A protocol deviation or violation is any departure from the study procedures or treatment plans as specified in the IRB-approved protocol. Protocol deviations occur when an investigator does not ...

Follow the step-by-step instructions below to successfully maintain and close a protocol with the IRB. Instructions below include information about continuing reviews, amendments, event reporting (new ...

The Clinical Research Unit (CRU) is committed to providing investigators and their teams a research environment and broad range of services guided by good clinical practice. This contributes to the ...