New discussion: PhV in medical research - XXIX

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Dear members, Lets see about spontaneous reports and solicited reports.Spontaneous ReportsA spontaneous report is an unsolicited communication by a healthcare professional or consumer to a company, regulatory authority or other organization (e.g. WHO, Regional Center, Poison Control Center) that describes one or more adverse drug reactions in a

patient who was given one or more medicinal products and that does not derive from a study or any organized data collection scheme.Consumer adverse reaction reports should be handled as spontaneous reports irrespective of any subsequent “medical confirmationâ€. Regulatory Authorities might require medical confirmation for the purpose of expedited reporting. Emphasis should be placed on the quality of the report and not on its source. Even if reports received from consumers do not qualify for regulatory reporting, the cases should be retained Solicited reports (Study reports) Solicited reports are those derived from organized data collection systems, which include clinical trials, registries, post-approval named patient use programs, other patient support and disease management programs, surveys of patients or healthcare providers, or information gathering on efficacy or patient compliance. Adverse event reports obtained from any of these should not be considered spontaneousRegards,Dr. Vijay M. katekhayePostgraduate StudentDept. of Pharmacology,LTMMC & LTMGH, Sion,Mumbai - 400 022 Ph - +919619313060