Case reports and signals

Pharmacovigilance gathers reports of suspected adverse events on a medicine from many sources, processes each one as an individual case, and looks across the cases for signals of a new risk, which may end in regulatory action and a safety communication. This branch covers that path from a single report to a signal, and its parts divide by the step the work concerns: where the safety information comes from and the database it feeds, the validation, categorisation and reporting of one case, and the management of a signal from its detection to the actions that answer it. It leaves the aggregate reports built from these cases to periodic safety reports, the safety concerns and the measures that minimise them to risk management, and safety reporting inside a trial to safety reporting during a clinical trial.

• Where the safety information comes from — the sources a pharmacovigilance document draws on, from clinical studies, the literature and spontaneous reports with the schemes that collect them to registries, patient support programmes, marketing studies and medication errors, and the safety database they feed and the quality of its data
• Individual case safety reports — what makes a report a valid case, whether the product is the company's, the role of each medicine the patient took, the reporter, what counts as an adverse event, seriousness, causality and expectedness against the reference safety information, day zero and the reporting timelines, the international format of the report, the EudraVigilance system that receives it and who can see the reports there, and what individual case reports make possible
• Running a signal from detection to risk communication — what a signal is and how products are monitored for one, signal management as a legal duty in the EU, a signal's detection, validation and assessment and the recommendations for action once it is confirmed, signals in the aggregate reports, the regulatory actions taken on authorised medicines and the management of incidents with a serious impact on public health, the exchange of safety information between agencies, and automating case processing and signal detection