IX.B.2. Signal detection

Signal detection should follow a methodology which takes into account the nature of data and the characteristics (e.g. time on market, patient exposure, target population) as well as the type of medicinal product concerned (e.g. vaccines and biological medicinal products may for example require specific methodological strategies (see GVP P.I. and GVP P.II.)). Data from all appropriate sources should be considered (see IX.B.1.). Clinical judgement should always be applied.

Signal detection may involve a review of ICSRs, statistical analyses, or a combination of both, depending on the size of the data set. When it is not relevant or feasible to assess each individual case (e.g. signals detected from published studies, healthcare record data), assessment of aggregated data should be considered.

Guidance on statistical aspects of signal detection may be found in GVP Module IX Add I.

The signal detection process should be adequately documented by each organisation (see IX.B.5.).