Create and Submit Reportable New Information

Show me: Create and Submit Reportable New Information  

To create a reportable new information (RNI)

1.  the Top Navigator, click IRB and then Submissions.
2. Click the Report New Information button.
   Note: You can also open an active study and report new information from the study workspace.
3. Complete the Reportable New Information page. Pay attention to the following questions:
   Related studies and modifications: Select a single study that the RNI applies to, then save the SmartForm. After saving, you may also select a related modification, if applicable.
   Reporting Participating Site and Affected Participating Sites: If the RNI impacts a participating site, select a single site for both fields.
4. You must attach an RNI Supplement.
5. Click Continue.
6. Then click Finish.

To submit an RNI

1. From the RNI workspace, click Submit RNI.
2. Click OK.
3. Click Submit.

The RNI has been submitted to the IRB. After reviewing the RNI, the IRB may require specific actions be taken.