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The Life of a Protocol

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

New to Human Subjects Research? Start Here!

A helpful page for students and other first time investigators

Roles & Responsibilities

A description of the research team roles and their responsibilities 

Initial Application

Explains what is needed for an Initial Application

Amendment

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

Continuing Review

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

Event Reporting (New Information)

Explains what events need to be reported to the IRB

Closing a Study

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

Response

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

Check Status

Explains how to check the status of a submission in eRA

 

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