Report Form

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Revised Policy Date

04/12/2023

Summary

The Report Form (RF) application is used to submit problems, events, or information issues to the IRB for review. These may include Adverse Events, Protocol Deviations, Reports of Non-Compliance, and Unanticipated Problems.

Related Documents

• Amendment Form

Related Research Topics

• Adverse Events
• Unanticipated Problems
• Deviations
• Adverse Device Effects
• Breaches of Confidentiality
• Report Forms
• PI Temporary Leave/Sabbatical, etc.

Related FAQs

• What are the possible consequences for deviating?
• What are the consequences for submitting a possible Unanticipated Problem late?
• What are the consequences for submitting possible non-compliance late?
• Should I submit an Amendment or a Report Form?
• Once my project is determined exempt, do I need to do anything else with the application?

Related Glossary Items

• Unanticipated Problem (UP)
• Serious non-compliance
• Continuing non-compliance
• Adverse Event (AE)

Type of Document

• Forms