Serious Adverse Events (SAEs) must be reported immediately to the sponsor. The sponsor then assesses the severity, causality, and potential impact on the study and decides whether further reporting to regulatory authorities and IRB/IEC is required. Immediate reporting ensures that appropriate actions are taken to safeguard participant safety.

GCP guidelines specify that the site must notify the sponsor immediately about any SAE to ensure timely safety assessment and reporting.

"Sites must report all serious adverse events immediately to the sponsor, who will then determine the appropriate regulatory and ethical reporting requirements."

Objectives:

Ensure rapid reporting of serious adverse events.

Maintain safety monitoring during the trial.