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Fee Schedule: BA/BE Studies - January 2020 PROTOCOL REVIEW ...........$1350.00 Includes: - Study Protocol & ICF (Fasting/Fed billed as one if reviewed at one meeting) (Items must be submitted for review at the same meeting. Items submitted for review at separate meetings will be billed accordingly.) PROTOCOL AMENDMENT/CONSENT FORM REVISIONS/CONSENT FORM ADDENDA $105.00 per item (submitted after the initial review date) ADVERTISEMENTS/ADDITIONAL DOCUMENTS (per batch of documents) review of ads/additional documents for a previously approved protocol $105.00 per item ANNUAL REVIEW Studies which extend beyond the one year require an annual review (up to 15 sites) $1000.00 NON-ENGLISH INFORMED CONSENT FORM The Board requires translation from a certified translator. This fee applies if arrangements for a translator are made by the Board (at cost) SHIPPING OF DOCUMENTS: The fees above do not cover courier shipping of documents to sites. A courier account number must be provided to Optimum for these purposes, or the actual courier shipping costs will be covered by Optimum and then billed to the submitter/sponsor, plus an additional administrative fee of $5.00 per invoice. RE-ISSUE OF LOST ORIGINAL DOCUMENTS If original documents (confirmed-delivered, to correct address) are required to be re-issued due to accidental destruction or loss of documents, a new original approval package can be re-issued $50.00 per site/package Fees are in Canadian Dollars, plus HST. Fees are subject to change. Please contact us at optimumerb@yahoo.com with any questions about this schedule. |
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Mailing Address |
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Telephone: (905) 723-4694 |