MEGA SOCRA CCRP EXAM
CONTENT TEST WITH
COMPLETE VERIFIED
SOLUTIONS
5
The minimum number of IRB members
Subjects cannot be enrolled until IRB/IEC approval has been obtained
In a non-emergency situation, under which of the following conditions, if
any, may subjects be enrolled into a study prior to IRB/IEC approval?
The Sponsor
The responsibility for ensuring that the investigator understands a clinical
trial lies with:
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?
This subject should undergo all study procedures as outlined in the
protocol
A significant risk device is defined as an investigational device that is:
a. Intended as an implant and presents a potential for serious risk to the
health, safety, or welfare of a subject.
b. Purported or represented to be for a use in supporting 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.
With respect to IRB/IEC membership, both the FDA and the ICH require
that
, At least one member's primary area of interest is in a nonscientific area
The rights, safety, and well-being of human subjects are protected
A purpose of monitoring clinical trials is to verify that:
Which of the following is the proper way to make a correction to a CRF?
Add the initials of the person making the change, the date of the change,
and, if necessary, a brief explanation of the change.
What details need to be documented in the subject source documentation
when an Adverse Event (AE) occurs? Select all that apply
A. The severity of the event
B. When the event occurred
C. Setting in which the event occurred
What is an Unexpected Adverse drug reaction?
A reaction that is not consistent with the applicable product information
The terms "serious" and "severe" are synonymous according to ICH.
FALSE
A serious adverse event is any untoward medical occurrence which at any
dose is best described by which of the following statements?
Select all that apply
A. Results in death
B. Is life-threatening
C. Is a congenital anomaly
. Which of the following options describes the term "severe" in regards to
ICH?
The Intensity of a specific event
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?
Serious Adverse Drug Reaction
A subject in your diabetes 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?
FALSE
CONTENT TEST WITH
COMPLETE VERIFIED
SOLUTIONS
5
The minimum number of IRB members
Subjects cannot be enrolled until IRB/IEC approval has been obtained
In a non-emergency situation, under which of the following conditions, if
any, may subjects be enrolled into a study prior to IRB/IEC approval?
The Sponsor
The responsibility for ensuring that the investigator understands a clinical
trial lies with:
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?
This subject should undergo all study procedures as outlined in the
protocol
A significant risk device is defined as an investigational device that is:
a. Intended as an implant and presents a potential for serious risk to the
health, safety, or welfare of a subject.
b. Purported or represented to be for a use in supporting 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.
With respect to IRB/IEC membership, both the FDA and the ICH require
that
, At least one member's primary area of interest is in a nonscientific area
The rights, safety, and well-being of human subjects are protected
A purpose of monitoring clinical trials is to verify that:
Which of the following is the proper way to make a correction to a CRF?
Add the initials of the person making the change, the date of the change,
and, if necessary, a brief explanation of the change.
What details need to be documented in the subject source documentation
when an Adverse Event (AE) occurs? Select all that apply
A. The severity of the event
B. When the event occurred
C. Setting in which the event occurred
What is an Unexpected Adverse drug reaction?
A reaction that is not consistent with the applicable product information
The terms "serious" and "severe" are synonymous according to ICH.
FALSE
A serious adverse event is any untoward medical occurrence which at any
dose is best described by which of the following statements?
Select all that apply
A. Results in death
B. Is life-threatening
C. Is a congenital anomaly
. Which of the following options describes the term "severe" in regards to
ICH?
The Intensity of a specific event
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?
Serious Adverse Drug Reaction
A subject in your diabetes 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?
FALSE
