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Filing an Adverse Event (AE) or Other Reportable Information or Occurrence (ORIO) [PSC]

a PSC Data Resource

Resource Source:Population Studies Center

Abstract

This document describes how to file an AE/ORIO. An example of an ORIO is reporting an inspection visit. Another would be to address an expired IRB. A separate document will cover this issue.

Link:

AE/ORIO (Source: Population Studies Center)

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