IRB Forms and Applications for Continuing Reviews/Renewals, Progress Reports, & Final Reports/Study Closures

If approval for continuation is not granted prior to the expiration date of the protocol, all recruitment and subject enrollment must stop. Currently enrolled subjects should continue to receive treatment and follow-up that is in their best interest. Consistent failure to submit timely requests for continuing review is reportable to the FDA, OHRP, and the study sponsor.

Click here to access your study electronically in Cayuse IRB

Progress Reports

During Initial review, the IRB Reviewer will determine if Expedited studies can utilize the streamlined Progress Report to renew approval for another review period. The initial IRB approval letter will indicate whether or not your Initial study requires a Progress Report of a Continuing Review to be submitted. 

• To submit a Continuing Review first open your study in Cayuse IRB, click on the blue New Submission buttong, and then select/click on the "Renewal" option.
• Then in the submission, select "Progress Report" and complete the Cayuse sections in the submission
• Once complete be sure to have the Co-PI, Primary Contact, or PI click the "Complete Submission" button and then the PI will have to certify the submission to move it forward and send it to the IRB administration for review and approval. 

 

Continuing Review / Renewal

Expedited studies that are not designated as requiring a Progress Report and all Full Board Review studies require the submission of a Continuing Review prior to the study expiration date. Continuing Reviews are meant for all studies that more than Minimal Risk, involve the collection of Private Health Information, or other considerations including sensitive or vulnerable population considerations as indicated by IRB Reviewers during the initial review. 

• To submit a Continuing Review first open your study in CIRB, and click on the "Renewal" option using the blue New Submission button
• Then in the Renewal submission, select Continuing Review and fill out all of the required sections.
• Once complete be sure to have the Co-PI, Primary Contact, or PI click the "Complete Submission" button on the main page of the Continuing Review to submit to IRB for review. The PI will need to certify the submission to send it to IRB administration for review and approval

A study specific Investigator Financial and Other Personal Interest Disclosure Form is required for all research personnel listed on the IRB application when submitting a Continuing Review Form. Click on the link below to obtain an Investigator Financial and Other Personal Interest Disclosure Form. Please note, all research staff are required to re-sign and date the form every year. 

• Investigator Financial and Other Personal Interest Disclosure Form

Final Report / Study Closure

Principal investigators have the responsibility of informing the IRB when a study has been completed.   If a study is completed and not closed, the IRB may not approve a new study until the completed study is closed. A study is considered to be open and active until the investigator has submitted an electronic version of the Final Report to the IRB.  When Final Reports are submitted, an administrative review will be conducted by the IRB staff.  IRB Chair/IRB Director will review the form and report the closure of study to the IRB.

• To submit a Final Report, open your study in CIRB, click on teh blue New Submission button, and select/click the "Closure" option. 
• In the Cayuse IRB closure submission, fill out all of the required sections.
• Once complete be sure to have the Co-PI, Primary Contact, or PI click the "Complete Submission" button in the Closure submission. The PI will have to certify the Closure submission to send it to IRB administration for review and approval.