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CCRP Practice Exam Questions and
Answers 100% Pass
21 CFR Part 56 - ANS Institutional Review Boards
Emergency use - ANS Use of the test on a human subject in a life-threatening situation in
which no standard acceptable treatment is available, and there is not sufficient time to obtain
IRB approval
IRB purpose - ANS To assure the protection of the rights and welfare of human subjects
Investigator - ANS Individual who conducts a clinical investigation. Responsible leader of the
investigator team.
Sponsor - ANS Person or group that initiates a clinical investigation, but does not actually
conduct the investigation.
Sponsor-investigator - ANS an individual who initiatesa nd actually conducts the study. Does
not include a corporation or agency.
Minimal risk - ANS The probability and magnitude of harm or discomfort in the research are
not greater than those ordinarily encountered in daily life or performance of routine physical or
psychological examiniation or tests.
Exemptions from IRB requirement - ANS a) investigation which commenced before July 27,
1981
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, ©FYNDLAY 2025 ALL RIGHTS RESERVED
c) emergency use
Emergency use of a test article must be reported to the IRB within ____ working days? -
ANS 5 days
The FDA may waive requirements, including IRB review for specific research activities (T or F) -
ANS True
What is an active protocol and how many months is considered "active" - ANS A protocol in
wich the IRB has conducted it's initial review within the pase 12 months
When must an IRB register? When does it have to be renewed? Who has to accept the IRB
registration? - ANS Each IRB must submit an initial registration. Initial registration must occur
before the IRB beings to review a clinical investigation. Each IRB must review its registration
every 3 months. The HHS reviews and accepts IRB registrations.
How does an IRB revise its registration information? How long do they have to report the
changes? - ANS IRB must submit any changes of IRB contact or chair person within 90 days of
the change.
An IRBs decision to review a new type of FDA regulated product (i.e. they reviewed drug
studies, but now they review food) or discontinue reviewing clinical investigations must be
reported within 30 days of the change.
An IRBs decision to disband is a change that must be reported within 30 days.
Any other changes may be done when the IRB renews
Can a IRB group be all male or all female? - ANS No IRB consists of entirely men or entirely
women
How many members are needed on an IRB team? - ANS At least 5 members.
Can an IRB group consist entirely of one profession? - ANS 2) No IRB may consist of one
profession
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CCRP Practice Exam Questions and
Answers 100% Pass
21 CFR Part 56 - ANS Institutional Review Boards
Emergency use - ANS Use of the test on a human subject in a life-threatening situation in
which no standard acceptable treatment is available, and there is not sufficient time to obtain
IRB approval
IRB purpose - ANS To assure the protection of the rights and welfare of human subjects
Investigator - ANS Individual who conducts a clinical investigation. Responsible leader of the
investigator team.
Sponsor - ANS Person or group that initiates a clinical investigation, but does not actually
conduct the investigation.
Sponsor-investigator - ANS an individual who initiatesa nd actually conducts the study. Does
not include a corporation or agency.
Minimal risk - ANS The probability and magnitude of harm or discomfort in the research are
not greater than those ordinarily encountered in daily life or performance of routine physical or
psychological examiniation or tests.
Exemptions from IRB requirement - ANS a) investigation which commenced before July 27,
1981
©FYNDLAY 1
, ©FYNDLAY 2025 ALL RIGHTS RESERVED
c) emergency use
Emergency use of a test article must be reported to the IRB within ____ working days? -
ANS 5 days
The FDA may waive requirements, including IRB review for specific research activities (T or F) -
ANS True
What is an active protocol and how many months is considered "active" - ANS A protocol in
wich the IRB has conducted it's initial review within the pase 12 months
When must an IRB register? When does it have to be renewed? Who has to accept the IRB
registration? - ANS Each IRB must submit an initial registration. Initial registration must occur
before the IRB beings to review a clinical investigation. Each IRB must review its registration
every 3 months. The HHS reviews and accepts IRB registrations.
How does an IRB revise its registration information? How long do they have to report the
changes? - ANS IRB must submit any changes of IRB contact or chair person within 90 days of
the change.
An IRBs decision to review a new type of FDA regulated product (i.e. they reviewed drug
studies, but now they review food) or discontinue reviewing clinical investigations must be
reported within 30 days of the change.
An IRBs decision to disband is a change that must be reported within 30 days.
Any other changes may be done when the IRB renews
Can a IRB group be all male or all female? - ANS No IRB consists of entirely men or entirely
women
How many members are needed on an IRB team? - ANS At least 5 members.
Can an IRB group consist entirely of one profession? - ANS 2) No IRB may consist of one
profession
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