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Pre-trial Protocol Review is Required.
VOHC provides a Pre-trial Protocol Form to be used when submitting a draft Protocol for pre-trial review. The form contains all of the information needed to allow VOHC to ensure that the trial will meet VOHC Protocol requirements.
For details of the VOHC protocol and trial requirements, please visit the Protocols page.
Submit the completed Pre-trial Protocol Form via email to VOHC@AVDC.org
New Submission Format
Order of Items in a Submission
- The following items are to be included in the Submission:
- 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 or equivalent:
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.
- The Trial Protocol Form as approved by VOHC during Pre-trial Protocol Review, in Word format. Add in Red Font any items that were changed following pre-trial approval, with an explanation for the change.
- Results, as a summary table showing the mean mouth scores of each group and % difference between groups (defined as: [Control minus Test] divided by Control x 100), 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 identification number or name, 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.
- Include a table of Gingivitis score results, including % difference between test and control groups.
- A statement that the trial was completed as per the protocol, or a description of 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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