
    • Trial Team Requirements: For individuals to be listed on an Animal Use Protocol, they must be provided an account in e-Protocol by completing the e-Protocol registration. Individuals who have not registered will not have access to e-Protocol and will not be available for selection as a trial team member in the system.

      • Training Requirements: Before conducting research, all trial team members who handle and/or perform procedures on clinical trial patients must be added to the respective IACUC, and all members are required to complete specific training and courses, including:

        • Animal Use Orientation and Occupational Health and Safety Training
        • Working with IACUC
        • Occupational Health Program
        • Responsible Conduct of Research (RCR)
        • Conflict of Interest (COI) Screening/Disclosure
        • Experience and training Narrative

        Visit the Office of Responsible Research Practice for information about training requirements for investigators and trial team members who are listed on an animal use protocol. 

    • Good Clinical Practice (GCP): GCP training includes a set of guidelines that must be followed when conducting clinical trials to ensure that the rights and well-being of the trial participants are protected, and that the data generated in the trial is valid.

• VMC-IACUC Privately Owned Animals Subcommittee: IACUC protocols and amendments that involve activities using privately owned animals are routed to the Privately Owned Animals Subcommittee for review and approval. This mechanism will be triggered when a PI from the CVM enters “privately-owned” as an animal source in the protocol.

  PIs are required to upload a copy of the informed consent under the timeline section and a copy of the study trial plan (grant or other complete study trial design documents) in e-Protocol as part of the IACUC submission. Failure to include both of these documents will result in a delay of the review process.

  • Healthy Pets in Clinical Trials: Research involving healthy animals at the VMC requires special consideration and may necessitate additional approval processes. Please see Appendix C for specific details regarding trials involving healthy, privately owned animals.
• Informed Consent Form Template: The Veterinary Medical Center, the CVM Office of Research, and the IACUC require an approved template that covers pertinent aspects of informed consent for trials using privately owned animals. Approved templates can be found on the Investigator Support page.

• Amending Approved Animal Use Protocols: Changes in patient numbers and/or study trial design require the generation of an amendment and must be approved by IACUC before implementation. Examples of amendments include revisions to consent documents, changes in PI, addition or change in study trial team, increase in patient numbers, change in medications or dosages, and inclusion of additional risks or procedures.

  ---

  Key Point

• Failure to submit an IACUC amendment for a Trial in which elements have been changed or patient numbers have increased may result in termination of the trial. 

Contract Negotiations

13. The Office of Sponsored Programs (OSP) will work with the sponsor to put into place a Clinical Trial Agreement (CTA) with the appropriate terms and conditions for the clinical trial/research.

    Materials may be supplied from the sponsor or a third party for the clinical trial. Most material requirements can be handled within the clinical trial agreement; however, some trials may require a separate material transfer agreement (MTA).

    MTAs govern the terms under which materials can move into and out of the Ohio State Corporate of Engagement Office. They cover the permitted uses, the length of time the materials can be used, and the specifics of the transferred materials.

• Key Point
• While contract negotiations are typically associated with industry-sponsored contracts, agreements received from non-industry sponsors often require negotiations before acceptance by the University.

14. EPA-005: This 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 before proposal submission or contract execution. An EPA-005 is required only for extramural submissions.

15. Contract Execution: Study Trial account numbers are provided by OSP to the PI shortly after the full execution of the contract or notice of award. PIs who are recipients of intramural awards will be notified by Michele Morscher in the CVM Office of Research. MTA terms can also be included in the clinical trial agreement. In many cases, the sponsor may also seek to use their template. If so, attach that to the MTA request you submit for Post-Contract Execution.

Pre-Initiation

CVM IACUC Trial Registration and Reporting

16. Trial Registration: Once the email/approval letter from IACUC is sent out, a staff member from the BBVCTO will send the registration link via email (within a two-week window) to register your clinical trial in the Approved IACUC Registration Database. This MUST be completed before the study can be initiated.

    Registration will include: a primary contact, anticipated start and end date of enrollment, anticipated number to be enrolled, financial data, total budget amount, and additional data points used for metrics. 

    The PI will receive an email notification from the BBVCTO indicating the trial registration is complete once the registration has been submitted. It is required that clinical trials be registered before the trial is initiated.

    Quarterly Enrollment Reporting: The PI will receive an automatic email every 3 months from the reported trial start date for investigators to report the status of the trial and patient enrollment. Accurate information regarding enrollment numbers in clinical research studies is required by the CVM, CCC, and CCTSI. 

17. For trials not