What if my site has used a translated consent form not approved by Quorum? What if my site has used a translated consent form not approved by Quorum?
Please submit the translated consent form that was used, a letter of explanation, and a completed major protocol deviation/violation form to Quorum with your Site Status Report.
In your letter of explanation, please indicate if you wish to receive a Quorum-approved translated consent form for future use and provide a plan for corrective action to prevent this from occurring in the future. You must indicate what language you want the consent to be translated into and who at your site is fluent in that language.