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ACRP Certified Professional Exam Sample Questions (Q121-Q126):

NEW QUESTION # 121
Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A. Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
B. A monitoring report that identifies deviation from the approved protocol.
C. A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
D. Training records of site personnel on study protocol, and their study-related duties and functions.

Answer: D

NEW QUESTION # 122
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 does the risk of developing cancer compare to the anticipated side effects from the drug?
B. How likely are patients at high risk of cancer going to develop cancer during the study?
C. How willing are current patients to participate in a trial with potentially serious side effects?
D. How effective is the drug at treating patients that have been previously diagnosed with cancer?

Answer: A

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 # 123
A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

A. Data & Safety Monitoring Plan
B. Investigator's Brochure
C. Clinical Monitoring Plan
D. Standard Operating Procedure

Answer: D

Explanation:
The Standard Operating Procedure (SOP) outlines the process for shipping, storing, mixing, and transferring the investigational product (IP) between locations. SOPs ensure that all steps are consistently followed and documented, maintaining the integrity and quality of the IP throughout the handling process. This is critical for maintaining compliance with Good Clinical Practice (GCP) and ensuring patient safety.
GCP guidelines specify that SOPs should cover the handling, transfer, and storage of investigational products to ensure quality control.
"SOPs provide detailed guidance on the handling and transfer of investigational products to ensure consistency and compliance." Objectives:
* Maintain the integrity of IP during transport and handling.
* Ensure compliance through standardized procedures.

NEW QUESTION # 124
While reviewing reports of data completion, the sponsor notices low retention rates at many participating sites. What is an appropriate FIRST action for the sponsor to take?

A. Require participants to provide documented reason for withdrawal.
B. Submit revised ICFs to the IRB/IEC with increased compensation for participants.
C. Meet with the site staff to understand their workflows and to review retention strategies.
D. Interview participants who have dropped out.

Answer: C

Explanation:
Meeting with site staff to understand workflows and retention strategies is the most practical first step. By engaging with the team, the sponsor can identify potential issues affecting retention, such as site-related factors, participant burden, or protocol complexities. Addressing these issues collaboratively can improve retention without needing major protocol changes.
GCP guidelines recommend assessing and understanding site-specific challenges before making procedural changes or protocol amendments.
"Engaging with site staff to discuss retention issues helps identify root causes and develop practical solutions." Objectives:
* Improve participant retention through collaboration.
* Identify and address site-specific challenges.

NEW QUESTION # 125
Who ensures information regarding payments to subjects is documented in a written consent form?

A. Coordinator
B. IRB/IEC
C. PI
D. Sponsor

Answer: B

Explanation:
The IRB/IEC is responsible for reviewing and approving the consent form, which must include any information about payments to participants. This ensures transparency and ethical compliance regarding compensation.
The answer is verified according to GCP guidelines, which mandate IRB/IEC review of consentforms, including payment details.
"IRB/IEC must ensure that the informed consent process is thorough and includes disclosure of any compensation or payment to participants." Objectives:
* Guaranteeing informed consent quality
* Ensuring transparency about participant payments

NEW QUESTION # 126
......

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