Submissions | Human Research Protection Program (HRPP)

As your study progresses, submit the following to the IRB as needed:

Submission Type	Guidance
📑 New Study	After confirming that your research requires IRB review.
🛠️ Modification	Any changes to your study must be approved by the IRB before implementation.
📆 Continuing Review	A periodic progress report required for certain studies.
💊 Research involving Drugs	An overview of regulatory and submission requirements for projects involving drugs
🔬 Research involving Devices	An overview of regulatory and submission requirements for projects involving devices.
🚨 Emergency Use & Compassionate Use	For experimental drugs or devices used in urgent or compassionate circumstances.
🔐 Expanded Access to Unapproved Drugs for Treatment	Overview of the sponsor and FDA requirements needed to approve the use of an investigational drug for an individual patient or group.
📋 Reportable New Information (RNI): Adverse Events, Protocol Violations, or Safety Reports	Submit if it meet IRB reporting requirements.
🔒 Closing Your Study	Required when the study is complete.
⏳ Study Expiration & Extended Approval	Ensure compliance with IRB requirements.