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 following steps were used to achieve the objectives: Central Support: A central PSPO office was established with minimal required staffing for provision of support to clinicians for protocol ...