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Glossary Term

Approval With Modifications (Stipulations)

Review & Determinations

Also known as: approval with stipulations, approvable with modifications, stipulations

An IRB determination that a study is approvable contingent on specific changes the investigator must implement.

When the IRB requires modifications, the investigator submits revisions that are typically verified by the Chair or designee under expedited authority. Final approval is only effective once the modifications are accepted.

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