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Glossary Term

Continuing Review

Periodic re-review of an ongoing study by the IRB to confirm that risks remain minimized and protections remain adequate.

Continuing review must occur at least annually for studies that exceed minimal risk, though the 2018 Common Rule eliminated mandatory continuing review for many minimal-risk and post-enrollment studies. FDA-regulated studies still require continuing review at intervals appropriate to the degree of risk, at least annually.

During continuing review, the IRB assesses enrollment, adverse events, new information, consent currency, and any unanticipated problems.

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