- About the VMC
- Pet Owners
- Farm Animal Owners
- Horse Owners
- Clinical Trials Office
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.
First you will need to contact the Clinical Trials Office by submitting the CTO form to the Clinical Trials Coordinators (Nicole Stingle or Tamra Mathie at clinicaltrials [at] cvm [dot] osu [dot] edu).
Second you will need to fill out each page of the CRAC form. Once completed, you should submit your CRAC form to the Clinical Research Advisory Committee, c/o Matthew Allen (allen [dot] 1243 [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
The title page is actually a brief synopsis of your proposed study, so you want to include:
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.
This section allows for you to select the appropriate description.
Describe how your study will impact daily operations of the VMC including:
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.
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.
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.
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 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