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 responsibility for ensuring that the investigator understands a clinical trial lies with
which individual/or organization?
A) FDA
B) IRB
C) Sponsor
D) Coordinator - ANSWER C) Sponsor
What is the minimum number of IRB Members?
A) 3
B) 5
C) 6
D) 10 - ANSWER 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
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.
D) All the above - ANSWER 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 -
ANSWER 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 -
ANSWER 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?
3
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 responsibility for ensuring that the investigator understands a clinical trial lies with
which individual/or organization?
A) FDA
B) IRB
C) Sponsor
D) Coordinator - ANSWER C) Sponsor
What is the minimum number of IRB Members?
A) 3
B) 5
C) 6
D) 10 - ANSWER 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
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.
D) All the above - ANSWER 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 -
ANSWER 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 -
ANSWER 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?
3
