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  2. Examples of Solicited Reports Sources: Clinical Trials: Data collected from participants during a clinical trial, including both efficacy and safety data. Post-Marketing Surveillance Studies (Phase IV Trials): Studies conducted after a drug is approved and marketed, aimed at understanding long-term safety and effectiveness.
    www.pharmacovigilanceanalytics.com/glossary/solicited-reports/
    www.pharmacovigilanceanalytics.com/glossary/solicited-reports/
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    Should unsolicited cases of adverse reactions be reported as spontaneous reports?Unsolicited cases of suspected adverse reactions from the internet or digital media should be handled as spontaneous reports. The same reporting time frames as for spontaneous reports should be applied (see VI.B.7.).
    What is a spontaneous report?A spontaneous report is an unsolicited notification that describes one or more suspected adverse events in a patient who was given one or more medicinal products and does not derive from a study or any organized data collection systems where adverse event reporting is actively sought.
    Who should collect and collate reports of adverse reactions originating from unsolicited sources?Competent authorities and marketing authorisation holders should take appropriate measures in order to collect and collate all reports of suspected adverse reactions associated with medicinal products for human use originating from unsolicited or solicited sources.
    What is the difference between a spontaneous and a solicited report?These reports differ from spontaneous reports, which are unsolicited and initiated by healthcare professionals, patients, or caregivers based on observations in routine clinical practice. Structured Data Collection: Solicited reports are gathered through organized and planned data collection systems.
     
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    WebNov 1, 2023 · Whether you want to track the progress of your strategies or stay compliant with financial laws, there is a different report for each task. To help you identify when to use them, we will cover the top 14 most …

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