How to Respond to a Stipulation to a Study Applications in iRIS

1. Receive the email with stipulations
   
   1. iRIS will send an email after the IRB staff and/or IRB members have reviewed the any type of
      application. It will send stipulations for both pre-review and post review corrections.

i. Click on the link in the email to log into iRIS to link to the iRIS home page.

ii. Alternatively, you can log-in to iRIS normally to get to the home page.

2. Navigate to Review Response page
   
   1. From your iRIS home page, click on “View All Tasks.” The page will shift down to the “All Tasks”
      section of the page. This section lists the outstanding tasks which are waiting for you to work on
      them. Click on the icon of a notepad and pencil next to “Submission Response.”

i. Note: you may access your study in other ways, but if you do so, iRIS will not recognize that you are responding to a stipulation, and you may not be able to fully make the changes you need. You can always come back to the home page and click on this task to come back to the Review Response page properly.

b. That link opens the Review Response Form page with all the stipulations listed below.

3.      Overview of the Review Response page

a. If you are new to using iRIS, it is a good idea to familiarize yourself with the various sections and features of this page by reading, Overview of the Review Response Page.

4.      Respond to each stipulation in the Application

a. First, take note of the section the stipulation references and the application question it refers to, and read the description of the stipulation from the reviewers.

b. Second, click on the “Book” (read-only) icon to view (not edit) that section of the application and your original response to that question (you can also click on the component name and version number). Note: You will not be able to make any changes through this link!

c. Click on the “Back” button to return to the Review Response page listing the stipulations

d. Now, on that same stipulation, click the button at the top, right-hand side of the section, “Revise Existing.” This creates a revision or new version of your application. You will get a pop-up message asking you to confirm. Press, “OK.”:

i. Note: When you press any button to edit or revise your submitted application, iRIS does NOT make any changes to it—instead, iRIS will create a copy of your application, and that copy will become a new version. This allows you and the reviewers to compare the changes in each version.

ii. Note: If you do not see the “Revise Existing” button, please see the pro-tip at the end of this document.

e. This will bring you back into the application, but in a new version that you can edit. Click into the appropriate field to make the required changes, then press, “Save Section.”

f. Next, click on the “Back” button to come back to the “Review Response” page listing the stipulations. In the comment field for that stipulation, describe the changes that you just made, and press “Save Form” at the top, right-hand corner of the page.

g. If you feel you have satisfied the stipulation requirement fully, mark the “Complete Action” radio button and press “Save Form” again.

h. Progress to the next stipulation where you can repeat steps a-g.

***The instructions above pertain particularly to stipulations for items in the study application. For stipulations regarding items in the submission packet (such as consent forms, questionnaires, missing documents, etc.) the steps are similar, but have some variations, as described in How to Respond to a Stipulation in iRIS – STUDY DOCUMENTS.

 
5. Sign off and Submit When all the stipulations have been responded to and completed, click on the “Sign off and Submit” button at the top-right-hand side of the page. This will take you to the page asking you to certify your submission as accurate… and you can officially submit your response to the review. For more details on how to Sign off and Submit, please see How to Submit your Responses to Stipulations in iRIS.

Pro-Tip 1:

If for any reason it does not show the “Revise Existing” button, and it instead shows the “Compare Application Version” button, you can

1. Click on the notepad icon next to the newest version name of your application.

2. Or you can go to the “Submission Documents” section at the bottom of the “Review Response” page and click on the newest version of your application, scroll to the section referred to by the stipulation, and make the appropriate changes there.