1. The responsibility for ensuring that the investi- C) Sponsor
gator understands a clinical trial lies with which
individual/or organization?
A) FDA
B) IRB
C) Sponsor
D) Coordinator
2. What is the minimum number of IRB Members? B) 5
A) 3
B) 5
C) 6
D) 10
3. A significant risk device is defined as an investiga- D ) All of the above
tional device that is:
A) Intended as an implant and presents a poten-
tial 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 diagnos-
ing, curing, mitigating, or treating disease, or oth-
erwise 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
4. With respect to IRB/IEC membership, both the C) At least one member's primary
FDA and the ICH require that: area of interest is in a nonscientific
A) A majority of the members' primary area of area
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
5. In a non-emergency situation, under which of the D) Subjects cannot be enrolled
following conditions, if any, may subjects been until IRB/IEC approval has been
rolled into a study prior to IRB/IEC approval? obtained
A) The investigator provides his/her written ap-
proval
B) The study drug has an FDA approved market-
ing application
C) The FDA provides written approval of the IND
D) Subjects cannot be enrolled until IRB/IEC ap-
proval has been obtained
6. A subject has been enrolled on a study and was B) This subject should undergo all
randomized to the non-treatment arm. The pro- study procedures as outlined in
tocol outlines study procedures for all subjects the protocol
to be performed within one week of enrollment.
gator understands a clinical trial lies with which
individual/or organization?
A) FDA
B) IRB
C) Sponsor
D) Coordinator
2. What is the minimum number of IRB Members? B) 5
A) 3
B) 5
C) 6
D) 10
3. A significant risk device is defined as an investiga- D ) All of the above
tional device that is:
A) Intended as an implant and presents a poten-
tial 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 diagnos-
ing, curing, mitigating, or treating disease, or oth-
erwise 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
4. With respect to IRB/IEC membership, both the C) At least one member's primary
FDA and the ICH require that: area of interest is in a nonscientific
A) A majority of the members' primary area of area
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
5. In a non-emergency situation, under which of the D) Subjects cannot be enrolled
following conditions, if any, may subjects been until IRB/IEC approval has been
rolled into a study prior to IRB/IEC approval? obtained
A) The investigator provides his/her written ap-
proval
B) The study drug has an FDA approved market-
ing application
C) The FDA provides written approval of the IND
D) Subjects cannot be enrolled until IRB/IEC ap-
proval has been obtained
6. A subject has been enrolled on a study and was B) This subject should undergo all
randomized to the non-treatment arm. The pro- study procedures as outlined in
tocol outlines study procedures for all subjects the protocol
to be performed within one week of enrollment.
