ACRP CRC Exam Question Bank Questions With Complete
Solutions
A 1572 is a contract between
a) IRB and FDA
b) Investigator and FDA
c) Sponsor and FDA
d) Sponsor and institution Correct Answers b) Investigator and
FDA
A 510k premarket notification is submitted
a) When the device is a Class I device only
b) Before the initiation of a clinical trial
c) When the device is intended for population of less than 4000
d) When the device to be marketed is substantially equivalent to
the current approved device Correct Answers d) When the
device to be marketed is substantially equivalent to the current
approved device.
A child seven years old is being consented for a juvenile arthritis
clinical trial for a new oral medication. The question that would
be important to ask the child would include all of the following
except
a) Do you understand juvenile arthritis symptoms and causes
b) Do you have difficulty swallowing
c) What oral medications have you take before
d) Do you prefer to have a liquid formulation Correct Answers
a) Do you understand juvenile arthritis symptoms and causes.
A clinical trial in which only the research pharmacist knows the
identity of the test article being given to subjects is a
,a) Single-blind trial
b) Double-blind trial
c) Open label trial
d) Crossover design trial Correct Answers b) Double-blind trial
A clinical trial requires five CT scans in the period of one year.
For the disease condition only one CT scan per year is indicated.
The situation requires
a) The radiation safety committee evaluation and approval prior
to IRB approval
b) Statement about radiation risk in the consent form
c) A consideration of an alternative imaging technique if
possible
d) All of the above Correct Answers d) All of the above.
A control group may consist of all of the following except
a) A group of a distinct age composition
b) A placebo
c) Active Control
d) Different doses of the drug Correct Answers a) A group of a
distinct age composition
A controverted issue is one in which
a) There was a tie vote for the study
b) One or more members abstained from the vote
c) A motion to defer the study was approved
d) Any issue that caused a debate among the members Correct
Answers d) Any issue that caused a debate among the members
A CRC has scheduled a first visit for a subject for an IRB
approved study. When the patient arrives the CRC notices that
,the IRB approval letter is missing a date. The CRC should do all
of the following except
a) Reschedule the visit
b) Contact the IRB and ask for a dated letter
c) Inform the Pl
d) File an unanticipated event report with the IRB Correct
Answers d) File an unanticipated event report with the IRB
A CRC has scheduled a first visit for a subject for an IRB
approved study. When the patient arrives the CRC notices that
the IRB approval letter is missing a date. The CRC should do all
of the following except
e) Reschedule the visit
f) Contact the IRB and ask for a dated letter
g) Inform the PI
h) File an unanticipated event report with the IRB Correct
Answers h) File an unanticipated event report with the IRB
A CRC is preparing a project tracker for following the progress
of enrolled subjects in a clinical trial for study initiation to study
close out. He should follow
a) The protocol
b) The enrollment log
c) The schedule of assessments
d) The screening log Correct Answers c) The schedule of
assessments
A CRC wishes to be ready for potential enrollment into a
clinical trial. The study application is still under review with the
IRB. In this situation the most that he can do is
a) Call potential subjects and discuss enrollment
, b) Review the proposed informed consent form with potential
subjects
c) Review the medical records of potential subjects for
eligibility
d) Review the PI's previous list of treated subjects to assess if
enrollment targets will be met. Correct Answers d) Review the
PI's previous list of treated subjects to assess if enrollment
targets will be met.
A data and safety monitoring board does all of the following
except
a) Supports SAE review by the IRB
b) Assesses progress of a clinical trial and critical efficacy
endpoints
c) Monitors all aspects of data safety for a clinical trial
d) Recommends to the sponsor whether a trial should be
continued, modified, or stopped Correct Answers a) Supports
SAE review by the IRB
A development plan purpose is to:
a) Find a dose range that is simultaneously safe and effective.
b) Prove that the risk benefit relationship is acceptable
c) Identify the subjects who would most benefit and indications
for the use.
d) All of the above Correct Answers d) All of the above
A double blind trial is one in which the following are unaware of
the treatment received:
a) Sponsor
b) Investigator
c) Subject
Solutions
A 1572 is a contract between
a) IRB and FDA
b) Investigator and FDA
c) Sponsor and FDA
d) Sponsor and institution Correct Answers b) Investigator and
FDA
A 510k premarket notification is submitted
a) When the device is a Class I device only
b) Before the initiation of a clinical trial
c) When the device is intended for population of less than 4000
d) When the device to be marketed is substantially equivalent to
the current approved device Correct Answers d) When the
device to be marketed is substantially equivalent to the current
approved device.
