ACRP Practice Exam LATEST (2026) COMPLETE
QUESTIONS With 100% Verified Solutions,
Save
Terms in this set (62)
The DSMB has prematurely Subject B returns 12 pills after 8 days on the trial
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?
A subject is issued 120 tablets and is 50%
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?
,Twenty-six subjects were enrolled 92
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?
A subject is participating in a clinical Double blind
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
A clinical trial is being conducted to Phase I
determine the safety and
tolerability of a new anti-emetic IP.
The sponsor expects to enroll 20
subjects. This would be considered
a ______________
, A small biotech company is 2 and 4
investigating the anti-tumoral phase one trials often do PK analysis
potential of scorpion toxin in high Dose escalations are primarily done in Phase I
grade recurrent brain tumors. After trials. Option D is the only choice with both of the
animal trials have been completed, correct statements.
the first trial in humans would MOST
likely involve: ICH E8 3.1.3.1, section-topic: Protocol.
1. healthy volunteers
2. pharmacokinetic analysis
3. placebo control
4. dose escalation
If the patient's weight is 123 lb, what 56
is the weight in kg?
In an effort to increase enrollment notify the IRB/IEC of the change.
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
__________________________
A subject is participating in a lipid- ICH E6 4.8.2, section-topic: Protocol.
lowering clinical trial. Before his 12-
month visit, the CRC receives an a revised consent form
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?
QUESTIONS With 100% Verified Solutions,
Save
Terms in this set (62)
The DSMB has prematurely Subject B returns 12 pills after 8 days on the trial
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?
A subject is issued 120 tablets and is 50%
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?
,Twenty-six subjects were enrolled 92
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?
A subject is participating in a clinical Double blind
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
A clinical trial is being conducted to Phase I
determine the safety and
tolerability of a new anti-emetic IP.
The sponsor expects to enroll 20
subjects. This would be considered
a ______________
, A small biotech company is 2 and 4
investigating the anti-tumoral phase one trials often do PK analysis
potential of scorpion toxin in high Dose escalations are primarily done in Phase I
grade recurrent brain tumors. After trials. Option D is the only choice with both of the
animal trials have been completed, correct statements.
the first trial in humans would MOST
likely involve: ICH E8 3.1.3.1, section-topic: Protocol.
1. healthy volunteers
2. pharmacokinetic analysis
3. placebo control
4. dose escalation
If the patient's weight is 123 lb, what 56
is the weight in kg?
In an effort to increase enrollment notify the IRB/IEC of the change.
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
__________________________
A subject is participating in a lipid- ICH E6 4.8.2, section-topic: Protocol.
lowering clinical trial. Before his 12-
month visit, the CRC receives an a revised consent form
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?
