CCRP SOCRA Exam - Practice Exam #1 Practice Test
#1 (Ethics, 21 CFR Parts 50, 56, 312, 812; 45 CFR
Part 46) Past questions directly from SOCRA. /
Actual Exam Questions with Detailed Answers / A+
Grade Assured / 2025
Terms in this set (50)
The responsibility for C) Sponsor
ensuring that the
investigator understands a
clinical trial lies with which
individual/or organization?
A) FDA
B) IRB
C) Sponsor
D) Coordinator
What is the minimum number B) 5
of IRB Members?
A) 3
B) 5
C) 6
D) 10
,A significant risk device is D ) All of the above
defined as an investigational
device that is:
A) Intended as an
implantand presents a
potential for serious risk to
the health, safety, or welfare
of a subject
B) Purported
orrepresented 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
substantialimportance 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
, With respect to IRB/IEC C) At least one member's primary area of interest is in a
membership, both the FDA nonscientific area
and the ICH require that:
A) A majority of
themembers' primary area of
interest is in a scientific area
B) At least one
memberholds a Ph.D. degree
or equivalent
C) At least one
member'sprimary area of
interest is in a nonscientific
area D) A majority of the
members are from or have
ties to the institution of
record
#1 (Ethics, 21 CFR Parts 50, 56, 312, 812; 45 CFR
Part 46) Past questions directly from SOCRA. /
Actual Exam Questions with Detailed Answers / A+
Grade Assured / 2025
Terms in this set (50)
The responsibility for C) Sponsor
ensuring that the
investigator understands a
clinical trial lies with which
individual/or organization?
A) FDA
B) IRB
C) Sponsor
D) Coordinator
What is the minimum number B) 5
of IRB Members?
A) 3
B) 5
C) 6
D) 10
,A significant risk device is D ) All of the above
defined as an investigational
device that is:
A) Intended as an
implantand presents a
potential for serious risk to
the health, safety, or welfare
of a subject
B) Purported
orrepresented 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
substantialimportance 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
, With respect to IRB/IEC C) At least one member's primary area of interest is in a
membership, both the FDA nonscientific area
and the ICH require that:
A) A majority of
themembers' primary area of
interest is in a scientific area
B) At least one
memberholds a Ph.D. degree
or equivalent
C) At least one
member'sprimary area of
interest is in a nonscientific
area D) A majority of the
members are from or have
ties to the institution of
record
