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ACRP Certified Professional Exam Sample Questions (Q99-Q104):

NEW QUESTION # 99
A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

A. Sponsor
B. QA Department
C. Monitor
D. Data Manager

Answer: C

Explanation:
After data entry into the Electronic Data Capture (EDC) system, the monitor (typically a Clinical Research Associate - CRA) conducts Source Data Verification (SDV). The monitor compares the data entered in the EDC system with the source documents to ensure accuracy, completeness, and consistency. This step is essential for maintaining data integrity and compliance with GCP standards.
GCP guidelines require that monitors verify data accuracy through SDV as part of routine monitoring responsibilities.
"The monitor is responsible for performing Source Data Verification (SDV) to ensure that the data recorded in the EDC system matches the source documents." Objectives:
* Verify data accuracy in clinical trials.
* Ensure compliance with data management protocols.

NEW QUESTION # 100
A monitor identifies multiple deviations from a protocol-defined timeline for study procedures. The monitor is unable to identify proof of PI review and assessment of the deviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What is the purpose of this CAPA?

A. To escalate corrective actions to the regulatory authority
B. To establish a procedure for PI oversight of protocol deviations
C. To determine if the deviations invalidate the data
D. To determine if a protocol amendment is needed

Answer: B

Explanation:
A Corrective and Preventive Action (CAPA) plan is implemented to address deviations and prevent them from recurring. In this context, the purpose of the CAPA is to establish a procedure for the Principal Investigator (PI) to ensure proper oversight of protocol deviations. This ensures that all future deviations are appropriately managed, reviewed, and documented according to GCP standards.
The answer is verified from GCP guidelines which emphasize that CAPA should focus on identifying root causes and establishing processes to prevent future deviations.
"A CAPA plan must address the root cause and implement systematic actions to prevent the recurrence of protocol deviations." Objectives:
* Ensuring PI oversight in protocol adherence
* Maintaining data integrity through systematic corrective actions

NEW QUESTION # 101
A study to determine the effective dose and regimen of a new IP for the treatment of hypothyroidism is considered to be:

A. Phase II
B. Phase IV
C. Phase III
D. Phase I

Answer: A

Explanation:
A Phase II clinical trial is typically conducted to evaluate the efficacy of a drug, determine the optimal dosing regimen, and further assess its safety profile. Since the objective is to establish the effective dose and regimen for hypothyroidism treatment, this clearly falls under Phase II.
GCP guidelines categorize Phase II trials as those aimed at determining efficacy and optimal dosing of investigational products.
"Phase II trials focus on determining the therapeutic efficacy, optimal dosage, and further evaluating the safety of the investigational product." Objectives:
* Identify effective dosing regimens.
* Evaluate therapeutic efficacy for targeted conditions.

NEW QUESTION # 102
Preliminary evidence suggests a low-dose anti-cancer drug given for a short period of time may reduce the risk of developing cancer in patients who are at increased risk for developing cancer. The drug has potentially serious side effects. What is the MOST important question to consider before designing a clinical trial to test this hypothesis?

A. How likely are patients at high risk of cancer going to develop cancer during the study?
B. How willing are current patients to participate in a trial with potentially serious side effects?
C. How does the risk of developing cancer compare to the anticipated side effects from the drug?
D. How effective is the drug at treating patients that have been previously diagnosed with cancer?

Answer: C

Explanation:
Before initiating a clinical trial with a drug that has potentially serious side effects, it is essential to evaluate the risk-benefit ratio. The primary consideration is whether the potential benefits (reduced cancer risk) outweigh the risks (serious side effects). This assessment is fundamental to ethical clinical trial design.
The answer is verified as per GCP and ethical guidelines, which require a thorough assessment of risk versus benefit before conducting human trials.
"An assessment of potential benefits versus risks is a fundamental principle in the ethical design of clinical trials, especially when potential adverse effects are severe." Objectives:
* Ensure ethical considerations in trial design.
* Assess the potential harm versus benefit to participants.

NEW QUESTION # 103
Which of the following is a conflict of interest for a PI conducting a study?

A. A PI who is a key opinion leader, writes the protocol
B. A PI who receives payment for the study
C. A PI that votes on the IRB/IEC approval of the protocol
D. A PI that presents at an investigator meeting

Answer: C

Explanation:
A Principal Investigator (PI) who is involved in voting on the IRB/IEC approval of their own protocol is considered to have a conflict of interest. The IRB/IEC must be independent and impartial when reviewing research proposals. Allowing the PI to vote on their own study compromises the ethical review process. To maintain unbiased decision-making, PIs must recuse themselves from such votes.
GCP guidelines emphasize the importance of avoiding conflicts of interest in the IRB/IEC decision-making process to maintain objectivity and ethical standards.
"A PI should not participate in voting or decision-making processes regarding the approval of their own study to avoid conflicts of interest." Objectives:
* Maintain impartiality in ethical review.
* Prevent conflicts of interest during IRB/IEC processes.

NEW QUESTION # 104
......

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ACRP Certified Professional Exam Sample Questions (Q99-Q104):

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