An Adverse Event of Special Interest (AESI) signifies a significant event associated with a specific product or category of products that a sponsor deems necessary to closely monitor. These events can be either serious or non-serious in nature (e.g., hair loss, loss of taste, impotence), and may encompass occurrences that could potentially serve as early indicators or warning signs of more severe medical conditions, particularly in susceptible individuals.
To ensure thorough oversight, these events are explicitly detailed within protocols or protocol amendments. Moreover, investigators are provided with explicit guidance on how and when to report such events to the sponsor. By highlighting AESIs, sponsors aim to maintain a vigilant watch over potentially meaningful occurrences, striking a balance between rigorous monitoring and participant safety within the context of clinical trials.
Signal Management Process
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