CCRC Practice Exam
The DSMB has prematurely terminated a trial evaluating an investigational pain
medication that is taken one caplet orally b.i.d. for chronic hip pain. Subjects are
allowed to take one extra caplet per day. Subjects receive a sufficient quantity of IP for
14 days plus two additional doses. Which of the following represents a drug
accountability issue?
1) Subject A returns 24 pills after 10 days on trial.
2) Subject B returns 12 pills after 8 days on the trial.
3) Subject C returns 29 pills after 5 days on the trial.
4)Subject D returns 42 pills after 1 day on the trial. - answer Subject B returns 12 pills
after 8 days on the trial.
A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He
returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent
compliant is he? - answer50%
Twenty-six subjects were enrolled in a pneumonia trial. The site received 100 bottles of
IP. Each subject received two bottles. Four subjects did not return their trial bottles. How
many bottles are available for the CRC to return to the sponsor at the end of the trial? -
answer92
A subject is participating in a clinical trial where only the pharmacist and the sponsor
know the identity of the IP. The pharmacist has no direct contact with the trial subject
and the clinical team. Which of the following BEST describes this trial type? -
answerdouble-blind
A clinical trial is being conducted to determine the safety and tolerability of a new anti-
emetic IP. The sponsor expects to enroll 20 subjects. This would be considered a
______________. - answerPhase I trial
A small biotech company is investigating the anti-tumoral potential of scorpion toxin in
high grade recurrent brain tumors. After animal trials have been completed, the first trial
in humans would MOST likely involve:
1. healthy volunteers
2. pharmacokinetic analysis
3. placebo control
4. dose escalation - answer2 and 4 only
, If the patient's weight is 123 lb, what is the weight in kg? - answer56
In an effort to increase enrollment in an ongoing trial, the sponsor has broadened
inclusion/exclusion criteria to increase the allowable creatinine level. The next step the
CRC should take is to __________________________. - answernotify the IRB/IEC of
the change.
A subject is participating in a lipid-lowering clinical trial. Before his 12-month visit, the
CRC receives an amendment from the sponsor that includes an outcomes
measurement instrument at the 12-month visit. The CRC should FIRST provide the
subject with which of the following? - answera revised consent form
The protocol and protocol summary have been submitted to a central IRB/IEC for
review/approval by the CRO prior to the investigators' meeting. Following the meeting,
the entry criteria are altered to facilitate the recruitment and retention of eligible
subjects. Prior to trial start-up, the regulatory binder must include:
1. an IRB/IEC letter of approval for the amended protocol
2. an IRB/IEC site evaluation form
3. the amended protocol
4. the Investigator's Brochure - answer1, 3, and 4 only
Which of the following is a liver function test? - answerLDH
Hct - answerblood test measuring the percentage of the volume of whole blood that is
made up of red blood cells.
LDH - answertest used to check for damage to the tissue of the heart, liver, kidney,
muscles, brain, blood cells, and lungs.
TSH - answertest used to assess the function of the thyroid gland.
BUN - answerkidney function test
At the month-3 visit of a Phase III double-blind trial, the subject informs the CRC that he
was seen in the emergency department for an anaphylactic reaction. The subject states,
"The doctor told me I was very lucky. I might have died." Having received this
information, the MOST appropriate sequence of action is to inform the
___________________________. - answerPI, sponsor, and IRB/IEC.
Which of the following scenarios are considered SAEs?
1. infection following surgery prolonging hospital stay
2. pregnancy resulting in normal delivery of twins
3. boating accident with overnight hospitalization
4. use of illicit drug during the trial - answer1 and 3 only
The DSMB has prematurely terminated a trial evaluating an investigational pain
medication that is taken one caplet orally b.i.d. for chronic hip pain. Subjects are
allowed to take one extra caplet per day. Subjects receive a sufficient quantity of IP for
14 days plus two additional doses. Which of the following represents a drug
accountability issue?
1) Subject A returns 24 pills after 10 days on trial.
2) Subject B returns 12 pills after 8 days on the trial.
3) Subject C returns 29 pills after 5 days on the trial.
4)Subject D returns 42 pills after 1 day on the trial. - answer Subject B returns 12 pills
after 8 days on the trial.
A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He
returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent
compliant is he? - answer50%
Twenty-six subjects were enrolled in a pneumonia trial. The site received 100 bottles of
IP. Each subject received two bottles. Four subjects did not return their trial bottles. How
many bottles are available for the CRC to return to the sponsor at the end of the trial? -
answer92
A subject is participating in a clinical trial where only the pharmacist and the sponsor
know the identity of the IP. The pharmacist has no direct contact with the trial subject
and the clinical team. Which of the following BEST describes this trial type? -
answerdouble-blind
A clinical trial is being conducted to determine the safety and tolerability of a new anti-
emetic IP. The sponsor expects to enroll 20 subjects. This would be considered a
______________. - answerPhase I trial
A small biotech company is investigating the anti-tumoral potential of scorpion toxin in
high grade recurrent brain tumors. After animal trials have been completed, the first trial
in humans would MOST likely involve:
1. healthy volunteers
2. pharmacokinetic analysis
3. placebo control
4. dose escalation - answer2 and 4 only
, If the patient's weight is 123 lb, what is the weight in kg? - answer56
In an effort to increase enrollment in an ongoing trial, the sponsor has broadened
inclusion/exclusion criteria to increase the allowable creatinine level. The next step the
CRC should take is to __________________________. - answernotify the IRB/IEC of
the change.
A subject is participating in a lipid-lowering clinical trial. Before his 12-month visit, the
CRC receives an amendment from the sponsor that includes an outcomes
measurement instrument at the 12-month visit. The CRC should FIRST provide the
subject with which of the following? - answera revised consent form
The protocol and protocol summary have been submitted to a central IRB/IEC for
review/approval by the CRO prior to the investigators' meeting. Following the meeting,
the entry criteria are altered to facilitate the recruitment and retention of eligible
subjects. Prior to trial start-up, the regulatory binder must include:
1. an IRB/IEC letter of approval for the amended protocol
2. an IRB/IEC site evaluation form
3. the amended protocol
4. the Investigator's Brochure - answer1, 3, and 4 only
Which of the following is a liver function test? - answerLDH
Hct - answerblood test measuring the percentage of the volume of whole blood that is
made up of red blood cells.
LDH - answertest used to check for damage to the tissue of the heart, liver, kidney,
muscles, brain, blood cells, and lungs.
TSH - answertest used to assess the function of the thyroid gland.
BUN - answerkidney function test
At the month-3 visit of a Phase III double-blind trial, the subject informs the CRC that he
was seen in the emergency department for an anaphylactic reaction. The subject states,
"The doctor told me I was very lucky. I might have died." Having received this
information, the MOST appropriate sequence of action is to inform the
___________________________. - answerPI, sponsor, and IRB/IEC.
Which of the following scenarios are considered SAEs?
1. infection following surgery prolonging hospital stay
2. pregnancy resulting in normal delivery of twins
3. boating accident with overnight hospitalization
4. use of illicit drug during the trial - answer1 and 3 only
