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ACRP Certified Professional Exam Sample Questions (Q25-Q30):

NEW QUESTION # 25
The investigator/institution should permit:

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

Answer: A

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 # 26
Which of the following is a conflict of interest for a PI conducting a study?

A. A PI that votes on the IRB/IEC approval of the protocol
B. A PI who is a key opinion leader, writes the protocol
C. A PI who receives payment for the study
D. A PI that presents at an investigator meeting

Answer: A

Explanation:
A Principal Investigator (PI) who is involved in voting on the IRB/IEC approval of their own protocol is considered to have a conflict of interest. The IRB/IEC must be independent and impartial when reviewing research proposals. Allowing the PI to vote on their own study compromises the ethical review process. To maintain unbiased decision-making, PIs must recuse themselves from such votes.
GCP guidelines emphasize the importance of avoiding conflicts of interest in the IRB/IEC decision-making process to maintain objectivity and ethical standards.
"A PI should not participate in voting or decision-making processes regarding the approval of their own study to avoid conflicts of interest." Objectives:
* Maintain impartiality in ethical review.
* Prevent conflicts of interest during IRB/IEC processes.

NEW QUESTION # 27
In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:

A. One member whose primary area of interest is in the same scientific area.
B. One member who is independent of the institution/trial site.
C. A total of five members.
D. One member of the site's QA group.

Answer: B

Explanation:
The IRB/IEC should include at least one member who is not affiliated with the institution or trial site to ensure impartiality and objectivity in the review process. This helps maintain ethical oversight without internal biases influencing the decisions.
This answer is based on ICH E6(R2) GCP guidelines, which mandate the inclusion of non-affiliatedmembers to uphold the integrity of the ethical review process.
"The IRB/IEC should include at least one member who is not associated with the institution to provide an unbiased perspective." Objectives:
* Maintain impartiality in ethical review.
* Ensure diverse representation within the IRB/IEC.

NEW QUESTION # 28
Who determines the age of assent for pediatric studies?

A. IRB/IEC
B. Sponsor
C. Parent
D. PI

Answer: A

Explanation:
The IRB/IEC determines the age at which a child is considered capable of providing assent for participation in a clinical trial. This decision is based on local regulations, cultural considerations, and the child's ability to understand the trial's risks and benefits. The age of assent may vary between jurisdictions and is subject to ethical considerations specific to pediatric research.
GCP guidelines emphasize that the IRB/IEC is responsible for setting the criteria for obtaining assent from minors based on ethical and regulatory frameworks.
"The IRB/IEC is responsible for determining the age and circumstances under which pediatric assent is required, considering the child's comprehension level." Objectives:
* Ensure appropriate ethical practices in pediatric research.
* Align with local regulatory requirements for assent.

NEW QUESTION # 29
A study to determine the effective dose and regimen of a new IP for the treatment of hypothyroidism is considered to be:

A. Phase III
B. Phase II
C. Phase I
D. Phase IV

Answer: B

Explanation:
A Phase II clinical trial is typically conducted to evaluate the efficacy of a drug, determine the optimal dosing regimen, and further assess its safety profile. Since the objective is to establish the effective dose and regimen for hypothyroidism treatment, this clearly falls under Phase II.
GCP guidelines categorize Phase II trials as those aimed at determining efficacy and optimal dosing of investigational products.
"Phase II trials focus on determining the therapeutic efficacy, optimal dosage, and further evaluating the safety of the investigational product." Objectives:
* Identify effective dosing regimens.
* Evaluate therapeutic efficacy for targeted conditions.

NEW QUESTION # 30
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