ACRP CCRC LATEST 2026 EXAMS SCRIPTED QUESTIONS
AND ANSWERS GRADED A+
✔✔The CRC is preparing the budget for the protocol. The cost of the study is $12,000.
The indirect cost rate for the institution is 25%. The total cost of the protocol is
A. $12,000
B. $13,500
C. $15,000
D. $15,500 - ✔✔C
Reason: To accurately project and cover costs associated w/ the conduct of a study, the
site would calculate total cost by multiplying the study cost times the institution's indirect
cost ($12,000 x .25 = $3,000) and summing the two for a total study cost to be
submitted to the sponsor of $15,000. Failure to factor the indirect cost for the institution
into the budget may result in the study being conducted at a loss.
✔✔At the final visit, the CRC discovers that a subject has not been taking the test
article/investigational product as directed. However, according to the pill counts
conducted throughout the study, the subject appeared to be compliant. Which of the
following should the CRC do in this situation?
A. Recalculate compliance for each visit to determine a more accurate compliance
percentage based on the subject's verbal account.
B. Document the available information surrounding the noncompliance in the source
document.
C. Report the subject's noncompliance as an adverse event to the IRB/IEC.
D. Classify the subject as dropped from the date at which the noncompliance began. -
✔✔B
Reason: In this scenario, the subject reveals that he/she was not compliant with taking
the test article/investigational product as directed, despite the pill count indicating
otherwise. Recalculation based on the subject's verbal account rather than amounts
dispensed and returned would be inappropriate. Option C is incorrect because this is
not a significant hazard, so it should not be reported to the IRB/IEC by the PI.
Technically, the subject did not drop out of the study; therefore, classifying him/her as
such would not be accurate. A CRC becoming knowledgeable about such
noncompliance should document this information in accordance w/ GCP, as the
noncompliance may have a serious and potentially significant impact on the clinical
research results.
✔✔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." - ✔✔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.
✔✔If the reference laboratory normal values change in the course of the study, which of
the following actions should the CRC take?
A. No action is indicated
B. The new reference values are inserted in the regulatory/site file
C. The PI documents the change in all subject's source documents.
D. All subject's data are reviewed by the PI for significance for both pre- and post-
change periods. - ✔✔B
Reason: A is incorrect because the new values should not be ignored. B is correct
because normal ranges constitute "essential documents," according to ICH-GCP 8.2.11,
C and D are not necessary because new laboratory reports will contain the new values.
✔✔Which of the following tasks should a CRC complete prior to the enrollment of
subjects?
1. Conduct initial protocol training with site staff
2. Coordinate the process for completion of study related procedures and tests.
3. Inform primary care physician of subject's interest in the study.
4. Discontinue all excluded medications for potential subjects.
A. 1 and 2 only
B. 1 and 4 only
C. 2 and 3 only
D. 3 and 4 only - ✔✔A
Reason: Prior to screening subjects, site staff should be appropriately trained on the
protocol and study-related procedures. In addition, the role of the CRC is to coordinate
study-related testing with other departments. Informing the subject's primary care
physician of the subject's interest in the study is suggested by ICH-GCP, but only with
the consent of the subject, which is not presented in Option C. Finally, Option D is
incorrect because it is inappropriate to discontinue medications without informed
consent first being obtained from the subject.
AND ANSWERS GRADED A+
✔✔The CRC is preparing the budget for the protocol. The cost of the study is $12,000.
The indirect cost rate for the institution is 25%. The total cost of the protocol is
A. $12,000
B. $13,500
C. $15,000
D. $15,500 - ✔✔C
Reason: To accurately project and cover costs associated w/ the conduct of a study, the
site would calculate total cost by multiplying the study cost times the institution's indirect
cost ($12,000 x .25 = $3,000) and summing the two for a total study cost to be
submitted to the sponsor of $15,000. Failure to factor the indirect cost for the institution
into the budget may result in the study being conducted at a loss.
✔✔At the final visit, the CRC discovers that a subject has not been taking the test
article/investigational product as directed. However, according to the pill counts
conducted throughout the study, the subject appeared to be compliant. Which of the
following should the CRC do in this situation?
A. Recalculate compliance for each visit to determine a more accurate compliance
percentage based on the subject's verbal account.
B. Document the available information surrounding the noncompliance in the source
document.
C. Report the subject's noncompliance as an adverse event to the IRB/IEC.
D. Classify the subject as dropped from the date at which the noncompliance began. -
✔✔B
Reason: In this scenario, the subject reveals that he/she was not compliant with taking
the test article/investigational product as directed, despite the pill count indicating
otherwise. Recalculation based on the subject's verbal account rather than amounts
dispensed and returned would be inappropriate. Option C is incorrect because this is
not a significant hazard, so it should not be reported to the IRB/IEC by the PI.
Technically, the subject did not drop out of the study; therefore, classifying him/her as
such would not be accurate. A CRC becoming knowledgeable about such
noncompliance should document this information in accordance w/ GCP, as the
noncompliance may have a serious and potentially significant impact on the clinical
research results.
✔✔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." - ✔✔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.
✔✔If the reference laboratory normal values change in the course of the study, which of
the following actions should the CRC take?
A. No action is indicated
B. The new reference values are inserted in the regulatory/site file
C. The PI documents the change in all subject's source documents.
D. All subject's data are reviewed by the PI for significance for both pre- and post-
change periods. - ✔✔B
Reason: A is incorrect because the new values should not be ignored. B is correct
because normal ranges constitute "essential documents," according to ICH-GCP 8.2.11,
C and D are not necessary because new laboratory reports will contain the new values.
✔✔Which of the following tasks should a CRC complete prior to the enrollment of
subjects?
1. Conduct initial protocol training with site staff
2. Coordinate the process for completion of study related procedures and tests.
3. Inform primary care physician of subject's interest in the study.
4. Discontinue all excluded medications for potential subjects.
A. 1 and 2 only
B. 1 and 4 only
C. 2 and 3 only
D. 3 and 4 only - ✔✔A
Reason: Prior to screening subjects, site staff should be appropriately trained on the
protocol and study-related procedures. In addition, the role of the CRC is to coordinate
study-related testing with other departments. Informing the subject's primary care
physician of the subject's interest in the study is suggested by ICH-GCP, but only with
the consent of the subject, which is not presented in Option C. Finally, Option D is
incorrect because it is inappropriate to discontinue medications without informed
consent first being obtained from the subject.
