Serious or continuing non-compliance must be reported promptly to OHRP/FDA, the institution, and the sponsor as applicable. The IRB evaluates whether suspension, additional safeguards, or other corrective actions are required.
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Glossary Term
Serious Non-Compliance
Review & Determinations
Also known as: serious non-compliance, continuing non-compliance, serious noncompliance
A material failure to follow regulations, IRB requirements, or the approved protocol that increases risk to subjects or affects their rights or welfare.
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