Reportable New Information

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Events that occur during the course of the research, such as: unplanned changes, unexpected outcomes of a study, failure to follow an approved protocol, breaches of confidentiality, and subject complaints that cannot be resolved by the research team must be submitted to the IRB as Reportable New Information (RNI). This list is not comprehensive. See the Investigator Manual (HRP-103) for more detailed information on what constitutes reportable information. Some RNIs must be submitted within 5 business days.

“Report New Information” in CATS IRB following the steps below.

Select “IRB” to access the “Active” tab to find all active studies. Select the desired study by clicking on the study name if associating the report with a specific study. Click the “Report New Information” button on the left side of the screen.

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If not associated with a specific study, the “Report New Information” button is available on the home page in CATS IRB.

RNI Button.png

Complete all questions in the form. Then Submit the RNI, by selecting “Submit.” Confirm the submission by verifying the submission state has changed to “Pre-Review.”