Before you begin:
Review the guidance for New Information Reporting. Submissions that do not fit within these guidelines will be returned to the submission preparer without review.
Steps to complete the submission:
- Log-in to eIRB+ using your NU NetID and password.
Determine if the new information is applicable to a specific study or several studies.
If the new information is related to a particular study:
- Click My Studies and filter by PI or Study Number.
- Choose the applicable study from the resulting list.
- Click Report New Information. (Located in the left column of the page under My Current Activities.)
If the new information is related to several studies:
- Click Report New Information (Located in the upper left corner of your Inbox.)
- If the new information is related to a particular study:
- A blank application will open. You must complete all questions.
- Select the appropriate category(ies) and provide other relevant information.
You will be asked:
- Does this information indicate a new or increased risk, or a safety issue?
- Does the study need revision?
- Does the consent document need revision? If revisions are required, describe them in the space provided and submit a study modification for review.
- Click Finish when you have completed the application. Please Note: This activity does not submit the form to the IRB Office.
- The PI or PI Proxy must click Submit for the submission to reach the IRB.
Following Your RNI Submission:
The basic process for Reportable New Information in the eIRB+ system includes the following states:
- RNI Review - The designated IRB member/convened IRB panel is currently reviewing the Reportable New Information submission.
- Clarification Requested (RNI Review) - The IRB panel member/convened IRB panel has reviewed the submission and has requested changes or clarifications.
- RNI Review Completed - The designated IRB member/convened IRB panel has acknowleged the RNI submission. No additional changes are required.
Closed - The RNI submission may also be closed by an IRB Coordinator or a designated reviewer if not deemed to be necessary.