Noncompliance
Study teams are responsible for reporting noncompliance to the IRB/ORA. This page serves as a guide for study teams when deciding what constitutes noncompliance, when it needs to be reported, and how to report it.
The following Noncompliance Guide will explain what events require prompt reporting to the IRB/ORA, what to do when there is a planned protocol deviation, steps on how and when to submit an incident report, and how to handle non-compliance for a central IRB (cIRB) study.
The following Corrective Action Plan (CAP) Guide will assist study teams with writing a thorough, robust CAP.
The following Noncompliance Root Cause Analysis and Corrective Action Plans document is a detailed guide on what constitutes noncompliance and reporting noncompliance. It also provides guidance on analyzing an incident, including a proper root cause analysis, and developing and writing a clear and thoughtful Corrective Action Plan (CAP).