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ACRP Certified Professional Exam Sample Questions (Q125-Q130):

NEW QUESTION # 125
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 effective is the drug at treating patients that have been previously diagnosed with cancer?
C. How willing are current patients to participate in a trial with potentially serious side effects?
D. How likely are patients at high risk of cancer going to develop cancer during the study?

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 # 126
Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

A. Coordinator
B. Monitor
C. Investigator
D. Sponsor

Answer: C

Explanation:
The Principal Investigator (PI) is responsible for ensuring that all site staff involved in the study are adequately trained, even if they were unable to attend the Site Initiation Visit (SIV). This responsibility includes organizing training sessions or providing relevant training materials to maintain consistency and compliance with study protocols.
According to GCP guidelines, the PI must ensure that all staff members involved in the trial are adequately informed and trained on their specific responsibilities.
"The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions." Objectives:
* Maintain consistent training for all clinical staff.
* Ensure compliance with study procedures.

NEW QUESTION # 127
Which of the following should be reviewed and evaluated by qualified experts to assess implications for the safety of the trial subjects?

A. PI roles and responsibilities
B. Sample collection storage, disposal, and shipment requirements
C. Emerging animal toxicological and clinical data
D. Project feasibility considerations

Answer: C

Explanation:
Qualified experts should evaluate emerging animal toxicological and clinical data to assess potential safety implications for trial subjects. These data are critical in identifying potential risks, adverse effects, or safety concerns before exposing human subjects to the investigational product. Early detection of safety issues through expert evaluation helps protect participant well-being.
GCP guidelines stress the importance of expert assessment of preclinical and clinical data to identify risks and ensure participant safety.
"Emerging toxicological and clinical data should be carefully reviewed by qualified experts to identify safety concerns before clinical use." Objectives:
* Ensure participant safety through expert data analysis.
* Identify potential safety risks early in the trial process.

NEW QUESTION # 128
The investigator/institution should permit:

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

Answer: D

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 # 129
Who should vote during the IRB/IEC review and discussion process?

A. All IRB/IEC members
B. All members who were involved in the review and discussion
C. All members who were involved in the review and discussion and non-member experts
D. All IRB/IEC members and non-member experts

Answer: B

Explanation:
During the IRB/IEC review process, only members who actively participated in the review and discussion are eligible to vote. This ensures that votes are cast by those who are adequately informed about the study and can make an educated decision. Non-member experts may participate in discussions but do not have voting rights.
GCP guidelines state that voting rights in IRB/IEC meetings are limited to members who have thoroughly reviewed and discussed the study, maintaining unbiased and informed decision-making.
"Only IRB/IEC members who were involved in the review and discussion should participate in the voting process." Objectives:
* Ensure informed voting in ethical review processes.
* Maintain integrity and objectivity in IRB/IEC decisions.

NEW QUESTION # 130
......

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ACRP-CP Test Pdf | Reliable ACRP-CP Test Cram

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ACRP Certified Professional Exam Sample Questions (Q125-Q130):

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