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

NEW QUESTION # 123
A site is starting up a Phase III trial. They have received IRB/IEC approval and have scheduled the SIV. The site cannot begin enrolling subjects until:

A. A signed clinical trial agreement between the site and sponsor is in place.
B. The DSMB meets and the first DSMB meeting report has been issued.
C. The CRA has performed source document review and verification at the site.
D. The site receives approval from the medical monitor to begin enrolling.

Answer: A

Explanation:
Before a clinical trial site can begin enrolling participants, there must be a signed clinical trial agreement (CTA) between the site and the sponsor. This agreement outlines the responsibilities, financial arrangements, and expectations between both parties, ensuring that the trial is conducted in compliance with regulatory and ethical standards.
GCP guidelines require that a formal agreement be in place before trial initiation to protect the rights and obligations of both the sponsor and the site.
"Before subject enrollment can commence, the sponsor and site must finalize a clinical trial agreement, establishing legal and ethical commitments." Objectives:
* Ensure proper contractual arrangements before trial initiation.
* Protect legal rights and obligations of involved parties.

NEW QUESTION # 124
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. QA Department
B. Data Manager
C. Monitor
D. Sponsor

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 # 125
Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?

A. Ensure there is an accompanying written record that describes the consent process.
B. Ensure submission of a data management plan to the regulatory authorities.
C. Conduct annual reviews of the protocol and accompanying study documents.
D. Develop a plan that describes the monitoring approach for a clinical study.

Answer: D

Explanation:
Developing a monitoring plan that outlines the approach to quality assurance is essential for maintaining data integrity throughout the clinical trial. This plan helps identify critical data points, risk-based monitoring strategies, and procedures for detecting and correcting data discrepancies. It ensures that the study data collected is accurate, complete, and verifiable.
GCP guidelines emphasize the importance of a monitoring plan to safeguard the quality and integrity of study data.
"The sponsor should develop a comprehensive monitoring plan to ensure the accuracy, completeness, and consistency of trial data." Objectives:
* Maintain high-quality data through structured monitoring.
* Identify potential risks and address them proactively.

NEW QUESTION # 126
Who takes responsibility for initiating a clinical trial?

A. Sponsor
B. IRB/IEC
C. CRO
D. Investigator

Answer: A

Explanation:
The sponsor is responsible for initiating a clinical trial. This involves developing the protocol, securing funding, selecting study sites, and obtaining regulatory approvals. The sponsor also oversees the conduct of the trial to ensure compliance with GCP and regulatory requirements.
According to GCP guidelines, the sponsor is the entity that initiates, manages, and finances the clinical investigation.
"The sponsor is responsible for initiating, managing, and financing the clinical trial, including protocol development and site selection." Objectives:
* Understand the sponsor's role in trial initiation.
* Ensure compliance from the outset of the study.

NEW QUESTION # 127
All of the following are examples of what monitors review EXCEPT:

A. Documentation in the participant's medical record of study drug administration.
B. The signed ICF retained in the participant's study file.
C. Potential patient medical records for eligibility prior to the informed consent process.
D. Regulatory binder which includes copies of current certifications for all laboratories.

Answer: C

Explanation:
Monitors are responsible for reviewing documents that pertain to study conduct and data integrity,including regulatory binders, informed consent forms (ICFs), and documentation of study drug administration.
However, reviewing potential patient medical records for eligibility prior to the informed consent process is not part of a monitor's responsibilities, as this would violate patient confidentiality and GCP standards.
According to GCP guidelines, monitors should ensure compliance with the protocol and data integrity but should not access non-consented patient records.
"Monitors should verify that only enrolled and consented subjects' data are reviewed, ensuring compliance with privacy regulations." Objectives:
* Understand the scope of monitoring responsibilities.
* Protect patient confidentiality during the monitoring process.

NEW QUESTION # 128
......

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