Institutional Review Board

Continuing Reviews (CR) Applications are also referred to as “Renewals”. Federal regulations require that some studies are reviewed at least annually, so research that is initiated, funded, or supported by the U.S. Government is reviewed on at least an annual basis. In addition, the IRB reviews all research that is greater than minimal risk at least annually.

Additionally, if you’ve been asked to provide a Progress Update (PU) for your study, this will be done as a CR application. A CR will be of a Progress Update type when a study is either “Approved” or “Exempt” and does not have an expiration date, rather has an anniversary date that does not change year to year. An expiration date will update depending when board reviewed for renewal year to year.

Continuing Review applications are recommended to be submitted 8 weeks prior to expiration, this is to facilitate any required ancillary reviews. If a CR application is not submitted by the expiration date, the study will automatically be closed and a new application must be submitted to continue the research. If a CR application is submitted but still in review by expiration date, all research must pause until approval is granted.

Progress Update applications can be submitted up to 60 days prior to the anniversary date, and if a PU is not submitted by that date the study will automatically be closed and a new application must be submitted to continue the research. If a PU application is submitted but still in review by the anniversary date, research can continue.

Step 1: Main Study Continuing Review Application

1. Navigate to ERICA, login to the system.
   On the IRB Tab, select “Approved” tab to see what studies you are listed as a contact for, and so can create applications. Note you can sort the studies by ID (IRB number with UU SIRB), study name, state, the lead Responsible Principal Investigator (R-PI) PI name, or by date needing to submit by. Just select what column.
   Select the study to open it’s main workspace. To being a CR or PU Application the process can be started from the main workspace page of the study by the overall Responsible Principal Investigator (R-PI) or the main study contacts. Site contacts can only edit the site application they are listed on.From the center table select the tab for “Continuing Reviews”.
2. Click “Create” to start the process of creating a Continuing Review.
   SITE-CONTROL NOTE: If your study is using the Site-Control Model where you have participating sites (pSites) with their own smaller applications, clicking “Create” will also create mini CR applications for each of the activated sites.
   Click on the “Sites” tab on the main protocol workspace to see the study sites. You will see a new application for each site in “Creation” status.
   
   A notification is automatically sent to the site to let them know they need to complete their site’s CR information. Make sure the majority of your sites have submitted their CR BEFORE you submit the main CR to the IRB. You can check the status of each site CR from the “Sites” tab.
3. After clicking the button, you will be taken to a new page that will resemble all the other application entry pages that have been used so far during the study’s approval process. Like when the application is initially created, the left-hand menu only starts with one page asking about the status of the study.
   NOTE: If you’ve been asked to submit a Study Final Project Report or closeout a study, that is triggered from the first page of a new continuing review application using the following information:
   
4. Once the status information is provided, and the “Continue” button in the bottom right of the page is clicked the editing page will change and update. You’ll now see that the page says “Editing: (CR Number)”. This CR number is like the IRB number in that it’s the unique identifier for the continuing review application. Also, note the left-menu now has more pages added to the application process.
5. From here the continuing review application will vary depending on the content of the study and its requirements.

   SITE-CONTROL NOTE: If your study is using the Site-Control Model where you have pSites with their own smaller applications, pay close attention to the “Progress of Sites and Enrollment” page. Each of your sites will be listed here, and if the site has completed and submitted their pSite CR, their enrollment information will appear on the table. If the information is missing, the site hasn’t completed their CR yet.

6. Just like when the application was initially filled out in the top left corner of the page there is a button which says “Validate” that can be used to find out if there are missing fields on the application. Clicking on the blue text next to any of the warning messages will navigate to the affected area in the application.If there are red error messages those must be resolved before the PI can submit in ERICA. You can select the Blue hyperlink title to be taken to the page/question that needs input. If you have green checkmarks, there are no errors and the application should be able to be submitted without issue by the PI.Reminder – only the PI can submit in ERICA, a site PI for site applications and the overall R-PI for the protocol/main application. A R-PI can submit on behalf of a site, but does require going into each site application as well.See image below for example of when errors are present in the continuing review application.
   
7. One important page to note in the CR application is the “Amendments” page. As part of a CR an amendment can be made to the study application at the same time. If this is necessary, then select “yes”. The application will add all the information that’s used in an amendment application to the continuing review application. You can refer to the guides on amendment creation if you have questions on the amendment process.
8. Once all the required information has been provided and the validate button shows no errors, you can navigate back to the workspace page for the continuing review. This page will vary based on whether a continuing review with amendment is being submitted or a standalone continuing review is being submitted.

   Standalone CR	CR with Amendment

   Continuing reviews that include an amendment include the “Update Study” button on the main workspace so that changes can be made to the study application before the continuing review is submitted. Clicking on this button will take you to the form edit page for the overall application where the necessary changes can be made.

9. After the necessary information has been entered into the application you can click the “Submit” activity and move the continuing review forward in the approval process. Once this is completed the status of the continuing review application will change. If you have any questions about what the status means, please refer to the Application Status Key.

   SITE-CONTROL NOTE: If your study is using the Site-Control Model where you have pSites with their own smaller applications, pay close attention to the comment box that pops up when you click “Submit”. You will be able to select each site that has submitted their pSite CR and “bundle” them to the Main CR. Any sites that have not completed their site CR will not be able to be selected and will be left behind. All sites MUST complete their pSite CRs eventually, but the Main CR can progress without them.