Guidelines for Formulating, Writing and Submitting Clinical Trial Proposals

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 will need to fill out a Title Page (see #1 below) and place this in front of your complete study protocol. Additionally, for items #2, #3, #4, #5, and #6, on a separate page after the Title Page, please indicate where in the text of the proposal these items are addressed (you can use page numbers to indicate their respective locations). A copy of the animal protocol/letter of protocol approval and a copy of the informed consent (items #7 and #8) should be attached to the back of your proposal. Once complete, you should submit your clinical trial packet to the Clinical Trials Office. You will need to provide this information one month prior to the HEC meeting to insure adequate review and allow time for appropriate corrections. The HEC meets the fourth Friday of every month, so you MUST submit your packet the first Friday of the month. If you need help with this process or have questions, please contact the Director of the Clinical Trials Office (e-mail).

• Directions for Submitting a Clinical Trial Protocol

1. Title page

The 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.
• The location of the study (especially important if the animals will be seen at sites other than OSU, as with collaborations or multiple data collection sites).
• 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).
• Other pertinent information. This means anything that has a major impact on the study that is not included in the previous categories, e.g., technical support, where funds are coming from, if the study is sponsored by an outside agency, if this study supports or is an offshoot of another study (current or past), etc.

2. Summary/purpose of the study

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 detailing your study.

• What is the hypothesis underlying your study?
• How will you test your hypothesis?
• Provide a detailed justification of your clinical trial design and how this will address your study objectives.
• What are the potential limitations of your study?
• How will you address problems should they arise during the course of your clinical trial?
• What is the study timeline?
• Are you repeating any previous studies?

3. Statistical parameters

• Do you have access to a statistician/have you consulted a statistician?
• What statistical tests will be employed? What primary endpoints will be assessed/tested? What is your control group?
• How many animals will you use? Provide a justification for this.
• Is this a pilot study? (certain statistical end points may not apply)

4. Detailed budget

Prior to formulating your budget, it is recommended that you contact Ken Luke (e-mail, 8-8453) in the VTH business office to get accurate numbers on hospital costs. Think about EVERYTHING this study will require, from anesthesia to labor to gauze pads.

• Budget Examples 

5. Adverse events

• Describe any adverse effects that you can envision
• How will you prevent them?
• How will you deal with them should they occur? BE SPECIFIC for each potential event, including modifications to your protocol and supportive
  care that may be required.
• Who will provide supportive care?
• How will the costs of adverse events be addressed (i.e., who is financially responsible?) Is there an adverse event allocation in the study budget?

6. Additional study personnel

• How many other people will be actively involved in this protocol?
• What are their qualifications?
• Are you employing personnel across services? If so, which ones?
• Have you discussed this study with all involved personnel and obtained permission for participation?

7. Animals

Any study that will utilize client-owned animals is considered a clinical trial, and all clinical trials conducted at the OSU Veterinary Teaching Hospital REQUIRE approval from the IACUC (Institutional Animal Care and Use Committee).

• Attach a copy of your animal use protocol application, OR
• List the number of your approved animal use protocol

8. Informed consent

Written informed consent is REQUIRED for all clinical trials conducted at the OSU VTH. Include the following elements in your informed consent and attach this to the clinical trial protocol. An example of informed consent is on the CTO web site.

• 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

• Owner Consent Example
• Informed Consent Example