QUIZ 2025 ACRP-CP: ACRP CERTIFIED PROFESSIONAL EXAM–TRUSTABLE TEST FREE

Quiz 2025 ACRP-CP: ACRP Certified Professional Exam–Trustable Test Free

Quiz 2025 ACRP-CP: ACRP Certified Professional Exam–Trustable Test Free

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ACRP Certified Professional Exam Sample Questions (Q52-Q57):

NEW QUESTION # 52
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. Inspection
  • B. Site qualification
  • C. Routine monitoring
  • D. Audit

Answer: D

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 # 53
Who ensures information regarding payments to subjects is documented in a written consent form?

  • A. IRB/IEC
  • B. Sponsor
  • C. PI
  • D. Coordinator

Answer: A

Explanation:
The IRB/IEC is responsible for reviewing and approving the consent form, which must include any information about payments to participants. This ensures transparency and ethical compliance regarding compensation.
The answer is verified according to GCP guidelines, which mandate IRB/IEC review of consentforms, including payment details.
"IRB/IEC must ensure that the informed consent process is thorough and includes disclosure of any compensation or payment to participants." Objectives:
* Guaranteeing informed consent quality
* Ensuring transparency about participant payments


NEW QUESTION # 54
All site financial matters pertaining to a trial are listed in what document?

  • A. Signed contract
  • B. Protocol
  • C. Financial disclosure
  • D. Informed consent form

Answer: A

Explanation:
All financial agreements, including compensation, budgeting, and payment terms related to the conduct of a clinical trial, are documented in the signed contract between the sponsor and the site. This contract outlines the financial responsibilities and ensures transparency and compliance.
GCP guidelines stipulate that financial matters related to the conduct of a trial are to be formally documented in contractual agreements.
"The financial aspects of a clinical trial must be outlined in the signed agreement between the sponsor and the site, ensuring clear understanding of compensation and obligations." Objectives:
* Ensure financial transparency and accountability.
* Maintain compliance with contractual obligations.


NEW QUESTION # 55
A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

  • A. Data Manager
  • B. Sponsor
  • C. Monitor
  • D. QA Department

Answer: C

Explanation:
After data entry into the Electronic Data Capture (EDC) system, the monitor (typically a Clinical Research Associate - CRA) conducts Source Data Verification (SDV). The monitor compares the data entered in the EDC system with the source documents to ensure accuracy, completeness, and consistency. This step is essential for maintaining data integrity and compliance with GCP standards.
GCP guidelines require that monitors verify data accuracy through SDV as part of routine monitoring responsibilities.
"The monitor is responsible for performing Source Data Verification (SDV) to ensure that the data recorded in the EDC system matches the source documents." Objectives:
* Verify data accuracy in clinical trials.
* Ensure compliance with data management protocols.


NEW QUESTION # 56
All of the following are examples of what monitors review EXCEPT:

  • A. Documentation in the participant's medical record of study drug administration.
  • B. The signed ICF retained in the participant's study file.
  • C. Potential patient medical records for eligibility prior to the informed consent process.
  • D. Regulatory binder which includes copies of current certifications for all laboratories.

Answer: C

Explanation:
Monitors are responsible for reviewing documents that pertain to study conduct and data integrity,including regulatory binders, informed consent forms (ICFs), and documentation of study drug administration.
However, reviewing potential patient medical records for eligibility prior to the informed consent process is not part of a monitor's responsibilities, as this would violate patient confidentiality and GCP standards.
According to GCP guidelines, monitors should ensure compliance with the protocol and data integrity but should not access non-consented patient records.
"Monitors should verify that only enrolled and consented subjects' data are reviewed, ensuring compliance with privacy regulations." Objectives:
* Understand the scope of monitoring responsibilities.
* Protect patient confidentiality during the monitoring process.


NEW QUESTION # 57
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