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ACRP-CP Test Questions - ACRP-CP Test Torrent & ACRP-CP Latest Torrents

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ACRP Certified Professional Exam Sample Questions (Q93-Q98):

NEW QUESTION # 93
Which of the following statements is TRUE about an EDC system?

A. A separate workstation should be made available for the monitor.
B. There should be an audit trail to track data entries, deletions, and changes.
C. IRB/IEC approval is required before the use of the computerized system.
D. The eCRF should be an exact page-by-page replica of the paper CRF.

Answer: B

Explanation:
An Electronic Data Capture (EDC) system must include an audit trail to ensure data integrity. This audit trail records every data entry, modification, and deletion along with timestamps and user identification. It is a critical feature for maintaining traceability and accountability in clinical research, allowing for the reconstruction of data changes and ensuring compliance with Good Clinical Practice (GCP).
GCP guidelines mandate that electronic data systems used in clinical trials must maintain an audit trail to ensure data integrity and traceability.
"An audit trail is essential in an EDC system to document all data entries, changes, and deletions to maintain data integrity." Objectives:
* Ensure data integrity through traceable record-keeping.
* Maintain compliance with regulatory standards.

NEW QUESTION # 94
Who should vote during the IRB/IEC review and discussion process?

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

Answer: D

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 # 95
Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?

A. The regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.
B. The CRC is responsible for identifying the relationship of an SAE to the IP.
C. The sponsor is responsible for overseeing any delegated activities to a CRO and ensuring that the delegation of these activities is documented.
D. The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.

Answer: C

Explanation:
The sponsor holds the responsibility for overseeing any activities delegated to a Contract Research Organization (CRO). This includes ensuring that all delegated tasks are clearly documented and that the CRO performs them according to regulatory standards and the study protocol.
GCP guidelines state that while the sponsor may delegate tasks to a CRO, the ultimate responsibility for the trial's conduct remains with the sponsor.
"The sponsor retains responsibility for overseeing any delegated tasks to the CRO and must ensure that these responsibilities are appropriately documented." Objectives:
* Clarify delegation of duties in clinical trials.
* Maintain sponsor oversight for regulatory compliance.

NEW QUESTION # 96
Who on the local site research study team is accountable for the unblinding documentation of IP?

A. Regulatory manager
B. CRC
C. Pharmacist
D. PI

Answer: D

Explanation:
The Principal Investigator (PI) is ultimately responsible for maintaining and documenting any unblinding events related to the investigational product (IP). This accountability ensures that any instance where the blind is broken is properly justified, documented, and reported to maintain trial integrity.
GCP guidelines state that the PI must oversee the unblinding process and ensure proper documentation to protect the validity of the trial data.
"The PI is responsible for ensuring that any unblinding of the investigational product is adequately documented and reported according to protocol." Objectives:
* Maintain the integrity of blinded studies.
* Properly document unblinding incidents.

NEW QUESTION # 97
Which of the following reports should be retained in participant charts?

A. DSMB/IDMC reports
B. Safety reports
C. IRB/IEC progress reports
D. Lab reports

Answer: D

Explanation:
Lab reports contain individual participant data relevant to their health status and the study's outcomes. These reports are essential for verifying subject safety and evaluating the effects of the investigational product (IP).
Therefore, they must be retained in the participant's medical records.
According to GCP guidelines, participant charts must include laboratory data as part of the essential documents to ensure accurate and complete clinical records.
"Lab reports must be maintained as part of the participant's chart for safety monitoring and data verification." Objectives:
* Maintain comprehensive medical records for each participant.
* Ensure availability of clinical data for audit and review.

NEW QUESTION # 98
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