Unexpected Adverse Event - (correct answer) adverse
reaction, the nature or severity of which is not consistent
with the applicable product information
Adverse Event - (correct answer) - any
unfavourable/unintended change
- no causal relationship needed
- may occur during or after administration of the
investigational product
Adverse drug reaction (before market approval) -
(correct answer) unintended response related to any
done
-must have probable cause`
Investigator must report all SAEs within _____ to
sponsors
-if life threatening: - (correct answer) 24 hours
,-immediately
sponsor duty for SAEs - (correct answer) report to
SUSARs
In ICH E6, what is the difference between an adverse
event (AE) and adverse drug reaction (ADR)?
- There is no difference.
- An adverse drug reaction is related to individual
subjects in a study while an adverse event is related to
groups of subjects in a study.
- An adverse event is reported in a clinical trial and an
adverse drug reaction is the term used in pre-clinical
research. - An adverse drug reaction is a response to the
investigational product and an adverse event may or may
not be a response to the investigational product. -
(correct answer) An adverse drug reaction is a response
to the investigational product and an adverse event may
or may not be a response to the investigational product.
, A study subject reports that he has been having
headaches for years but they seem to have become more
frequent since starting the study. The investigator
believes this is not related to the study medication. How
would a clinical research coordinator document this
event?
- This event would be an adverse event because the
complaint is more frequent headaches since starting the
study.
- This event would be a serious adverse event because
the subject is taking part in a research study.
- This event does not require documentation because it is
part of the study subject's medical history.
- This event would not be considered an adverse event,
but it would be noted in the subject's medical history
form. - (correct answer) This event would be an
adverse event because the complaint is more frequent
headaches since starting the study.
Subject 311 has had elevated white blood cell (WBC)
counts for the past two (2) study visits, with no clinical
signs or symptoms. "Increased WBC count" is not listed
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