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Reports of New Information

A Report of New Information (RNI) is used to provide the IRB with any issues or relevant new information. See SOP RNI Reporting by Researchers [1] for more information about what should be reported.

If you need to submit a PAVE report, see PAVE Reports in Zipline [2] for more specific instructions.

The RNI submitter is the only person who can respond to any clarification requests about the RNI. The RNI may be linked to one or more studies, sites, or modifications when the RNI is submitted, but it is not required. HSD can also link studies, sites, and modifications to a RNI at any time during review. The RNI submitter has full access to edit the RNI. However, the PI, any PI proxies, the primary contact, and study team members of all related (linked) studies are given read-only access to the RNI submission. The PIs, PI proxies, and primary contacts receive the same e-mail notifications as the RNI submitter throughout the workflow.

Table of Contents

Submit RNI

1. Click Report New Information from My Inbox, or from a related study or site

screenshot of the Report New Information button
2. Enter a short title for the submission

3. Enter the date you became aware of the information

4. Select the category (or categories) that best represents the new information being reported

screenshot of the RNI categories

5. Describe the event and what, if any corrective action has been taken or is proposed

6. Indicate your assessment of the RNI

screenshot of RNI question 5

7. Associate (link) any modifications [5] (if created) you are proposing because of the RNI and associate (link) any study(ies) that the RNI relates to

screenshot of the ellipsis button to select related studies and modifications

Screenshot of associating a study with an RNI

8. Upload the RNI Supplement [6] as a supporting document if the RNI involves safety monitor or DSMB reports OR research-related problems or events

9. Click Save and Exit to leave the SmartForm

10. Click Submit RNI and click OK to complete required verifications

Screenshot of the Submit RNI button in Zipline

The RNI transitions to Pre-Review state and is now in HSD’s queue for review.

screenshot of the RNI in Pre-Review state

Once HSD and the IRB have reviewed the RNI, the submitter will receive a notification that:

Respond to Action Required

After reviewing a Report of New Information (RNI), the IRB may require specific actions to be taken in response to the reported issue. A responsible party is assigned by the IRB to complete the action. The responsible party can respond using the Submit Action Response activity when the action has been completed.

The system sends an email to notify the responsible party and the submitter of the RNI, as well as the PIs, PI proxies, and primary contacts of all related studies. The RNI also appears in My Inbox for the responsible party.

1. View the details of the RNI submission and the IRB’s required action plan, as described here:

Screenshot of the RNI workspace with the action letter, view RNI, and action plan tab highlighted

2. Take the actions required to complete the action plan

3. Prepare your written response as a document to upload or copy and paste into the activity

4. Click Submit Action Response to indicate that the action plan is complete

Screenshot of the Submit Action Response action in Zipline

5. Add your written response in the notes field or as an attachment, including a summary of the actions taken to resolve the reported issue and complete the action plan and click OK

screenshot of the submit action response window