Reorganization of Info in Application’s Blue Banner

Your application’s banner will still contain all the same pertinent information about your application; the information has just been re-organized, and the tools for printing the application and returning to your Dashboard have been shifted to the Application Links menu as shown in the next section:

How to Print Your Application and Return to the Dashboard

The tools for returning to your home Dashboard and for printing your application to PDF will be the first two menu options located under the Application Links menu on the left of an application that is pending review/approval:

Currently approved applications will not have the Print Protocol menu option because the ProtocolPDF is readily available for opening on the default landing page:

How to Create a new Modification Request (MR) or Continuation Review (CR)

The menu options for creating a new MR or CR will be housed under the currently approved application when the application is eligible for one or both of these application phases. 

For example, to create an MR for an application that doesn’t already have an MR, CR, or study closure request created, you will need to find your application under the Approved folder first, open it, (Steps 1 and 2 in below screen shot), use the Modification Request menu option under the “Create” bar (Step 3 in second screen shot), then follow the prompts for completing the MR:

The Create MR and CR/Study Closure menu options will only be available if no other phases of your application have already been created (e.g., an other MR, a CR/AAR, or Administrative Study Closure (‘Other Review’)). For example, if you have already created a CR, you will not have the menu option to start another phase -- the CR will need to get reviewed and approved before that study is eligible for a new CR or another MR to be created, and vice versa. Applications certified as exempt do not undergo Continuation Review so that menu option will not be available for them.

If someone has already created a DRAFT MR, CR/AAR, or Study Closure and you are personnel with edit authorization, you can open the MR or CR/AAR and cancel that draft using the "Cancel Submission" option under the APPLICATION LINKS menu, or open the draft Administrative Study Closure from under the ‘Other Review’ tab and click the Delete button at the bottom of the form. These actions will not delete any previously approved version of your application.

How to Create an ‘Other Review’

The menu options for creating a new Deviation/Exception, Protocol Violation, and Unanticipated Problem will be housed under the currently approved application. Find your currently approved application as instructed above in “How to Create a New Modification Request (MR) or Continuation Review (CR)”. Then select the applicable ‘Other Review’ and follow the prompts to complete the submission.

Note that there is an option to create an Unanticipated Problem Report for Inactive applications, as well as new submitted IR applications (not yet approved). Open your application from under the applicable folder (‘Inactive’, ‘Submitted’, or ‘Inbox’) to view the menu options on the left-hand side:

Edit-Indicator Color Change

The update also involves a change in how the system indicates an edit has been made to an application. Currently, when a change has been made to a previously-submitted application, the section title text turns red, and the affected question is outlined in red. Once the system update has been implemented, a gold background for the section title and a gold outline for the affected question will indicate changes, as shown in the following sample screen shot.

Based on user polls and other feedback received, we expect these changes to be more intuitive, and to minimize erroneously created application phases and 'Other Reviews'.

Most of the E-IRB Video Tutorials will need to be updated to reflect these changes and that will take some time, so please be patient while that task is underway and feel free to share the news with your co-workers.