Once a review date is established, you provide us with
the documentation listed on the “Submission Checklist”. This may also
be outlined in a submission email. These
documents are promptly organized and forwarded to our members. Board
members require approximately one week to review the initial documents (protocol,
consent form, etc.). At the scheduled Board meeting, the protocol
review will be conducted. Any necessary changes to the consent form
template will be made, and the Investigator/Site documentation will be
reviewed.
If the protocol is approved as submitted, after the
meeting, our Ethics Coordinator will make any/all Board-requested changes
to the consent form. This draft version is then reviewed by the
submitter/sponsor and approved before it is deemed to be the “final, approved
consent form”. The final site-specific stamped (where applicable) version will be
generated using the information provided by the site(s) on the Site
Questionnaire, and this version will accompany the approval letter
that is sent to the site(s).
The initial approval is valid for one year (unless the Board
determines that more frequent review of the protocol is appropriate).
Throughout the year, any amendments to the protocol, consent form or
investigator information, new information regarding the
investigational product, Serious Adverse Event Reports, etc. must be
submitted to the Board for continuing review. All items which do not
require approval by the Board will be acknowledged.
If your project continues for a year or more, you must request
annual review. The expiry date for your approval is stated in bold, at
the bottom of your approval letter. For your annual review, simply complete an Annual
Report Form, attach a copy of the signed consent form (if applicable), and forward to
Optimum ERB. The Board will re-review the protocol and Annual Report
Form(s) from all pertinent sites, to ensure that the study can continue
to be conducted for another one-year period.
When your project is completed, a Final Report Form (or letter of
completion outlining the information requested in the Final Report
Form) must be forwarded to the Board for acknowledgment.
Print a blank
Study Status Report Form
Request a
Study-Specific Report Form
If you have any questions, or would like any further
information regarding Optimum Clinical Research Inc. Ethics Review
Board, please do not hesitate to contact us. We would be delighted to
work with you!
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