Investigator Support


CRAC Submission Process


Guidelines for Formulating, Writing and Submitting Clinical Trial Proposals

Clinical Trials Flow Chart

This is a checklist to help you organize and consolidate your study proposal. The goal is to have you consider all aspects of your study before you write the proposal so that you minimize questions raised in the review process.

You are strongly encouraged to contact the CTO (CVM-ClinicalTrials [at] osu [dot] edu) prior to filling out this form if you have not completed a form in the past. You should also consider having the CTO evaluate your form prior to submission to ensure that all required elements are present. Once you have completed the CRAC form, please email to Nicole Stingle at stingle [dot] 5 [at] osu [dot] edu.

If you need help with this process or have questions, please contact the Clinical Trials Coordinator (Nicole Stingle or Tamra Mathie at clinicaltrials [at] cvm [dot] osu [dot] edu). In addition to the CRAC form, most clinical trials performed at the OSU VMC will require Animal Use Protocol approval by the IACUC prior to enrolling patients.

All relevant Forms

A. Title Page

Title pageThe title page is actually a brief synopsis of your proposed study, so you want to include:

  • A concise title, one that briefly explains the object of the investigation. If this is a pilot study, it is important to include this fact in the title.
  • The full names and affiliations of the investigators that will actually be participating in the study.
  • Any Technical Support that may be needed through out the study.
  • The anticipated length of the study (you can say it is anticipated if the real duration is not definitive).
  • The TOTAL budget for the duration mentioned above (this will be detailed in another section).
  • Animal Use Protocol number following IACUC approval

B. Summary of the Proposed Study

NOTE: For studies that have received extramural funding, a copy of the full proposal must be submitted to the Clinical Trials Office prior to initiation of the project.

It is critical that you provide a sound justification for the clinical trial, and describe your goals in a clear, understandable manner. You should be sure to address the following questions/points when describing your study.

  1. The hypothesis, objectives/goals, and number of animals enrolled
  2. The disease/condition to be treated or studied?
  3. How animals and/or humans might benefit from the study?
  4. An estimate of the overall time frame for completion of the study?

C. Detailed Description of Research/Teaching Procedures

This section allows for you to select the appropriate description.

  1. Please define the nature of the study population
  2. Please define the nature of the investigation:
    1. Teaching versus research:
    2. Invasive versus non-invasive:

D. Impact on Hospital Operations

Describe how your study will impact daily operations of the VMC including:

  1. How the study will affect your commitment to assigned clinical service
  2. Whether there will be any additional demads on staff.
  3. How the additional procedures are to be performed, and by whom.
  4. The impact on ward space, access to ancillary serviced, scheduling of cases.

E. Budget

Prior to formulating your budget, it is recommended that you carefully calculate actual costs of all procedures to be covered in the study. A list of current hospital fees is available on MyCVM. Think about EVERYTHING this study will require, from anesthesia to labor to gauze pads. Your budget should be on a per patient, per visit basis. Please be aware of potential increases in fees instituted at the beginning of each fiscal year (July), and be sure to keep in mind chart fees and professional fees when calculating the budget.

  1. All costs to be covered by the study
  2. All costs to be covered by the owner
  3. Funds available to cover adverse events (if applicable)
  4. Monies for technical support (if applicable)
  5. Financial incentive(s) to owners for participation and how disbursed
  6. Source(s) of funding (e.g., to cover adverse events, sample shipping)

Budget Example

 

F. Informed Consent

All clinical trials conducted in the VMC require informed consent of owners and must clearly state the costs for which the client is liable in the event of complications. Please attach a copy of you informed consent to this application. Examples of general and specific consent forms are found below.

  • Have you included a brief lay description of your clinical trial? This should be readily understandable by the average pet/animal owner.
  • What costs are covered by the study? Be very specific.
  • What adverse events/toxicities are possible (describe all potential toxicities including death) and how will they addressed? (i.e., who will treat the animal in the event of toxicity, who will pay for the treatment?)
  • Does the owner have the option of withdrawing from the study? What are the consequences of early withdrawal with respect to financial compensation?
  • In the event of animal death, is a necropsy required?
  • Include a statement indicating that the owner understands all aspects of the study.

Informed Consent Examples

Animal Use Protocol Approval

Any study that will utilize client-owned animals is considered a clinical trial, and all clinical trials conducted at the OSU Veterinary Medical Center currently require approval from the IACUC (Institutional Animal Care and Use Committee) unless the Clinical Research Advisory Committee has determined that such approval is not required, in which IACUC would provide an exemption letter . It is suggested that you contact Dr. Allen (allen [dot] 1243 [at] osu [dot] edu) to determine whether you may be exempt from this requirement. In general, any study that involves procedures/treatments that would not be routinely part of standard of care for a particular disease (i.e., collection of additional blood samples, additional imaging, etc.) will necessitate obtaining IACUC approval. For clinical trials at the VMC, an Animal Use Protocol is used. IACUC requires that all individuals listed on an Animal Use Protocol complete the online Animal Training courses, along with their Experience and Training Narrative.

  • Submit a Animal Use Protocol form to the Office of Responsible Research Practices.
  • List the number of your approved Animal Use Protocol or exemption letter on your title page and provide the Clinical Trials Office with a copy of the approval or exemption letter.

Research Administration Toolbox

Forms

IACUC Training

All personnel listed on an IACUC will need to complete the online training courses (except Facility Training), along with their Experience and Training Narrative.

Good Clinical Practice (GCP)

Good Clinical Practice is 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.

12 Golden Rules

  1. Investigators must have appropriate qualifications and time for study
  2. Know and follow the study protocol
  3. Provide sufficient qualified and capable study personnel
  4. Carefully select suitable patients
  5. Obtain informed consent and protect animals’ welfare
  6. Ensure study facilities and equipment are adequate
  7. Record all data carefully
  8. Meticulously Document product accountability
  9. Collect and record adverse events and changes in animal health
  10. Ensure the appropriate handling of study laboratory specimens
  11. Maximize data quality
  12. Maintain good trial files and perform study conclusion tasks

Grant Support

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