August 2024 SOCRA Source Journal - Journal - Page 41
TABLE 6
AEs and SAEs
•
AE de昀椀nition:
o ICH GCP E6:
o
FDA 21 CFR 314.80:
o
Any adverse event associated with the use of a drug in humans,
whether or not considered related
Things that are not AEs:
•
Any untoward medical occurrence in a patient administered a pharmaceutical
product and which does not necessarily have a causal relationship with the treatment
Endpoints, which should be reported as directed in the protocol
Disease progression
SAE de昀椀nition:
o An AE is considered serious, if in the investigator’s or sponsor’s judgment,
it results in one of the following outcomes:
-
Death:
-
-
Report if the AE resulted in admission to the hospital or prolongation
of hospitalization
Evaluate emergency room visits that do not result in hospital admission
for other serious outcomes
Persistent or signi昀椀cant disability/incapacity:
Report if the AE resulted in a substantial disruption of a person’s
normal life functions
Congenital anomaly or birth defect:
-
Report the patient was at substantial risk of dying at the time of the event
Hospitalization (initial or prolonged):
-
Include the date if known
Life-threatening:
-
Report if death is suspected to be an outcome of an AE
Report if exposure to a medicinal product prior to conception or
during pregnancy is suspected to have resulted in an adverse
outcome in the child
Other serious (important medical) events:
Report when the event does not 昀椀t the other outcomes, but the
event may jeopardize the patient and may require medical or
surgical intervention to prevent another outcome
SOCRA SOURCE © May 2024
41