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FEE SCHEDULE: JANUARY 2020
PROTOCOL REVIEW ...........$3150.00
Includes:
- Study Protocol & Amendments
- Investigator's Brochure
- Investigator's Curriculum Vitae, Licence, Site Questionnaire
(1-15 sites - initial submission by sponsor or one group)
- Patient Information and Consent Form (one form only included in
initial
submission fee.
For studies involving more than one form, please add
additional document fee as described below)
- Advertisements (if required)
- Communication with outside experts (if required)
(Included items must be submitted at time of initial protocol
review. Items submitted separately will be billed accordingly.)
PROTOCOL AMENDMENT/CONSENT FORM REVISIONS/CONSENT FORM
ADDENDA
$ 250.00 per item
(submitted after the initial review date)
ADDITIONAL CONSENT FORMS
(for studies involving more than one consent form)
$250.00 per item
ADDITIONAL INVESTIGATORS/SITE,
ADVERTISEMENTS
(per item)
review of an additional investigator/site for a previously approved
protocol
$ 150.00 per site
(for reviews involving more than 15 sites, fees are negotiable)
ANNUAL REVIEW
Studies which extend beyond the one year require an annual review
(up to 15 sites)
$ 1100.00
(Each additional site $50.00)
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 GST. Fees are subject to change.
Please contact us at
optimumerb@yahoo.com with any questions about this schedule.
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Mailing Address
442 Athol St. E., Oshawa, ON
L1H 1L4
Main
Office
604 Taunton Rd. W., Oshawa, ON
L1L 0N9 |
