Preparing Protocol Submissions

The Life of a Protocol

A big-picture view of a IRB oversight of protocol from development to closure

A helpful page for students and other first time investigators

A description of the research team roles and their responsibilities

Explains what is needed for an Initial Application

Explains when an amendment is needed and what to submit to the IRB

Explains IRB approval/expiration dates and what to submit to the IRB for re-approval

Explains what events need to be reported to the IRB

Explains when a study is ready to be closed and how to do so

Explains the types of IRB determination that require an investigator to respond

Explains how to check the status of a submission in eRA