eRAM: Make Application Changes

Overview

During the review process, reviewers add questions to an application in order to request clarification on or additional information about the protocol. These questions are routed through the ACU Office Research Compliance Associate (RCA) where they are reviewed, summarized and then sent to the Principal Investigator (PI). The PI must make the appropriate changes and resubmit the application.

• A complete list of reviewer questions / requested changes can be found on the Reviewer Questions tab in the protocol workspace.
  
• If you choose to work from the Reviewer Questions tab, click the application page link on the first reviewer question and make the appropriate changes to the application. Click Save, and then click Exit.
• Repeat these steps for all listed reviewer questions, and then complete steps 8–9 to resubmit the application.

Alternatively, complete the following steps to address reviewer questions and resubmit the application.

Step-by-Step Process

1. Click Edit Application on the protocol workspace.
   
2. Click the Reviewer Notes quote icon on the first page of the application containing a reviewer question.
   
3. Review the question(s) carefully.
4. Click Close.
5. Make all necessary changes to the application in order to fully address the question(s)/requested change(s).
6. Click Save.
7. Click the Reviewer Note quote icon on the next page/section of the application containing reviewer questions/requested changes.
   Note You may have to click Update to view Reviewer Notes within a pop-up form.
8. Repeat steps 2-6 until all reviewer questions have been fully addressed.
9. Click to Exit the application.
10. Click Submit Changes from the Activities list.
    Note Error checking is performed on the application when it is submitted. If any errors are found, a list displays. All errors must be resolved before the application can be successfully submitted.
11. Click OK.