The IRB must conduct continuing review of approved protocols for the purposes of renewal of the IRB approval period, at intervals appropriate to the degree of risk and according to IRB policy. Approval periods are issued consistent with IRB Standard Operating Procedures (SOP). The Continuing Review application must describe current enrollment, ongoing enrollment, adverse events, withdrawals, progress of the study, and any amendments/changes. Continuing Review applications should be submitted eight weeks before the study expiration date.
Please Note: For-profit and/or industry sponsored studies must pay IRB fees before the review process begins.
If the Principal Investigator has not completed study enrollment and/or procedures and the study expires, he/she must immediately cease enrollment and all other activities related to the study. If the study expires before a continuing review application is submitted, the study will be administratively closed. If a study is closed before the study is complete, a New Study application must be submitted to the IRB to continue research activities. The investigator may not continue until he/she has received IRB approval to do so.
Continuing Review Application Submission Requirements
Investigators applying for continuing approval of a research protocol must submit the following documents in the ERICA update study application along with the completed ERICA continuing review application. Documents previously approved are retained in the ERICA system and are included in the ERICA continuing review application.
If changes are made to any previously-approved document, a draft copy that highlights these changes for comparison must also be submitted. No new forms or documents will be reviewed or approved without an amendment application.
Documents should be attached to the Documents and Attachments page of the update study application or completed in the application as indicated. Templates for documents can be found on the IRB Forms page.
Submitting a Continuing Review Application in ERICA
- Open the study.
- Click on the Continuing Reviews tab.
- Click on the Create button.
- Complete the continuing review application entirely.
- Attach any updated/revised documents to the Update Study application including new consent documents that need to be approved for another year.
- Submit the continuing review application to the IRB for review.
Note: It is the PI's responsibility to handle the submission of information. This includes the submission of all applications pertaining to the study, as well as revisions requested during the IRB review of an application.