DETAILED ANSWERS|LATEST UPDATE!!!!!!2026|GUARANTEED
CORRECT = 100
100
INCORRECT=0
STUDY MATERIALS.......DESIGNED TO HELP YOU SUCCEED
SPOTLIGHT 1
1
, WELL DETAILED ANSWERS|LATEST
UPDATE!!!!!!2026|GUARANTEED PASS|GRADED
The minimum number of IRB members- ANSWER 5
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? - ANSWER Subjects cannot be
enrolled until IRB/IEC approval has been obtained
The responsibility for ensuring that the investigator understands a clinical trial lies with: -
ANSWER The Sponsor
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.
2
,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
3
, . 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.
2. Report to the IRB/IEC per their event reporting requirements for serious, unexpected
events.
4
CORRECT = 100
100
INCORRECT=0
STUDY MATERIALS.......DESIGNED TO HELP YOU SUCCEED
SPOTLIGHT 1
1
, WELL DETAILED ANSWERS|LATEST
UPDATE!!!!!!2026|GUARANTEED PASS|GRADED
The minimum number of IRB members- ANSWER 5
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? - ANSWER Subjects cannot be
enrolled until IRB/IEC approval has been obtained
The responsibility for ensuring that the investigator understands a clinical trial lies with: -
ANSWER The Sponsor
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.
2
,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
3
, . 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.
2. Report to the IRB/IEC per their event reporting requirements for serious, unexpected
events.
4
