What term describes the ongoing evaluation of an already approved study?

What term describes the ongoing evaluation of an already approved study?

• A. Amendment review
• B. Final review
• C. Continuing review
• D. Initial review

Answer: (C)

Continuing review is the term for ongoing oversight of an approved study. After the initial approval, the IRB or regulatory body re-evaluates the study at regular intervals to ensure risks to participants remain minimized, that new information hasn’t changed the risk/benefit balance, and that consent and other protections stay appropriate. This process keeps participant welfare at the forefront throughout the project, even as it progresses. It’s different from initial review, which happens before a study starts; amendment review, which covers proposed changes to the protocol; and final or closeout review, which occurs when the study is ending.

Continuing review is the term for ongoing oversight of an approved study. After the initial approval, the IRB or regulatory body re-evaluates the study at regular intervals to ensure risks to participants remain minimized, that new information hasn’t changed the risk/benefit balance, and that consent and other protections stay appropriate. This process keeps participant welfare at the forefront throughout the project, even as it progresses. It’s different from initial review, which happens before a study starts; amendment review, which covers proposed changes to the protocol; and final or closeout review, which occurs when the study is ending.