Renewal/Continuation of an Approved Protocol for e-Protocol Submissions
When approval for your protocol is about to expire, you will receive an email indicating that you must submit a renewal or final report form.
To renew a protocol, go to the e-Protocol website and login.
From the main screen, click on the circle with the double arrows to the right of Protocols (Approved) in the menu on the bottom left of the screen.
Click on the protocol number that you wish to renew.
A window will open with several options.
Click the circle beside Start Renewal .
The protocol will open with a renewal form. Fill out all of the information on the form.
If your renewal involves changes to the existing protocol, including changes in the number of subjects, proceed to the appropriate sections, using the menu on the left of the screen, and make the necessary modifications. Sections that have been modified will be indicated to the IRB. You will only see the latest text on your screen. However, for IRB members the changes will automatically be highlighted, and the original text will be available.
Once your changes have been made, check that all information has been entered by clicking on Check for Completeness in the menu on the left. When you are ready to submit your renewal, click on Submit Form in the menu on the left.
Once the renewal is submitted, the protocol will appear in two places within your account. The originally approved protocol will appear under Approved Protocols . The renewal form will appear with the same protocol ID on the main page of your account, with the Protocol Event as Submitted .
All future correspondence regarding the renewal application will have the original protocol ID number, followed by [Renewal].
Once the renewal has been reviewed by the IRB, you will receive an email stating the decision of the IRB. If changes need to be made to the protocol, you will need to login to e-Protocol and open the appropriate protocol for editing, by clicking on the item listed for that protocol under Protocol Event . Within this protocol you will find comments from the reviewers and/or the IRB staff. You must make all recommended changes and re-submit the protocol.
When the renewal has been approved by the IRB, you will receive an email stating so.