A child seven years old is being consented for a juvenile arthritis
clinical trial for a new oral medication. The question that would
be important to ask the child would include all of the following
except
a) Do you understand juvenile arthritis symptoms and causes
b) Do you have difficulty swallowing
c) What oral medications have you take before
d) Do you prefer to have a liquid formulation Correct Answers
a) Do you understand juvenile arthritis symptoms and causes.
A clinical trial in which only the research pharmacist knows the
identity of the test article being given to subjects is a
,a) Single-blind trial
b) Double-blind trial
c) Open label trial
d) Crossover design trial Correct Answers b) Double-blind trial
A clinical trial requires five CT scans in the period of one year.
For the disease condition only one CT scan per year is indicated.
The situation requires
a) The radiation safety committee evaluation and approval prior
to IRB approval
b) Statement about radiation risk in the consent form
c) A consideration of an alternative imaging technique if
possible
d) All of the above Correct Answers d) All of the above.
A control group may consist of all of the following except
a) A group of a distinct age composition
b) A placebo
c) Active Control
d) Different doses of the drug Correct Answers a) A group of a
distinct age composition
A controverted issue is one in which
a) There was a tie vote for the study
b) One or more members abstained from the vote
c) A motion to defer the study was approved
d) Any issue that caused a debate among the members Correct
Answers d) Any issue that caused a debate among the members
A CRC has scheduled a first visit for a subject for an IRB
approved study. When the patient arrives the CRC notices that
,the IRB approval letter is missing a date. The CRC should do all
of the following except
a) Reschedule the visit
b) Contact the IRB and ask for a dated letter
c) Inform the Pl
d) File an unanticipated event report with the IRB Correct
Answers d) File an unanticipated event report with the IRB
A CRC has scheduled a first visit for a subject for an IRB
approved study. When the patient arrives the CRC notices that
the IRB approval letter is missing a date. The CRC should do all
of the following except
e) Reschedule the visit
f) Contact the IRB and ask for a dated letter
g) Inform the PI
h) File an unanticipated event report with the IRB Correct
Answers h) File an unanticipated event report with the IRB
A CRC is preparing a project tracker for following the progress
of enrolled subjects in a clinical trial for study initiation to study
close out. He should follow
a) The protocol
b) The enrollment log
c) The schedule of assessments
d) The screening log Correct Answers c) The schedule of
assessments
A CRC wishes to be ready for potential enrollment into a
clinical trial. The study application is still under review with the
IRB. In this situation the most that he can do is
a) Call potential subjects and discuss enrollment
, b) Review the proposed informed consent form with potential
subjects
c) Review the medical records of potential subjects for
eligibility
d) Review the PI's previous list of treated subjects to assess if
enrollment targets will be met. Correct Answers d) Review the
PI's previous list of treated subjects to assess if enrollment
targets will be met.
A data and safety monitoring board does all of the following
except
a) Supports SAE review by the IRB
b) Assesses progress of a clinical trial and critical efficacy
endpoints
c) Monitors all aspects of data safety for a clinical trial
d) Recommends to the sponsor whether a trial should be
continued, modified, or stopped Correct Answers a) Supports
SAE review by the IRB
A development plan purpose is to:
a) Find a dose range that is simultaneously safe and effective.
b) Prove that the risk benefit relationship is acceptable
c) Identify the subjects who would most benefit and indications
for the use.
d) All of the above Correct Answers d) All of the above
A double blind trial is one in which the following are unaware of
the treatment received:
a) Sponsor
b) Investigator
c) Subject
