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May 2022 Update

UUSOP-14: Clinical Trial Safety Assessment and Reporting

The assessment and accurate reporting of safety events is critical to the conduct of a clinical study and helps to ensure the safety of research participants. UUSOP-14 describes the requirements for collecting, evaluating, documenting and reporting safety events such as Adverse Events (AE), Serious Adverse Events (SAE), Unanticipated Problems (UP), and other safety events that can occur during the course of a clinical trial.

Safety events should be collected and reported according to the study protocol and the requirements described in UUSOP-14, as applicable.

The Principal Investigator (PI) is ultimately responsible for the overall conduct of the trial, including the protection of research participant rights, safety, and welfare, and ensuring that an investigation is conducted in accordance with the protocol, Good Clinical Practice (GCP), Institutional Review Board (IRB), Food and Drug Administration (FDA) and all other applicable regulations


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Last Updated: 12/13/23