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ACRP Certified Professional Exam Sample Questions (Q82-Q87):

NEW QUESTION # 82
Who takes responsibility for initiating a clinical trial?

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

Answer: D

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 # 83
During a mid-study sponsor audit of a clinical trial, the auditor notices that all of the protocol-required subject drug dosing diaries were incomplete. The effect of this will be the inability to:

A. Conduct safety analysis.
B. Evaluate study data.
C. Verify compliance with IP regimen.
D. Validate protocol endpoints.

Answer: C

Explanation:
Subject drug dosing diaries are essential for documenting adherence to the investigational product (IP) regimen. Incomplete or missing diaries compromise the ability to verify whether subjects followed the dosing schedule, which directly affects the trial's data integrity and the reliability of efficacy and safety assessments.
GCP guidelines stress the importance of maintaining accurate and complete dosing records to verify subject compliance with the protocol.
"Accurate documentation of dosing is essential to verify compliance with the investigational product regimen and ensure data accuracy." Objectives:
* Maintain accurate IP administration records.
* Ensure compliance monitoring throughout the study.

NEW QUESTION # 84
Which entity has ultimate responsibility over the conduct of the multi-center clinical trial?

A. Sponsor-Investigator
B. IRB/IEC
C. Regulatory authority
D. CRO

Answer: A

Explanation:
In a multi-center clinical trial, the Sponsor-Investigator holds ultimate responsibility for the overall conduct of the study. This includes ensuring compliance with the protocol, maintaining data integrity, and overseeing all participating sites. The Sponsor-Investigator must ensure that each site follows the same procedures and standards to maintain consistency across the trial.
According to GCP guidelines, the Sponsor-Investigator must take responsibility for all aspects of a multi- center trial, including site coordination and data management.
"The Sponsor-Investigator assumes ultimate responsibility for the conduct of a multi-center clinical trial, ensuring protocol compliance and data consistency." Objectives:
* Maintain accountability across multi-center sites.
* Ensure uniformity in trial conduct.

NEW QUESTION # 85
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. Sponsor
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 # 86
Which of the following should be considered when implementing a risk-based monitoring plan?

A. Centralized monitoring must be incorporated in any trials.
B. 100% source document review is mandatory.
C. Monitoring schedule must be pre-defined in the monitoring plan.
D. On-site monitoring frequency may change depending on the quality of the data.

Answer: D

Explanation:
Risk-based monitoring focuses on adapting the frequency and intensity of on-site visits based on data quality and site performance. If the data is consistently accurate and reliable, the monitoring frequency may be reduced. Conversely, if issues are identified, more frequent monitoring may be necessary.
GCP guidelines emphasize a flexible approach to monitoring, allowing adjustments based on the risk profile and quality of data collected.
"Risk-based monitoring involves adapting the frequency of on-site visits according to the quality of the data and the site's compliance level." Objectives:
* Implement a dynamic monitoring strategy.
* Enhance efficiency while maintaining data integrity.

NEW QUESTION # 87
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ACRP-CP Exam Guide Materials - Valid ACRP-CP Test Preparation

Valid ACRP-CP Test Preparation & New ACRP-CP Mock Test

ACRP Certified Professional Exam Sample Questions (Q82-Q87):

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