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ACRP Certified Professional Exam Sample Questions (Q52-Q57):

NEW QUESTION # 52
What is a systematic and independent examination of trial-related activities and documents todetermine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsors, SOPs, GCP, and the applicable regulatory requirements?

A. Site qualification
B. Inspection
C. Routine monitoring
D. Audit

Answer: D

Explanation:
An audit is a systematic and independent examination of trial-related activities and documents. Its purpose is to determine whether the study was conducted in compliance with the protocol, GCP, and regulatory requirements. Audits are usually performed by the sponsor or an independent auditor and focus on evaluating data integrity and trial conduct.
GCP guidelines define an audit as a thorough examination to ensure adherence to protocol and regulatory requirements.
"An audit is a systematic and independent examination of trial-related activities to verify compliance with the protocol and regulatory standards." Objectives:
Ensure compliance and data integrity.
Identify any gaps in trial conduct.

NEW QUESTION # 53
Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?

A. CRO
B. Investigator
C. Sponsor
D. CRC

Answer: C

Explanation:
The sponsor is responsible for ensuring that agreements are in place with all involved parties (including investigators and institutions) to grant direct access to trial-related source documents. This is crucial for monitoring, auditing, and inspection purposes, ensuring transparency and compliance with regulatory requirements.
According to GCP guidelines, the sponsor must establish agreements to secure direct access to trial data for verification and compliance checks.
"The sponsor should ensure that agreements are in place to permit direct access to source data and documents for monitoring and inspection." Objectives:
* Maintain compliance with regulatory requirements.
* Facilitate data verification and quality assurance.

NEW QUESTION # 54
During a monitoring visit, a CRA notices that a piece of equipment required for the study needs to be serviced. Who is responsible for addressing this problem?

A. PI
B. Sponsor
C. CRC
D. CRA

Answer: A

Explanation:
The Principal Investigator (PI) is responsible for ensuring that all equipment used in the clinical trial is properly maintained and serviced. If a monitor (CRA) identifies equipment that needs servicing, the PI must take immediate action to ensure the equipment is in working order to maintain the quality and integrity of the study data.
GCP guidelines emphasize the PI's responsibility to ensure that all equipment used in the study is functional, properly calibrated, and serviced as needed.
"The PI is responsible for maintaining the functionality and calibration of study-related equipment to ensure accurate data collection." Objectives:
Maintain equipment functionality to ensure data accuracy.
Ensure proper maintenance as part of site management.

NEW QUESTION # 55
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. Investigator's Brochure
B. Standard Operating Procedure
C. Clinical Monitoring Plan
D. Data & Safety Monitoring Plan

Answer: B

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 # 56
The sponsor calls the site and informs the research team that they have decided to temporarily suspend the study. What step should the research team take FIRST?

A. Inform the IRB/IEC of the study closure.
B. Inform the monitor of the termination of the study.
C. Inform participant and assure proper care is provided.
D. Schedule participant for early termination visit.

Answer: C

Explanation:
When a study is temporarily suspended, the primary responsibility of the research team is to ensure the ongoing care and safety of the enrolled participants. Participants must be informed about the suspension and assured that their health and safety will continue to be monitored.
GCP guidelines prioritize the safety and well-being of participants, which must be maintained even during a temporary suspension.
"In the event of a study suspension, the first priority is to inform the participants and ensure that appropriate care and monitoring are continued." Objectives:
* Protect participant safety during study suspension.
* Maintain clear communication with study participants.

NEW QUESTION # 57
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ACRP Certified Professional Exam Sample Questions (Q52-Q57):

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