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Research Institute  :  Clinical Research Administration  :  Information for Investigators/Study Coordinators  :  Serious Adverse Event (SAE) Information

Serious Adverse Event (SAE) Definition


Good Clinical Practice (E6: 1.50)
ICH Guidelines define a serious adverse event (SAE) as:

"Any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization, or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect"

FDA's definition (21 CFR 312.32) is essentially the same, but continues:

"Important medical events that may not result in death, be life threatening, or require hospitalization may be considered a serious adverse experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require or surgical intervention to prevent one of the outcomes listed in this definition."

ICH Good Clinical Practice Reporting

4.11 Safety Reporting
    4.11.1 All serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate reports should be followed promptly by detailed, written reports. The immediate and follow-up reports should identify subjects by unique code numbers assigned to the trial subjects rather than by the subjects' names, personal identification numbers, and/or addresses. The investigator should also comply with the applicable regulatory requirement(s) related to the reporting of unexpected serious adverse drug reactions to the regulatory authority(ies) and the IRB/IEC.
    4.11.2 Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be reported to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in the protocol.
    4.11.3 For reported deaths, the investigator should supply the sponsor and the IRB/IEC with any additional requested information (e.g., autopsy reports and terminal medical reports).
This page last updated: September, 06, 2008