While important, clinical trial protocols merely provide the foundation for success. It is the people who run those protocols, and their use of optimal processes and systems, that determine whether ...

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 Principal Investigator (PI) is responsible for reviewing this policy and complying with its requirements. Specifically, the PI will: You may use the protocol template to record your information ...

All submissions requiring IACUC review are assigned for review as they are received. Most protocols are reviewed and approved via designated member review (DMR), which allows approval once all review ...

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 ...