MEGA SOCRA CCRP EXAM CONTENT with
complete updated questions & answers
5 - answer The minimum number of IRB members
Subjects cannot be enrolled until IRB/IEC approval has been obtained -
answer 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 - answer 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? - answer This subject should
undergo all study procedures as outlined in the protocol
A significant risk device is defined as an investigational device that is: -
answer 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 - answer 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 -
answer 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?
- answer 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 - answer 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? - answer A reaction that
is not consistent with the applicable product information
The terms "serious" and "severe" are synonymous according to ICH. -
answer 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 - answer 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? - answer 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? -
answer 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? - answer FALSE
In pre-market approval studies, all noxious and unintended responses
to a medicinal product, even possibly related to any dose, should be
considered which of the following options? - answer Adverse Drug
Reaction
A subject has a suspected serious adverse drug reaction with the
outcome of death. Per the ICH E2A guideline, which are items that
should be submitted to the Sponsor? - answer 1. A de-identified
autopsy report, if available
2. Cause of death, and a comment on its possible relationship to the
suspected drug reaction
Two weeks after starting an investigational therapy, a subject is rushed
to the hospital after experiencing a heart attack. The subject is currently
being treated in the Intensive Care Unit (ICU). The ICU doctor has
noticed that the subject was enrolled in the trial and has contacted the
trial Principal Investigator. Heart attack is not described in the
Investigator's Brochure. What actions must be taken by the Principal
Investigator? - answer 1. Report to the Sponsor per the protocol
timelines for serious, unexpected events.
complete updated questions & answers
5 - answer The minimum number of IRB members
Subjects cannot be enrolled until IRB/IEC approval has been obtained -
answer 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 - answer 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? - answer This subject should
undergo all study procedures as outlined in the protocol
A significant risk device is defined as an investigational device that is: -
answer 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 - answer 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 -
answer 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?
- answer 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 - answer 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? - answer A reaction that
is not consistent with the applicable product information
The terms "serious" and "severe" are synonymous according to ICH. -
answer 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 - answer 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? - answer 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? -
answer 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? - answer FALSE
In pre-market approval studies, all noxious and unintended responses
to a medicinal product, even possibly related to any dose, should be
considered which of the following options? - answer Adverse Drug
Reaction
A subject has a suspected serious adverse drug reaction with the
outcome of death. Per the ICH E2A guideline, which are items that
should be submitted to the Sponsor? - answer 1. A de-identified
autopsy report, if available
2. Cause of death, and a comment on its possible relationship to the
suspected drug reaction
Two weeks after starting an investigational therapy, a subject is rushed
to the hospital after experiencing a heart attack. The subject is currently
being treated in the Intensive Care Unit (ICU). The ICU doctor has
noticed that the subject was enrolled in the trial and has contacted the
trial Principal Investigator. Heart attack is not described in the
Investigator's Brochure. What actions must be taken by the Principal
Investigator? - answer 1. Report to the Sponsor per the protocol
timelines for serious, unexpected events.
