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ACRP Certified Professional Exam Sample Questions (Q123-Q128):

NEW QUESTION # 123
A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?

A. Develop a monitoring plan
B. Conduct routine investigators' meetings
C. Establish a DSMB/IDMC
D. Draft a CAPA plan

Answer: C

Explanation:
A Data Safety Monitoring Board (DSMB) or Independent Data Monitoring Committee (IDMC) is established to review ongoing trial data at regular intervals. The DSMB evaluates safety, progress, and efficacy endpoints and makes recommendations to continue, modify, or terminate the study based on interim data. This independent oversight helps ensure participant safety and data integrity throughout the trial.
GCP guidelines recommend forming a DSMB for studies that involve high risks or long durations, ensuring continuous safety monitoring.
"The DSMB is responsible for the periodic review of accumulating data and providing recommendations regarding trial continuation, modification, or termination." Objectives:
* Ensure ongoing safety evaluation.
* Facilitate objective decisions on trial continuation.

NEW QUESTION # 124
A hospital site is being considered for a trial that requires the IP refrigerator to be continuously monitored using the sponsor-provided Wi-Fi-enabled thermometer. The hospital's Wi-Fi connectivity is inconsistent.
During site selection, how should the CRA proceed?

A. Before accepting this site, ensure the refrigerator is calibrated and functioning properly.
B. Accept this site and implement and maintain QA and QC systems with written SOPs.
C. Accept this site and plan to undertake routine safety evaluations of the IP.
D. Before accepting this site, report the risk to the trial sponsor and await their decision.

Answer: D

Explanation:
Since the Wi-Fi connectivity is inconsistent, the CRA must assess the risk and report it to the trial sponsor for a decision. Accepting the site without proper risk evaluation may compromise the monitoring of the investigational product (IP) storage conditions, affecting trial integrity.
The answer follows GCP guidelines that emphasize assessing potential risks during site selection and involving the sponsor when critical issues arise.
"When faced with site-specific issues that may affect data integrity or product safety, the CRA should consult with the sponsor before making a final decision." Objectives:
* Ensuring proper site selection
* Managing potential risks proactively

NEW QUESTION # 125
The PI may assign responsibility for IP accountability to the pharmacist provided they are:

A. Under the supervision of the PI.
B. Approved by the IRB/IEC.
C. An employee of the institution.
D. Licensed to practice medicine.

Answer: A

Explanation:
The Principal Investigator (PI) can delegate the responsibility for investigational product (IP) accountability to a pharmacist as long as the pharmacist operates under the PI's supervision. This ensures that the pharmacist's actions remain compliant with the protocol and regulatory requirements.
According to GCP guidelines, the PI retains overall responsibility for IP management, even when tasks are delegated to other qualified staff members.
"The investigator may delegate IP management responsibilities to a pharmacist, provided the pharmacist works under the PI's direct supervision." Objectives:
* Maintain accountability for investigational products.
* Ensure proper delegation of IP responsibilities.

NEW QUESTION # 126
An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?

A. Discontinue current subjects from the study and monitor subjects for any anticipated safety events.
B. Update the IB to add the risk of infection and submit to the sponsor for approval.
C. Add the risk of infection to the ICF and submit to the IRB/IEC for review.
D. Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.

Answer: D

Explanation:
The investigator must promptly notify the sponsor about the observed safety concerns and the decision to stop the IP administration. This constitutes a protocol deviation that must be reported tothe IRB/IEC for ethical oversight. It is essential to document the deviation accurately and seek guidance on whether to continue or modify the study procedures.
GCP guidelines require that significant deviations impacting participant safety be reported to both the sponsor and the IRB/IEC for appropriate review and action.
"Significant safety-related deviations must be reported promptly to the sponsor and IRB/IEC to ensure proper oversight and participant protection." Objectives:
Ensure prompt reporting of safety concerns.
Maintain compliance with ethical oversight requirements.

NEW QUESTION # 127
All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:

A. Identifying potential study risks.
B. Assessing risk based on study impact.
C. Documenting all possible risk scenarios.
D. Controlling risk by setting thresholds of risk acceptability.

Answer: C

Explanation:
While identifying potential risks, assessing them based on their impact, and setting risk acceptability thresholds are integral parts of a risk management approach, documenting every possible risk scenario is impractical and unnecessary. Instead, focus should be on identifying and managing the most significant and likely risks that could affect the study's quality and safety.
GCP guidelines emphasize identifying, assessing, and controlling critical risks rather than exhaustively documenting all hypothetical scenarios.
"Effective risk management involves identifying key risks, evaluating their impact, and setting control measures, rather than documenting every possible risk." Objectives:
* Implement practical and targeted risk management strategies.
* Focus on significant and likely risks rather than hypothetical ones.

NEW QUESTION # 128
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