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Potential Signal Vs Noise

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  • Manoj Swaminathan
    06/10/2019 14:50
    How does one differentiate between potential signal and noise? Unfortunately in quite a lot of companies, these terms are used synonymously, which is not really correct. A potential signal may find place in a PSUR while a noise may not.
  • Dominique Chesnais
    02/07/2020 12:00
    Authorities would expect that companies define them more as potential signals than too quickly and easily as background noise. As documented in GVP, Module IX – Signal management (Rev 1) https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-ix-signal-management-rev-1_en.pdf, section X.B.5. Quality requirements: “Signal management is considered a critical process… Through a tracking system, all organisations should keep an audit trail of signal management activities, allowing traceability (i.e. recording of dates and confirmation of timeliness) and process control of the details of all steps of signal management, including analyses, decisions and rationale. “ It is therefore better to assume them as potential signals, track and manage them as per procedures with all related documentation. To classify them as background noise would need some other justifications outside of the drug.
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