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REFERRING PATIENTS TO CARLE FOUNDATION HOSPITAL

EDUCATION
CME
Level III Education Center
Trauma Recent Registry

GME/RESIDENCIES
Oral/Maxillofacial Surgery
Family Practice
UIUC-COM Internal Medicine
Geriatrics Fellowship

MEDICAL STAFF OFFICE/CREDENTIALING

REGIONAL OUTREACH OFFICE

INITIATING RESEARCH @ CFH

IRB

CARLE SELECTED PAPERS

CARLE REGIONAL EMS SYSTEMS

AIRLIFE

CLINICAL PASTORAL EDUCATION

 

Reporting Unanticipated Problems

HSPP

Updated April 2008

Research Home

 

Research Office (FRO) Human Protection Tissue Repository

Initiating Research Scientific Rev Comm Deadlines

Institutional Rev Board IRBNet Forms & Templates

Links Policies/Procedures

 

Contact List/Staff Education Cost Research Review

Unanticipated Problem Submissions to IRB Clinical Trial Registry

Guidance Documents

  

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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