CCRP SOCRA EXAM - PRACTICE
EXAM #1 QUESTIONS WITH
VERIFIED ANSWERS
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
What is the minimum number of IRB Members?
A) 3
B) 5
C) 6
D) 10
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
,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
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
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
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?
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
B) This subject should undergo all study procedures as outlined in the
protocol
EXAM #1 QUESTIONS WITH
VERIFIED ANSWERS
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
What is the minimum number of IRB Members?
A) 3
B) 5
C) 6
D) 10
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
,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
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
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
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?
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
B) This subject should undergo all study procedures as outlined in the
protocol
