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ACRP Certified Professional Exam Sample Questions (Q124-Q129):

NEW QUESTION # 124
An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:

A. Regulatory authority expert advisors.
B. Investigators participating in the trial.
C. Independent qualified individuals.
D. Executive board members.

Answer: C

Explanation:
Interim analysis should be reviewed by independent qualified individuals, such as members of a Data Safety Monitoring Board (DSMB) or Independent Data Monitoring Committee (IDMC). This ensures that the analysis is unbiased and that decisions regarding continuation, modification, or termination of the trial are made objectively.
GCP guidelines emphasize that interim data should be reviewed by an independent committee to prevent bias and ensure participant safety.
"Interim analyses should be conducted by independent experts to maintain objectivity and safeguard trial integrity." Objectives:
* Maintain impartiality during interim analysis.
* Ensure unbiased decision-making regarding trial continuation.

NEW QUESTION # 125
All of the following are examples of what monitors review EXCEPT:

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

Answer: B

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 # 126
At a close-out visit, which document should be retained only at the site?

A. Treatment allocation
B. Subject identification code list
C. IP accountability
D. Final trial close-out monitoring report

Answer: B

Explanation:
The subject identification code list, which links the participant's unique code to their personal information, must be retained only at the site. This list ensures confidentiality and is necessary for identifying participants during follow-up. It is not shared with the sponsor to protect participant privacy.
GCP guidelines mandate that the subject identification code list remains at the site to ensure confidentiality and compliance with data protection regulations.
"The subject identification code list must be securely stored at the site to maintain participant confidentiality." Objectives:
* Safeguard participant confidentiality.
* Maintain compliance with data protection policies.

NEW QUESTION # 127
The investigator/institution should permit:

A. Monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).
B. Monitoring and auditing by the appropriate regulatory authority(ies), and inspection by the sponsor.
C. Monitoring and inspection by the appropriate regulatory authority(ies), and auditing by the sponsor.
D. Monitoring and inspection by the sponsor, and auditing by the appropriate regulatory authority(ies).

Answer: C

Explanation:
The investigator and institution must allow both monitoring and inspection by the appropriate regulatory authorities and auditing by the sponsor. This dual oversight ensures that the trial complies with regulatory standards and sponsor requirements, thereby maintaining the integrity and validity of the data.
GCP guidelines specify that regulatory authorities have the right to inspect, while sponsors typically conduct audits to verify compliance and data quality.
"The institution should permit monitoring and inspection by regulatory authorities and auditing by the sponsor to ensure compliance with GCP and protocol adherence." Objectives:
* Facilitate monitoring and inspection for compliance.
* Ensure trial data integrity and quality assurance.

NEW QUESTION # 128
In a quality management system, in which category do risk reduction activities belong?

A. Risk Control
B. Risk Communication
C. Risk Evaluation
D. Risk Review

Answer: A

Explanation:
Risk reduction activities fall underRisk Controlwithin a Quality Management System (QMS). Risk control involves implementing measures to reduce identified risks to an acceptable level, including corrective actions, preventive measures, and continuous monitoring. It aims to mitigate potential negative impacts on trial integrity and participant safety.
GCP guidelines highlight that risk control encompasses actions taken to minimize the likelihood and impact of identified risks.
"Risk control is the process of implementing measures to mitigate risks identified during the risk assessment phase." Objectives:
* Implement effective risk management strategies.
* Ensure proactive risk mitigation in clinical trials.

NEW QUESTION # 129
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Ava Bailey Ava Bailey

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