CCRP SOCRA Exam - Practice Exam 1 Questions with
Answers
1. The responsibility for ensuring that the investigator understands a
clinical trial lies with which individual/or organization?
A) FDA
B) IRB
C) Sponsor
D) Coordinator: C) Sponsor
2. What is the minimum number of IRB Members?
A) 3
B) 5
C) 6
D) 10: B) 5
3. 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.
D) All the above: D ) All of the above
4. With respect to IRB/IEC membership, both the FDA and the ICH require
that:
A) A majority of the members' primary area of interest is in a scientific area
B) At least one member holds a Ph.D. degree or equivalent
C) At least one member's primary area of interest is in a nonscientific area
D) A majority of the members are from or have ties to the institution of
record: C) At least one member's primary area of interest is in a
nonscientific area
5. In a non-emergency situation, under which of the following
, conditions, if any, may subjects been rolled into a study prior to IRB/IEC
approval?
A) The investigator provides his/her written approval
B) The study drug has an FDA approved marketing application
C) The FDA provides written approval of the IND
D) Subjects cannot be enrolled until IRB/IEC approval has been obtained:
D) Subjects cannot be enrolled until IRB/IEC approval has been
obtained
6. A subject has been enrolled on a study and was randomized to the non-
treat- ment 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) This subject does not need to undergo any of the study procedures
since the subject is enrolled on the non-treatment arm
B) This subject should undergo all study procedures as outlined in the
proto- col
C) This subject only needs to undergo the study procedures that
pertain specifically to the subject
D) This subject can undergo the study procedures whenever it is convenient-
: B) This subject should undergo all study procedures as outlined in the
protocol
7. A purpose of monitoring clinical trials is to verify that:
A) The rights, safety, and well-being of human subjects are protected
B) Investigators receive adequate payment for their participation in the
clinical trial
C) The investigator has received annual reports from the sponsor
D) The regulatory agency has received all case history information of
subjects enrolled on the clinical trial: A) The rights, safety, and well-being
Answers
1. The responsibility for ensuring that the investigator understands a
clinical trial lies with which individual/or organization?
A) FDA
B) IRB
C) Sponsor
D) Coordinator: C) Sponsor
2. What is the minimum number of IRB Members?
A) 3
B) 5
C) 6
D) 10: B) 5
3. 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.
D) All the above: D ) All of the above
4. With respect to IRB/IEC membership, both the FDA and the ICH require
that:
A) A majority of the members' primary area of interest is in a scientific area
B) At least one member holds a Ph.D. degree or equivalent
C) At least one member's primary area of interest is in a nonscientific area
D) A majority of the members are from or have ties to the institution of
record: C) At least one member's primary area of interest is in a
nonscientific area
5. In a non-emergency situation, under which of the following
, conditions, if any, may subjects been rolled into a study prior to IRB/IEC
approval?
A) The investigator provides his/her written approval
B) The study drug has an FDA approved marketing application
C) The FDA provides written approval of the IND
D) Subjects cannot be enrolled until IRB/IEC approval has been obtained:
D) Subjects cannot be enrolled until IRB/IEC approval has been
obtained
6. A subject has been enrolled on a study and was randomized to the non-
treat- ment 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) This subject does not need to undergo any of the study procedures
since the subject is enrolled on the non-treatment arm
B) This subject should undergo all study procedures as outlined in the
proto- col
C) This subject only needs to undergo the study procedures that
pertain specifically to the subject
D) This subject can undergo the study procedures whenever it is convenient-
: B) This subject should undergo all study procedures as outlined in the
protocol
7. A purpose of monitoring clinical trials is to verify that:
A) The rights, safety, and well-being of human subjects are protected
B) Investigators receive adequate payment for their participation in the
clinical trial
C) The investigator has received annual reports from the sponsor
D) The regulatory agency has received all case history information of
subjects enrolled on the clinical trial: A) The rights, safety, and well-being
