Preparing the RNI in eIRB+

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:

  1. Log-in to eIRB+ using your NU NetID and password.
  2. Determine if the new information is applicable to a specific study or several studies.
    1. If the new information is related to a particular study:
      1. Click My Studies and filter by PI or Study Number.
      2. Choose the applicable study from the resulting list.
      3. Click Report New Information.   (Located in the left column of the page under My Current Activities.)
    2. If the new information is related to several studies:
      1. Click Report New Information (Located in the upper left corner of your Inbox.)
  3. A blank application will open. You must complete all questions.
  4. Select the appropriate category(ies) and provide other relevant information.
  5. You will be asked:
    1. Does this information indicate a new or increased risk, or a safety issue?
    2. Does the study need revision?
    3. Does the consent document need revision? If revisions are required, describe them in the space provided and submit a study modification for review.
  6. Click Finish when you have completed the application. Please Note: This activity does not submit the form to the IRB Office.
  7. 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.