Reporting Incidents and Violations

Please review SOP 901: Unanticipated Problems Involving Risks to Participants or Others and SOP 902: Deviations to determine whether your incident requires reporting to the RIRC.

In general, an incident that is reportable to the RIRC if it is a/an:

• Protocol deviation which meets one or more of the following criteria:
  • Intended to eliminate apparent immediate hazard to a research participant; or
  • Caused possible harm to participants or others, or placed them at increased risk of harm- including physical, psychological, economic, or social harm); or
  • Possible serious or continued noncompliance
• Unanticipated problem involving risks to participants and others, including unexpected and related or serious adverse events

If the incident is reportable, please submit an Incident report through Human Ethics. Below is a guide to explain how to submit an Incident report for your approved study.

1. Click https://queens.app.cayuse.com to log in
2. Navigate to the Human Ethics portal
3. Click on the study you would like to Report an Incident.
4. In the upper right-hand corner, click blue button +”Incident”
5. Select Edit.
6. Complete the Incident report as indicated.
   • Some incidents may require a follow-up report. Please submit a new Incident report but refer to the previous Incident report when completing the follow-up.
7. Once complete, mark the routing button as “Complete Submission”
8. The Principal Investigator will receive a notice to “Certify” the submission.
9. Once the principal investigator certifies, the submission will be received by the RRO and will undergo review.