1
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CCRP SOCRA Exam - Practice Exam #1
Questions and Answers (100% Correct
Answers) Already Graded A+
The responsibility for ensuring that the investigator understands a
clinical trial lies with which individual/or organization?
A) FDA
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B) IRB
C) Sponsor
D) Coordinator [ ANS: ] C) Sponsor
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What is the minimum number of IRB Members?
A) 3
B) 5
C) 6
D) 10 [ ANS: ] B) 5
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
, 2
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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.
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D) All the above [ ANS: ] D ) All of the above
With respect to IRB/IEC membership, both the FDA and the ICH
require that:
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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 [ ANS: ] C) At least one member's primary
area of interest is in a nonscientific area
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
, 3
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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 [ ANS: ] D) Subjects cannot be enrolled until IRB/IEC
approval has been obtained
A subject has been enrolled on a study and was randomized to
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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?
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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 protocol
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 [ ANS: ] B) This subject should undergo all study
procedures as outlined in the protocol
A purpose of monitoring clinical trials is to verify that:
For Expert help and assignment solutions, +254707240657
CCRP SOCRA Exam - Practice Exam #1
Questions and Answers (100% Correct
Answers) Already Graded A+
The responsibility for ensuring that the investigator understands a
clinical trial lies with which individual/or organization?
A) FDA
© 2025 Assignment Expert
B) IRB
C) Sponsor
D) Coordinator [ ANS: ] C) Sponsor
Guru01 - Stuvia
What is the minimum number of IRB Members?
A) 3
B) 5
C) 6
D) 10 [ ANS: ] B) 5
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
, 2
For Expert help and assignment solutions, +254707240657
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.
© 2025 Assignment Expert
D) All the above [ ANS: ] D ) All of the above
With respect to IRB/IEC membership, both the FDA and the ICH
require that:
Guru01 - Stuvia
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 [ ANS: ] C) At least one member's primary
area of interest is in a nonscientific area
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
, 3
For Expert help and assignment solutions, +254707240657
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 [ ANS: ] D) Subjects cannot be enrolled until IRB/IEC
approval has been obtained
A subject has been enrolled on a study and was randomized to
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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?
Guru01 - Stuvia
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 protocol
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 [ ANS: ] B) This subject should undergo all study
procedures as outlined in the protocol
A purpose of monitoring clinical trials is to verify that:
