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Reporting Unanticipated Problems Human Subject Protection Updated June 29, 2011
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 reviewing IRB and the Human Protections Administrator (HPA) promptly [HPA for Carle Foundation is: Rebecca Morgan-Boyd]. 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. The HPA is responsible for following up on these reports as needed to meet the regulatory requirements.
Subject death All subject deaths in studies undertaken at Carle Foundation affiliates, 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). |
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