IRB Review Continuation Review (CR)/Annual Administrative Review (AAR)

• Continuation Review Report (SAMPLE) [F14.0000] [PDF]
• Annual Administrative Review Report (SAMPLE) [PDF]

Please note that the SAMPLE CR or AAR report does not contain protocol-specific data, and you should not complete and submit this form to meet the requirements for Continuation Review or Annual Administrative Review. 

• Continuation/Annual Administrative Review SOP [C2.0250] [PDF]

To initiate a Continuation Review (CR)/Annual Administrative Review (AAR), or Final Review (FR) for closure, find your application under the Approved folder.  Open your application by clicking on the IRB # and select the "Continuation Review (CR) or Study Closure" menu option under the “Create” bar.  Then follow the prompts for completing the CR/AAR/Closure.  If you (or someone else on your research team) have already performed this step, but not submitted yet, you will find the incomplete CR/AAR/FR in your Draft folder.

• Food and Drug Administration (FDA) Continuing Review After Study Approval
  Guidelines from the Food and Drug Administration (FDA) Information Sheets.
• Office for Human Research Protections (OHRP) Compliance & Reporting
  This web page provides information regarding types of determinations, determination of noncompliance issued over over several years, etc. 
• Office for Human Research Protections (OHRP) Guidance on Continuing Review  - November 2010
  This document describes the requirements of Department of Health and Human Services (HHS) regulations at 45 CFR 46.109(e) for the continuing review of human subjects research by an Institutional Review Board (IRB).
• UK ORI Time-Saving Tips for Continuation Review of an IRB-Approved Study [PDF]
  Tips developed to help researchers with submission of Continuation Review materials.
• UK ORI Requested Revisions from a Full Review - Major versus Minor Determination [PDF]
  Guidance on whether a convened IRB request should be designated as minor (vote #2) or major (vote # 3 or 4)