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Reporting Unanticipated Problems Human Subject Protection Updated February 2010
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). |
 
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Referring Patients
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Education
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IRB Publications Carle Regional EMS Systems Airlife Clinical Pastoral Education Contact a Regional Outreach Professional |
| Carle Clinic Association and Carle Foundation Hospital are separate business corporations that work together to provide quality care and services to their patients. Carle Clinic Association and Carle Foundation Hospital contract with insurance providers separately and may or may not choose to participate in all of the same insurance plans. Patients are urged to check with their carriers as to whether services are covered for either or both organizations. Copyright 2004, 2003, 2002 Carle Clinic Association and Carle Foundation Hospital. |
