Institutional Review Board

NOTE: These instructions are specific to Continuing Reviews (CR) for single IRB (SIRB) studies using the ERICA "Site-Control Model". Instructions for all other types of Continuing Reviews can be found on our Continuing Reviews & HRPP Progress Updates page. For all revisions to approved documents, remember to attach a tracked and clean version of your documents with the application.

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. We conduct these reviews using a Continuing Review (CR) application. For studies that don't have expiration dates, we ask for regular updates using a Progress Update (PU) application, which uses the same application type as CRs.

STEP 1: Prepare for deadlines.

Submit your CR or PU no later than 8 weeks prior to expiration or anniversary date. If a CR application is not submitted by the expiration date, the study will automatically be closed and a new study application must be submitted to continue the research. If a CR application is submitted but still in review by the expiration date, all research must pause until IRB approval is renewed. 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 2: Create and complete your Continuing Review application.

• The CR application can only be started by the overall Responsible Principal Investigator (R-PI) or the main study contacts. Site contacts can only edit their own site's applications.
• In ERICA, click on your "IRB" tab.
• Select the “Approved” sub-tab to see what studies you are listed as a contact for. Note that you can sort the studies on your tab by clicking the column header.
• Click on the study you want to open. You will be directed to the study's "main workspace".
• To begin a CR or PU Application, select the tab for “Continuing Reviews”.
• 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.

STEP 3: Fill out the Continuing Review Application.

• After clicking the "Create" button, you will be directed to the first page of the Continuing Review application.

  NOTE: Final Project Reports are also started from the Continuing Review application. If you’ve been asked to submit a Final Project Report to close your study, that is triggered from the first page of a new CR  application using the following information:
  
  

• Click “Continue” through the application and complete each page according to the on-screen instructions.

  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.

STEP 4: Attach your Tracked and Clean Documents.

• On the Documents page of the Amendment application, you can attach documents for IRB review. If the pSite Amendment includes any changes to previously approved, site-specific documents, attach tracked and clean copies of your documents in the appropriate section of the Documents page.
  • Changes to study wide documents/templates should be made via a study wide Amendment, not a pSite Amendment.
  • Documents on pSite applications should be site-specific versions of the documents approved on the main (study wide) application.
  • Documents that must include the IRB approval stamp (i.e. consent forms) must be formatted properly for ERICA before attaching. Please review our guidance on Submitting Documents for IRB Approval for instructions.

STEP 5: Check for errors.

• After completing the CR application, it is recommended that you click the “Validate” button in the top left of the page to check for any fields that may have been missed and are required to be filled out before the application can be submitted. Clicking on the blue help text to the right of the warning icon will redirect you to the missing fields in the application. If there are red error messages those must be resolved before the PI can submit in ERICA.
  

OPTIONAL STEP: Adding an Amendment.

• If you would like to include an Amendment (AM) with the CR, you can "attach" an AM to the CR by answering "Yes" to the question "Are there any changes to be made?"
• After you complete the CR application, you can navigate back to the main CR workspace page. This page will vary based on whether a CR or a CR + AM is being submitted.

  Standalone Continuing Review	CR with Amendment

  CRs that include an AM include the “Update Study” button on the main CR workspace so the changes you wish to make to the study can be added before the CR is submitted. Clicking "Update Study" will take you to a copy of the currently-approved main study application. Make the changes you need to, and when the CR+AM is approved and processed, the changes you make to the copy will be integrated into your main study application.

   

STEP 6: Submit the Continuing Review.

• Once the details of the CR have been provided, and there are no validation errors appearing on the edit page, submit the application to the IRB by clicking "Submit" under the Activities menu.

  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.

From there, your Continuing Review will be sent to the IRB's general assignment queue and routed to a reviewer from there.  Track the progress of your application by monitoring the state label on the CR workspace. Our ERICA Status Key can tell you more about each status label. Estimated review times can be found on our Submissions & Review Schedules page.