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!