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Fast Download Latest ACRP-CP Dumps Ebook - First-Grade ACRP-CP Exam Tool Guarantee Purchasing Safety

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ACRP Certified Professional Exam Sample Questions (Q58-Q63):

NEW QUESTION # 58
During a mid-study sponsor audit of a clinical trial, the auditor notices that all of the protocol-required subject drug dosing diaries were incomplete. The effect of this will be the inability to:

  • A. Evaluate study data.
  • B. Conduct safety analysis.
  • C. Validate protocol endpoints.
  • D. Verify compliance with IP regimen.

Answer: D

Explanation:
Subject drug dosing diaries are essential for documenting adherence to the investigational product (IP) regimen. Incomplete or missing diaries compromise the ability to verify whether subjects followed the dosing schedule, which directly affects the trial's data integrity and the reliability of efficacy and safety assessments.
GCP guidelines stress the importance of maintaining accurate and complete dosing records to verify subject compliance with the protocol.
"Accurate documentation of dosing is essential to verify compliance with the investigational product regimen and ensure data accuracy." Objectives:
* Maintain accurate IP administration records.
* Ensure compliance monitoring throughout the study.


NEW QUESTION # 59
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 who is independent of the institution/trial site.
  • B. A total of five members.
  • C. One member whose primary area of interest is in the same scientific area.
  • D. One member of the site's QA group.

Answer: A

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 copyright 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 # 60
Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:

  • A. PI
  • B. CRC
  • C. CRA
  • D. Sponsor

Answer: A

Explanation:
The Principal Investigator (PI) is responsible for providing access to study documentation during an audit or inspection. This includes regulatory files, participant records, and study logs. The PI ensures that auditors and inspectors have appropriate access while maintaining the confidentiality of subject data.
GCP guidelines clearly assign the responsibility for maintaining and granting access to trial documentation to the PI at the study site.
"The PI is responsible for ensuring that study-related documents are available for review during audits or inspections." Objectives:
* Maintain transparency during inspections.
* Ensure compliance with documentation requirements.


NEW QUESTION # 61
The process of ensuring and documenting that an electronic data processing system conforms to the sponsor's established requirements for completeness, accuracy, reliability, and consistent intended performance is called:

  • A. Programming
  • B. Validation
  • C. Quality Assurance
  • D. Quality Control

Answer: B

Explanation:
Validation is the process of ensuring that an electronic data processing system meets the sponsor's specifications for completeness, accuracy, reliability, and consistent performance. It involves systematic testing and documentation to demonstrate that the system functions as intended, especially in the context of capturing, processing, and managing clinical trial data.
GCP guidelines specify that validation of electronic systems is crucial to maintain data integrity and compliance with regulatory standards.
"Validation ensures that electronic data systems function according to the sponsor's requirements, maintaining data accuracy and reliability." Objectives:
Maintain data integrity and reliability.
Demonstrate system compliance with regulatory requirements.


NEW QUESTION # 62
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. Dispose of IP and request replacement from sponsor.
  • B. Quarantine IP without registering in IWRS and request replacement from sponsor.
  • C. Register IP in IWRS and continue with subject allocation.
  • D. Register IP in IWRS, quarantine and notify sponsor of the excursion.

Answer: D

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 # 63
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