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- You must submit all required study closure materials via NIH electronic IRB system using the Modification/Continuing Review (CR) form.
- Unless a new Principal Investigator (PI) is named, a study must be closed if the current PI is leaving the NIH.
- Once the protocol is closed, all research activities will cease.
- Once the study is closed, any analyses using the identifiable private information or identifiable biospecimens from the study, will require prospective IRB review and approval.
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- Studies for which CR is required: Submit the Modification/CR Form no later than the expiration date of the study.
- Studies for which CR is not a requirement: Submit the Modification/CR Form when all human subjects research activities are complete.
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