Submissions: Submission Format
This page provides information on how to format a draft Protocol for pre-trial review and how to format the final version of the Submission following completion of the required trials.
For details of the VOHC protocol and trial requirements, please visit the Protocols page.
Format of a Protocol for Pre-trial Review or a New Submission
Pre-trial Protocol Review is required. Include items 1, a-j, below, in the order shown, as email attachments.
Submissions for Review:
Submit items 1, a-j, and items 2, a-g, below in the order shown. Submissions are to be made electronically as email attachments, except that one printed signed copy of the submission cover letter and affidavit must be submitted by mail to the VOHC office; this will normally accompany the fee payment.
Order of Items in a Submission
- The Protocol file is to include the following items, in the order shown. Further details of these items are available in the Protocol Details page.
- Title page, with name of the specific product(s) and the specific claim(s) [plaque and/or tartar] requested for VOHC review, and name and contact information of the responsible official who will be the VOHC contact person during the review.
- Brief description of the product, including the method(s) by which it achieves its effectiveness as an anti-plaque and/or anti-tartar agent, the population of animals for which the product will be marketed, and any instructions or limitations for use of the product that are or will be stated on the package (such as recommended frequency of use, minimum number or amount of product to be used, body weight range of animals per size if more than one size is marketed).
- A statement of the type of trials conducted to fulfill the requirements for this specific type of product, including two trials of one product (or size etc. of product in a product line.
- Site (location) and proposed or actual start and end dates of the trial.
- Personnel involved: Investigator, supervising veterinarian and scorers if different from the investigator, including a summary of relevant training and experience of the scorer(s), and statistician if a statistician was consulted. A summary CV is sufficient.
- Management of the animals during the trial – a brief description of:
- Care of the animals including housing and diet (with specific confirmation that the diet fed to the control group during the trials is a commercially-available AAFCO-standard dry food diet, fed dry.
- For laboratory-housed animals, confirmation of review of animal care procedures and the purpose of the trial (e.g. IACUC approval, AALAC certification).
- For client-owned animals, a copy of the Owner Document (consent form and instructions for participants in the trial) and Owner Daily Report form.
- Population studied, including in the Submission the age, breed, sex and ID # or name of individual animals listed with group assignments - these data can be included in a separate electronic spreadsheet. State the number of subjects per group.
- Randomization process used to assign individual animals to the trial groups.
- Time line and description of procedures used in the trials, including pre-trial stratification if conducted, including:
- Detailed description of the scaling procedure used to create the ‘clean tooth model’, including summary of anesthesia and confirmation of intubation during anesthesia.
- Description of the dental indices (plaque and/or tartar [calculus], gingivitis) used or to be used. Provide references, or provide a detailed justification if a new method is to be used.
- Confirmation that the mouth will be/was observed for non-gingival inflammation, or oral ulceration or laceration on Day zero and at the final scoring episode.
- Confirmation that no drugs or oral hygiene products or procedures will be/were used.
- Statistical analysis procedures, in sufficient detail that the VOHC statistician could repeat the analysis.
- The following items are to be included in the Submission only:
- A cover letter that includes the name of the specific product(s) and the specific claim(s) [plaque and/or tartar] requested for VOHC review. The cover letter is to be signed by the responsible official of the submitting company, and is to indicate to whom VOHC correspondence regarding the submission is to be sent.
- The submission fee.
- An affidavit signed by the primary investigator and by the responsible official of the sponsoring company, stating that the information submitted is complete and true, and including the following statements, with signature validated by a Notary Public:
I, as responsible official for (company) certify by this signed affidavit that (company) has complied with all safety and regulatory requirements in the jurisdictions where the product is marketed, that there is no information at the time of the VOHC submission that the product is unsafe, and that (company) will promptly inform VOHC of any reports or regulatory actions concerning the safety of the product. I acknowledge being aware of VOHC policy that the company and its representatives are not to make any mention of VOHC relative to the product until such time as the review process has been successfully completed and the VOHC – Sponsor Agreement has been signed by both parties. I acknowledge that I am aware that VOHC can elect not to continue with the submission review process if the sponsor is not in compliance with this requirement.
- Results, as a summary table showing the mean groups scores and % difference between groups, plus a paragraph or table describing the results of the statistical analysis. The individual tooth scores and mean mouth scores for each animal are to be included in electronic spreadsheet format. Include also the body weight (at Day -1 or Day zero), age and sex of the individual animals.
- If the submission is for both plaque and tartar claims, include separate tables of results and analyses for each claim.
- A statement that the trial was completed as per the protocol, or a description any out-of-protocol events.
- Indication of any areas in which the submission does not meet specific VOHC requirements, with reasons why VOHC should consider such departures from its stated policies or requirements. This could be anything from a notation that one animal was missing one of the recommended teeth, to use of an entirely new method of scoring plaque or tartar.
- Samples of the product (25 samples of individual treats, gels, dentifrices or brushes/devices, or one bulk package of a dietary product or one bottle of a water additive) are to be shipped to the VOHC office when the submission is sent for review; include also one sample of a placebo product used in trials of a gel or dentifrice. If the submission is on behalf of a piece of equipment that would be expensive to send as samples, contact the VOHC office – a video of the equipment in use may be sufficient.
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