ACRP CCRC EXAM REVIEW; 138 QUESTIONS
WITH 100% CORRECT ANSWERS; VERIFIED;
LATEST UPDATE 2025-2026
A CBC is drawn on a study subject at Visit 3. The specimen cannot be
transported to the central laboratory until the following day. What
should the CRC do to protect the integrity of the specimen?
A. Store the CBC in the refrigerator, then transport the plasma on wet
ice the next day
B. Store the CBC at room temperature then transport in an ambient bag
the next day
C. Freeze the CBC at -70 then transport frozen the next day
D. Freeze at -20 then transport on dry ice the next day - correct
answer- B
Not C & D b/c cells heomlyse when frozen; A is wrong b/c it excludes the
RBC and only includes plasma
A change in weight of greater than or equal to 10% between Visits 1 and
3 is an exclusion criterion. The subject weight 130lbs at Visit 1. The
subject would be excluded at what minimum weight prior to or at Visit
3?
,A. 135
B. 143
C. 145
D. 150 - correct answer- B
A CRA has sent the site a pre-study informational packet in preparation
for an upcoming site visit. For the staff to know as much about the
history of the drug as possible, they should read the
A. Study protocol
B. Informed consent
C. Investigational plan
D. Investigator's brochure - correct answer- D
A CRA is responsible for which of the following during a monitoring visit?
1. Verifying subject protection
2. confirming source data
3. assuring protocol compliance
4. reviewing medical charts for potential subjects
A. 1, 2 & 3
,B. 1, 2 & 4
C. 1, 3 & 4
D. 2, 3 & 4 - correct answer- A
Reason: The main function of the CRA is to assure that the study is being
performed according to the protocol and all applicable
regulations/guidelines. CRAs can only review charts as part of source
data verification after a trial subject has given his or her permission by
signing an informed consent document, so Option 4 is wrong.
A CRC is preparing the final report to the sponsor for an osteoporosis
study. He/she learns that a sub-investigator did not perform the exit
physical examinations for six subjects as required by the protocol. Which
of the following should the CRC do FIRST?
A. Schedule the subject for an exit physical examination.
B. Inform the PI of the protocol deviation.
C. Complete the report and a note to file about the missing data
deviation.
D. Ask the sub-investigator to mark the physical exam CRF as "not done."
- correct answer- B
Reason: The PI should be informed of these protocol deviations as the
initial step. Subsequently, the CRC should ensure the sub-investigator
completes the CRF as "not don't" and document the deviation with a
note to file accordingly. As study subject participation has completed as
, this point, any opportunity to schedule those subjects for an exit physical
examination has passed. According to ICH-GCP 4.13, the PI is responsible
for any final report sent to the sponsor.
A CRC is reviewing a protocol for a Phase I study. The objective for
conducting the study could be to determine the
A. Safety and efficacy of chemotherapy "x" versus placebo in alleviating
pain in osteoarthritis patients
B. Dose of test articles/investigational product in reducing soft tissue
inflammation following third molar extraction
C. Dose at which caffeine enhances acetylsalicylic acid absorption in
normal, healthy volunteers.
D. Blood levels of acetaminophen in post-partum patients when taken
on an empty stomach versus two hours after meal consumption. -
correct answer- C
Reason: Phase I studies are most commonly conducted in normal,
healthy volunteers, a unique characteristic of this phase of development.
Theoretically, none of the other objectives stated in A, B or D contain
characteristics as unique to Phase I and may, in fat, be stated as
objectives of studies conducted in later phases of development.
A CRO has been enlisted to oversee a study, who is primarily responsible
for integrity of trial data? - correct answer- sponsor
WITH 100% CORRECT ANSWERS; VERIFIED;
LATEST UPDATE 2025-2026
A CBC is drawn on a study subject at Visit 3. The specimen cannot be
transported to the central laboratory until the following day. What
should the CRC do to protect the integrity of the specimen?
A. Store the CBC in the refrigerator, then transport the plasma on wet
ice the next day
B. Store the CBC at room temperature then transport in an ambient bag
the next day
C. Freeze the CBC at -70 then transport frozen the next day
D. Freeze at -20 then transport on dry ice the next day - correct
answer- B
Not C & D b/c cells heomlyse when frozen; A is wrong b/c it excludes the
RBC and only includes plasma
A change in weight of greater than or equal to 10% between Visits 1 and
3 is an exclusion criterion. The subject weight 130lbs at Visit 1. The
subject would be excluded at what minimum weight prior to or at Visit
3?
,A. 135
B. 143
C. 145
D. 150 - correct answer- B
A CRA has sent the site a pre-study informational packet in preparation
for an upcoming site visit. For the staff to know as much about the
history of the drug as possible, they should read the
A. Study protocol
B. Informed consent
C. Investigational plan
D. Investigator's brochure - correct answer- D
A CRA is responsible for which of the following during a monitoring visit?
1. Verifying subject protection
2. confirming source data
3. assuring protocol compliance
4. reviewing medical charts for potential subjects
A. 1, 2 & 3
,B. 1, 2 & 4
C. 1, 3 & 4
D. 2, 3 & 4 - correct answer- A
Reason: The main function of the CRA is to assure that the study is being
performed according to the protocol and all applicable
regulations/guidelines. CRAs can only review charts as part of source
data verification after a trial subject has given his or her permission by
signing an informed consent document, so Option 4 is wrong.
A CRC is preparing the final report to the sponsor for an osteoporosis
study. He/she learns that a sub-investigator did not perform the exit
physical examinations for six subjects as required by the protocol. Which
of the following should the CRC do FIRST?
A. Schedule the subject for an exit physical examination.
B. Inform the PI of the protocol deviation.
C. Complete the report and a note to file about the missing data
deviation.
D. Ask the sub-investigator to mark the physical exam CRF as "not done."
- correct answer- B
Reason: The PI should be informed of these protocol deviations as the
initial step. Subsequently, the CRC should ensure the sub-investigator
completes the CRF as "not don't" and document the deviation with a
note to file accordingly. As study subject participation has completed as
, this point, any opportunity to schedule those subjects for an exit physical
examination has passed. According to ICH-GCP 4.13, the PI is responsible
for any final report sent to the sponsor.
A CRC is reviewing a protocol for a Phase I study. The objective for
conducting the study could be to determine the
A. Safety and efficacy of chemotherapy "x" versus placebo in alleviating
pain in osteoarthritis patients
B. Dose of test articles/investigational product in reducing soft tissue
inflammation following third molar extraction
C. Dose at which caffeine enhances acetylsalicylic acid absorption in
normal, healthy volunteers.
D. Blood levels of acetaminophen in post-partum patients when taken
on an empty stomach versus two hours after meal consumption. -
correct answer- C
Reason: Phase I studies are most commonly conducted in normal,
healthy volunteers, a unique characteristic of this phase of development.
Theoretically, none of the other objectives stated in A, B or D contain
characteristics as unique to Phase I and may, in fat, be stated as
objectives of studies conducted in later phases of development.
A CRO has been enlisted to oversee a study, who is primarily responsible
for integrity of trial data? - correct answer- sponsor
