MEGA SOCRA CCRP EXAM CONTENT
STUDY GUIDE (Combining multiple sets from other
sources including ACRP Actual Content) NEWEST
ACTUAL EXAM QUESTIONS BANK / 750+ COMPLETE
ACCURATE QUIZZES WITH DETAILED VERIFIED
ANSWERS / 2025
Terms in this set (790)
5 The minimum number of IRB members
Subjects cannot be enrolled In a non-emergency situation, under which of the
until IRB/IEC approval has following conditions, if any, may subjects be enrolled into
been obtained a study prior to IRB/IEC approval?
The Sponsor The responsibility for ensuring that the investigator understands a
clinical trial lies with:
This subject should undergo all study procedures as outlined in the
protocol
A subject has been enrolled
on a study and was
randomized to the non-
treatment arm. The
protocol outlines study
procedures for all subjects
to be performed within one
week of enrollment. Which
of the following statements
about this case is correct?
, a. Intended as an implant and presents a potential
forserious risk to the health, safety, or welfare of a subject.
b. Purported or represented to be for a use insupporting
or sustaining human life and presents a potential risk to
the health, safety, or welfare of a subject.
c. For a use of substantial importance in diagnosing,curing,
mitigating, or treating disease, or otherwise preventing
impairment of human health and presents a potential for
serious risk to the health, safety, or welfare of a subject.
A significant risk device is
defined as an investigational
device that is:
With respect to IRB/IEC At least one member's primary area of interest is in a nonscientific
membership, both the FDA area
and the ICH require that
The rights, safety, and well- A purpose of monitoring clinical trials is to verify that:
being of human subjects are
protected
Which of the following is Add the initials of the person making the change, the date of
the proper way to make a the change, and, if necessary, a brief explanation of the
correction to a CRF? change.
What details need to be A. The severity of the event
documented in the subject B. When the event occurred
source documentation when
C. Setting in which the event occurred
an Adverse Event (AE)
occurs? Select all that apply
What is an Unexpected A reaction that is not consistent with the applicable product
Adverse drug reaction? information
,The terms "serious" and FALSE
"severe" are synonymous
according to ICH.
A serious adverse event is A. Results in death
any untoward medical B. Is life-threatening
occurrence which at any C. Is a congenital anomaly
dose is best described by
which of the following
statements?
Select all that apply
. Which of the following The Intensity of a specific event
options describes the term
"severe" in regards to
ICH?
Serious Adverse Drug Reaction
Subject 3826 had to stay in
the hospital for three extra
days when his legs started
swelling after participation
in a cardiac drug study.
Swelling of the legs was
listed in the Investigator's
Brochure as a possible side
effect. Which of the
following options best
describes this situation?
, A subject in your diabetes FALSE
research study developed
colon cancer, which the
Investigator has determined
to be unrelated to the study.
The subject is currently
asymptomatic. This will be
considered a serious adverse
event because it
is life threatening. Is this a
true or false statement?
In pre-market approval Adverse Drug Reaction
studies, all noxious and
unintended responses to a
medicinal product, even
possibly related to any dose,
should be considered which
of the following options?
1. A de-identified autopsy report, if available
A subject has a suspected 2. Cause of death, and a comment on its possiblerelationship to the
serious adverse drug suspected drug reaction
reaction with the outcome
of death. Per the ICH E2A
guideline, which are items
that should be submitted to
the Sponsor?
STUDY GUIDE (Combining multiple sets from other
sources including ACRP Actual Content) NEWEST
ACTUAL EXAM QUESTIONS BANK / 750+ COMPLETE
ACCURATE QUIZZES WITH DETAILED VERIFIED
ANSWERS / 2025
Terms in this set (790)
5 The minimum number of IRB members
Subjects cannot be enrolled In a non-emergency situation, under which of the
until IRB/IEC approval has following conditions, if any, may subjects be enrolled into
been obtained a study prior to IRB/IEC approval?
The Sponsor The responsibility for ensuring that the investigator understands a
clinical trial lies with:
This subject should undergo all study procedures as outlined in the
protocol
A subject has been enrolled
on a study and was
randomized to the non-
treatment arm. The
protocol outlines study
procedures for all subjects
to be performed within one
week of enrollment. Which
of the following statements
about this case is correct?
, a. Intended as an implant and presents a potential
forserious risk to the health, safety, or welfare of a subject.
b. Purported or represented to be for a use insupporting
or sustaining human life and presents a potential risk to
the health, safety, or welfare of a subject.
c. For a use of substantial importance in diagnosing,curing,
mitigating, or treating disease, or otherwise preventing
impairment of human health and presents a potential for
serious risk to the health, safety, or welfare of a subject.
A significant risk device is
defined as an investigational
device that is:
With respect to IRB/IEC At least one member's primary area of interest is in a nonscientific
membership, both the FDA area
and the ICH require that
The rights, safety, and well- A purpose of monitoring clinical trials is to verify that:
being of human subjects are
protected
Which of the following is Add the initials of the person making the change, the date of
the proper way to make a the change, and, if necessary, a brief explanation of the
correction to a CRF? change.
What details need to be A. The severity of the event
documented in the subject B. When the event occurred
source documentation when
C. Setting in which the event occurred
an Adverse Event (AE)
occurs? Select all that apply
What is an Unexpected A reaction that is not consistent with the applicable product
Adverse drug reaction? information
,The terms "serious" and FALSE
"severe" are synonymous
according to ICH.
A serious adverse event is A. Results in death
any untoward medical B. Is life-threatening
occurrence which at any C. Is a congenital anomaly
dose is best described by
which of the following
statements?
Select all that apply
. Which of the following The Intensity of a specific event
options describes the term
"severe" in regards to
ICH?
Serious Adverse Drug Reaction
Subject 3826 had to stay in
the hospital for three extra
days when his legs started
swelling after participation
in a cardiac drug study.
Swelling of the legs was
listed in the Investigator's
Brochure as a possible side
effect. Which of the
following options best
describes this situation?
, A subject in your diabetes FALSE
research study developed
colon cancer, which the
Investigator has determined
to be unrelated to the study.
The subject is currently
asymptomatic. This will be
considered a serious adverse
event because it
is life threatening. Is this a
true or false statement?
In pre-market approval Adverse Drug Reaction
studies, all noxious and
unintended responses to a
medicinal product, even
possibly related to any dose,
should be considered which
of the following options?
1. A de-identified autopsy report, if available
A subject has a suspected 2. Cause of death, and a comment on its possiblerelationship to the
serious adverse drug suspected drug reaction
reaction with the outcome
of death. Per the ICH E2A
guideline, which are items
that should be submitted to
the Sponsor?
