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Office of Human Research Ethics SOP 1402: IRB Review of Promptly Reportable Information
This SOP establishes written procedures for ensuring prompt review and reporting of any Unanticipated Problems Involving Risks to Subjects or Others, Serious Noncompliance, Continuing Noncompliance, Suspension or Termination of IRB approval.
Office of Human Research Ethics SOP 1401: Promptly Reportable Information
This SOP provides examples and procedures for the reporting of Promptly Reportable Information (PRI) to the University of North Carolina at Chapel Hill's Institutional Review Board.