Signal Detection and management
A signal is data or information that may suggest a new causal association, or contribute new information about a known association, between a medicine and an adverse event that justifies further investigation. Signal detection is the process of identifying, as soon as possible, any suggestion that there may be an association between a medicine and a previously unrecognised adverse drug reaction (ADR) or a change in the frequency or severity of a known ADR.
A number of data sources are used for signal detection- information from spontaneous reporting systems, clinical trials, the scientific literature, pharmacoepidemiological studies, electronic medical records and health care databases. Detected signals are further evaluated by a team of drug safety experts to determine whether the signal actually does represent a real risk and requires further assessment, communication or risk minimisation actions in accordance with the medical importance of the signal.