November 2024 SOCRA Source Journal - Journal - Page 54
and should be reported to
the Sponsor.
In terms of safety reporting (21
CFR 312.32(a)), FDA de昀椀nes
SAEs as those that, in the view
of either the Investigator or
Sponsor, result in any of the
following outcomes:
•
•
•
•
•
•
Death
Place the subject at
immediate risk of death
(i.e., life-threatening)
Inpatient hospitalization
or prolongation of existing
hospitalization
Persistent or signi昀椀cant
incapacity or substantial
disruption of the ability to
conduct normal life functions
Congenital anomaly/birth
defect or
Important medical events (as
determined by clinician) that
may jeopardize the subject
and may require medical
or surgical intervention to
prevent outcomes listed
above
Table 6 provides an overview of
AE severity.
In terms of grading, non-oncology
and device studies often use a
5-point mild, moderate, severe,
life-threatening, death scale,
based on signs, symptoms, and
the effect on activities of daily
living (ADLs).
For oncology studies, UAMS most
often utilizes the NCI Common
Terminology Criteria for Adverse
Events (CTCAE) grading scale,
which breaks down conditions
by system organ class, term and
grade, strati昀椀ed from least to
most severe (i.e., Grades 1–5).
TABLE 6
AE Severity
•
Severity: “Intensity of an event; based on investigator’s
clinical judgement”
•
Grading scales:
o Non-oncology and device studies often use a mild,
moderate, severe, life-threatening, death scale, based on
signs and symptoms and effect on activities of daily living
(ADLs)
Grades:
o Grade 1: Mild:
- Easily tolerated, minimal discomfort, not interfering
with ADLs
o Grade 2: Moderate:
- Suf昀椀ciently discomforting to interfere with ADLs
o Grade 3: Severe:
- Prevents normal ADLs
o Grade 4: Life-Threatening:
- Speci昀椀c parameters according to the organ
system involved
o Grade 5: Death
•
•
Oncology studies often use the NCI Common Terminology
Criteria for Adverse Events (CTCAE):
o System Organ Class
o Term
o Grade
- Grade 1: Asymptomatic or mild symptoms;
no intervention indicated
- Grade 2: Minimal, local or non-invasive intervention
indicated
- Grade 3: Medically signi昀椀cant but not immediately
life-threatening
- Grade 4: Life-threatening consequences; urgent
intervention indicated
- Grade 5: Death
All AEs must be assessed for
their relationship to study
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