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AE
An AE is a unique representation of a specific event used for medical
documentation and scientific analyses.
Adverse Event can be Physical signs and symptoms Abnormal laboratory values Changes in vital signs, physical examination, or on an electrocardiogram An increase in the frequency or intensity (worsening) of a condition or illness
Reporting and grading an AE simply reports that an event occurred and the seriousness of the event. The clinician must assign attribution of the event, either to the intervention or something else.
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Sources of AEs
All directly observed events Events discovered after questioning the subject Events spontaneously volunteered by the subject Laboratory, EKG or other test results
investigator brochure.
Unexpected as used in this definition, refers to an adverse experience that has
not been previously observed( included in the investigator brochure) rather than
perspective of such experience not being anticipated from the pharmacological
An AE becomes serious when it: Results in Deaths Is life threatening i.e. subject at immediate risk of death from the reaction as it occurred e.g. anaphylactic shock (not allergic reaction)
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subjects ability to carry out normal life functions e.g. amputation of leg
Is a congenital anomaly or birth defect Is any other important medical events, based upon appropriate medical judgment, that may jeopardize the subject or may require medical or surgical intervention to prevent or avert one of the outcomes listed above
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Severity
Describes the intensity of the event e.g. mild, moderate, severe E.g. A severe headache may not be serious, a mild stroke resulting in disability is serious.
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Grades
Grade refers to the severity of the AE. The CTCAE (Common Terminology Criteria for Adverse Events) v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 : Mild AE
Grade 2 : Moderate AE
Grade 3 : Severe AE Grade 4 : Life-threatening or disabling AE Grade 5 : Death related to AE
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2. By Investigators:
Later in aggregate data review and reporting by the Investigators.
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Attribution Standards 1.Unrelated: The Adverse Event is clearly not related to the investigational agent(s) 2.Unlikely: The Adverse Event is doubtfully related to the investigational agent(s) 3.Possible: The Adverse Event may be related to the investigational agent(s) 4.Probable: The Adverse Event is likely related to the investigational agent(s) 5.Definite: The Adverse Event is clearly related to the investigational agent(s)
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Sponsors Responsibilities
Expedited the reporting of all serious, unexpected ADR to all concerned Investigators, Regulatory Authority and Ethics Committee
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Any adverse experience associated with the use of the drug and is serious and
unexpected within 15 days of the sponsors initial receipt of the information Any unexpected fatal or life threatening within 7 calendar days Unanticipated adverse device effects ---within 10 working days For post-market drug
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Differences between clinical practice and clinical trials when reporting adverse
events
All investigators working within investigational drug must be informed of any event with the drug that is serious, related and unexpected Investigator must inform the IRB of any IND safety reports Protocols should contain explicit directions for collecting, assessing and reporting
adverse events
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