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2025 ACRP-CP Valid Test Pdf: ACRP Certified Professional Exam–Unparalleled ACRP-CP 100% Pass Quiz

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ACRP Certified Professional Exam Sample Questions (Q88-Q93):

NEW QUESTION # 88
After the completion or termination of a clinical trial, who should store the enrollment log?

A. PI
B. Regulatory authority
C. CRO
D. Sponsor

Answer: A

Explanation:
The Principal Investigator (PI) is responsible for maintaining and securely storing essential documents, including the enrollment log, after the completion or termination of a clinical trial. This ensures that all participant-related records are retained for audit or inspection as per regulatory requirements.
This answer is consistent with GCP guidelines, which specify that the PI is accountable for retaining essential trial documents at the study site.
"The investigator should maintain records of trial participants, including the enrollment log, as part of the essential documents for trial conduct." Objectives:
* Maintain data integrity and compliance with record-keeping requirements.
* Ensure secure and accessible storage of participant information.

NEW QUESTION # 89
A study protocol must contain which of the following elements?

A. Data management plan
B. Description of statistical methods
C. Participant reimbursement details
D. Chemical structure of the IP

Answer: B

Explanation:
A clinical study protocol must include a clear description of the statistical methods to be used in analyzing the collected data. This ensures that the analysis plan is predefined, unbiased, and statistically sound. The statistical methodology must address how the primary and secondary endpoints will be evaluated.
GCP guidelines require that the protocol clearly outlines statistical methods to ensure accurate and unbiased analysis of trial data.
"The protocol should include a detailed description of the statistical methods employed to ensure the validity of the trial results." Objectives:
* Maintain transparency in data analysis.
* Ensure scientific rigor in evaluating study outcomes.

NEW QUESTION # 90
A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?

A. The IRB/IEC must approve the transfer of duties to a CRO.
B. Any trial-related duties can be documented as transferred by verbal agreement.
C. Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
D. All duties transferred to a CRO should be specified in writing.

Answer: D

Explanation:
When a sponsor transfers specific tasks to a Contract Research Organization (CRO), it must be documented in writing. This formal documentation clearly delineates responsibilities and ensures that both parties are aware of their roles and obligations. Verbal agreements are not sufficient forregulatory compliance.
ICH E6(R2) GCP guidelines mandate that all delegated tasks must be documented formally to ensure clarity and compliance.
"The sponsor should document in writing any responsibilities transferred to a CRO to ensure clear delineation of roles." Objectives:
* Maintain clear documentation of delegated tasks.
* Ensure compliance with regulatory standards.

NEW QUESTION # 91
Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?

A. Quarantine IP without registering in IWRS and request replacement from sponsor.
B. Dispose of IP and request replacement from sponsor.
C. Register IP in IWRS, quarantine and notify sponsor of the excursion.
D. Register IP in IWRS and continue with subject allocation.

Answer: C

Explanation:
If a temperature-controlled IP has experienced a temperature excursion during transport, the appropriate action is to register the IP in the Interactive Web Response System (IWRS), quarantine it to prevent use, and immediately notify the sponsor. This procedure ensures that the IP is not used until the sponsor evaluates its stability and suitability.
GCP guidelines state that any IP affected by a temperature excursion should be quarantined and reported to the sponsor for evaluation.
"Upon identification of a temperature excursion, the IP must be quarantined and reported to the sponsor to determine its usability." Objectives:
* Maintain IP integrity and compliance with storage conditions.
* Follow protocol for managing temperature excursions.

NEW QUESTION # 92
A hospital site is being considered for a trial that requires the IP refrigerator to be continuously monitored using the sponsor-provided Wi-Fi-enabled thermometer. The hospital's Wi-Fi connectivity is inconsistent.
During site selection, how should the CRA proceed?

A. Before accepting this site, report the risk to the trial sponsor and await their decision.
B. Accept this site and implement and maintain QA and QC systems with written SOPs.
C. Accept this site and plan to undertake routine safety evaluations of the IP.
D. Before accepting this site, ensure the refrigerator is calibrated and functioning properly.

Answer: A

Explanation:
Since the Wi-Fi connectivity is inconsistent, the CRA must assess the risk and report it to the trial sponsor for a decision. Accepting the site without proper risk evaluation may compromise the monitoring of the investigational product (IP) storage conditions, affecting trial integrity.
The answer follows GCP guidelines that emphasize assessing potential risks during site selection and involving the sponsor when critical issues arise.
"When faced with site-specific issues that may affect data integrity or product safety, the CRA should consult with the sponsor before making a final decision." Objectives:
* Ensuring proper site selection
* Managing potential risks proactively

NEW QUESTION # 93
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