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ACRP Certified Professional Exam Sample Questions (Q66-Q71):

NEW QUESTION # 66
Who determines the age of assent for pediatric studies?

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

Answer: B

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 # 67
While reviewing a new protocol, a PI realizes a specialized laboratory test is required that the local hospital does not perform. The PI locates a laboratory that performs the specialized test and retains their services.
Responsibility for ensuring the laboratory retained is qualified for this trial-related task lies with the:

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

Answer: C

Explanation:
The Principal Investigator (PI) is responsible for ensuring that any laboratory used for trial-related testing is appropriately qualified and certified. This includes verifying the laboratory's accreditation, quality control procedures, and ability to perform the required tests accurately. The PI must document the qualification process to ensure compliance with GCP and protocol requirements.
GCP guidelines state that the investigator is responsible for selecting and verifying the qualification of laboratories used in the study.
"The PI must ensure that any laboratory involved in the trial is properly qualified and capable of performing the specified tests according to protocol requirements." Objectives:
* Maintain quality control in laboratory testing.
* Ensure the accuracy and reliability of test results.

NEW QUESTION # 68
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. Routine monitoring
B. Audit
C. Site qualification
D. Inspection

Answer: B

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 # 69
A protocol amendment is needed to collect additional data from a participant's medical record. When can the research team begin collecting the additional data?

A. When the need for the additional data is discovered
B. As soon as the protocol amendment is submitted to the IRB/IEC
C. After the original planned data collection is completed
D. After the protocol amendment is approved by the IRB/IEC

Answer: D

Explanation:
The research team must wait until the protocol amendment is reviewed and approved by the IRB/IEC before collecting any additional data. This ensures that any changes to the data collection process have undergone ethical review and comply with regulatory requirements. Collecting data without IRB/IEC approval would be a violation of Good Clinical Practice (GCP).
GCP guidelines clearly state that any changes to the protocol, including additional data collection, must be approved by the IRB/IEC before implementation.
"Any amendment that affects participant data collection must receive IRB/IEC approval before the change is implemented." Objectives:
* Maintain compliance with ethical standards.
* Protect participants' rights and data integrity.

NEW QUESTION # 70
Who should vote during the IRB/IEC review and discussion process?

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

Answer: A

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 # 71
......

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New Exam ACRP-CP Actual Tests | High Pass-Rate ACRP-CP: ACRP Certified Professional Exam 100% Pass

Reliable ACRP-CP Test Dumps - ACRP-CP Passguide

ACRP Certified Professional Exam Sample Questions (Q66-Q71):

Quiz 2025 ACRP ACRP-CP Latest Exam Actual Tests

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