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Your First Application to the GCRC
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Adverse Events: Definition and Grading
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory
finding), symptom or disease temporally associated with the use of a medical treatment or
procedure regardless of whether it is considered related to the medical treatment or procedure.
This includes all deaths that occur while a subject is on a study.
| Adverse Event Grade |
Definition |
| Serious |
Any adverse event occurring at any dose that results in any of the following outcomes:
death, a life-threatening adverse event (see below), requires inpatient hospitalization
or prolongation of existing hospitalization, a persistent or significant
disability/incapacity, or a congenital anomaly/birth defect.
Important medical events that may not result in the previous outcomes may be considered
a serious adverse drug experience when, based upon appropriate medical judgment, they
may jeopardize the patient or subject and may require medical or surgical intervention
to prevent one of the outcomes listed in this definition.
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| *Life-threatening |
An experience that in the opinion of the Investigator places the subject at immediate
risk of death from the reaction as it occurred, i.e., it does not include a reaction
that, had it occurred in a more severe form, might have caused death.
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| Other |
Any adverse experience that does not meet the definition of serious. Non-serious
adverse experiences can be classified as:
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| Mild |
An experience that is usually transient, & requires no special treatment or
intervention. The experience does not generally interfere with usual daily
activities. Includes transient laboratory test alterations
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| Moderate |
An experience that is alleviated with simple therapeutic treatments. The experience
impacts usual daily activities. Includes laboratory test alterations indicating
injury, but without long-term risk.
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| Severe |
An experience that requires therapeutic intervention. The experience interrupts usual
daily activities. If hospitalization is required for treatment it becomes a serious
adverse event.
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Unexpected/Expected Adverse Drug Events:
| Event Grade |
Definition |
| Unexpected |
Any adverse experience, the nature, severity or frequency of which is not consistent
with the current investigator brochure; or with the risk information described in the
investigational plan or protocol or consent form. Unexpected refers to an experience
that has not been previously observed. This includes events that are more serious
than expected or occur more frequently than expected.
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| Expected |
Those experiences that have been identified in nature, severity, or frequency in the
current investigator brochure, investigational plan/protocol and current consent form.
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