Safety Signal

A safety signal is an information that suggests a potential new safety issue or an increased frequency or severity of a known adverse event associated with a particular drug or medical product. Safety signals are detected through various sources, including spontaneous reporting systems, clinical trials, post-marketing surveillance, literature reviews, and other sources of safety data.

When a safety signal is identified, it triggers further investigation and evaluation to determine the validity and clinical significance of the signal. This process involves rigorous analysis of available data, including individual case reports, aggregate safety data, and epidemiological studies, to assess the strength and potential causality of the signal.