Reporting Events
Unexpected problems involving risks to subjects or others, non-compliance, and participant complaints must be submitted to RCS and the IRB. For terminology, see our HSR definitions document.
Timelines
- Unless otherwise stated below (see FDA regulated studies section), events should be reported to RCS via the Research Administration Portal (RAP) no later than 7 days of the investigator becoming aware of the occurrence.
- However, investigators should contact Research Compliance Services (RCS) immediately upon discovery of an unanticipated problem or event involving risks to subjects or others.
FDA Regulated Studies
- Deviations from the Investigational Plan: The investigator must notify the sponsor, if applicable, and RCS/IRB of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency. The notice must be provided as soon as possible but no later than 5 working days after the emergency occurred.
- If it is not an emergency, prior approval from the IRB and the sponsor is required prior to making changes to the approved plan. Any non-compliance with this requirement must be reported within 7 days.
- For studies involving a significant risk medical device conducted under an IDE, the sponsor is also required to obtain FDA approval via supplemental application.
- Informed Consent Not Obtained: If an investigator uses an investigational device without obtaining informed consent, the investigator must report the use to the sponsor, if applicable and to the reviewing IRB/RCS within 5 working days.
- If the device/study is significant risk, the sponsor or sponsor-investigator must also report the event to the FDA within 5 working days of receiving notice that a device was used without informed consent.
- For studies not involving an investigational device, events can be submitted within 7 calendar days
- See the FDA's Guidance on Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices (2025) for more information about FDA specific requirements.
How to Submit
Use the RNI (Event) Reporting Form to report unanticipated problems, adverse events involving risks to participants or others, non-compliance and participant complaints to RCS/IRB for review. See the Report New Information (RNI) guidance on the RAP Guidance page for step-by-step directions on how to create and submit an RNI in the Research Administration Portal (RAP).
For additional information on unanticipated problems, please see the Federal guidance which can be found at the Office for Human Research Protections (OHRP) website.
If you have questions, please contact Research Compliance Services.