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Reporting Unanticipated Problems HSPP Updated April 2008
Reporting Problems to the IRB UPIRSO/SAE All study related unanticipated problems posing a risk to subjects or others (UPIRSO) (whether or not the risk is actualized) must be reported to the IRB promptly. This includes unanticipated serious adverse events (SAEs) that are study related; and adverse events (AEs) that were anticipated but that occur at a greater frequency or with greater severity than anticipated. SAEs and AEs that are not study related and are not unanticipated should not be reported to the IRB except in summary form at continuing review.
Subject death All subject deaths in studies undertaken at Carle, whether or not related to the study, must be reported to the Carle IRB. In multi-center studies, if Carle is not the lead site and the death does not involve a Carle subject, the event does not need to be reported to the Carle IRB unless it represents a study related unanticipated problem (UPIRSO).
Continuing or serious non-compliance Under development
Failure of research integrity Under development
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Referring Patients
Physician Access Line
Education
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Initiating Research
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