Report Safety/Compliance Events
The sequence of IRB activities for your study
APPLY for IRB approval
MODIFY the approved study
RENEW your IRB approval
REPORT events and new information ←
CLOSE your IRB application
What you should have already completed
- Determine that the event or new information requires reporting to the IRB. See this list that describes reportable events and information.
Required skills and tools
- The same as for APPLY.
The parts of your Report New Information (RNI) application
|RNI Supplement required, depending on what is being reported
This is a Word document that you complete and upload to Zipline. Any additional documents, as appropriate for the situation required
Some common examples:
Zipline SmartForms required
What to do: The first step
Determine whether you need to upload a completed RNI Supplement. It is required if your report involves noncompliance or a problem or event related to a subject. You can look at the RNI Supplement form and decide whether it makes sense with respect to what you are reporting.
What to do: Other steps
- Complete the RNI Supplement if appropriate.
- Prepare any other documents for uploading.
- Create any documents that do not already exist. For example, if your report requires a lengthy description of something, you may wish to provide that information as an uploaded document rather than a long answer to a question on the RNI Supplement.
- Label electronic documents with a title, date and version number. A footer in the document is usually the best place for this information.
- Give each electronic document a unique and descriptive name to help distinguish them in Zipline.
- Redact any identifiable subject information.
- Create the Zipline part of your Report application. Log into Zipline and click on Report New Information. Answer the questions, and follow instructions about uploading the RNI Supplement (if needed) and other documents you have prepared.
- Check your application for completeness, by using the Hide/Show Errors activity.
- Submit your application to HSD. Anyone can prepare and submit the RNI – not just the PI or PI Proxy. The RNI Submitter should be the person who will communicate with the IRB about the issue. Click on Submit then click on OK.
- Submit a related modification, if appropriate. It may be appropriate or required to modify your study because of the new information you’ve submitted as a RNI. Examples: New risk information needs to be put into the consent form; repeated noncompliance with a study procedure means that the process for conducting the procedure needs to be modified. Be sure to identify the Modification as being related to your RNI application.
What to expect after submitting
An HSD staff member will be assigned to your application, usually within one business day. You will receive an email notice if additional information is needed and also to inform you about the outcome of the IRB’s review. The ongoing status of your modification is displayed in the workflow graphic at the top of the RNI workspace in Zipline.
Three common, high-impact mistakes (and how to prevent them)
- Not reporting information or events that are required to be reported.
Prevention: Become familiar with the list of events, problems, and new information that must be reported to the IRB.
- Not associating related modifications to the RNI.
Prevention: Create and submit the modification in Zipline first, then create the RNI and associate both the study and the modification where prompted. You will need to add the study first, followed by the specific modification. If you submit an RNI-related modification after already submitting your RNI, reference the RNI number in the modification when summarizing the changes and submit a Zipline comment in the RNI alerting the assigned IRB coordinator.
- Identifiable subject information is provided in the RNI.
Prevention: Identifiable subject information should never be provided in a Report, or in any part of your IRB application. Use pseudonyms, study ID numbers, or name placeholders in reports. Redact all identifiable subject information in any documents you upload. If identifiable information must be provided, send the information via encrypted email to firstname.lastname@example.org. Be sure to reference the RNI number (e.g. RNI00001234) in the subject line.
Ask for help
Send an email to email@example.com if you have questions or need help. Identify your department in your email.
- Researcher Guide, especially the Reports of New Information section