HIGH PASS RATE ACRP CERTIFIED PROFESSIONAL EXAM TEST TORRENT IS CONVENIENT TO DOWNLOAD - EXAMSREVIEWS

High Pass Rate ACRP Certified Professional Exam Test Torrent is Convenient to Download - ExamsReviews

High Pass Rate ACRP Certified Professional Exam Test Torrent is Convenient to Download - ExamsReviews

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ACRP Certified Professional Exam Sample Questions (Q48-Q53):

NEW QUESTION # 48
Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?

  • A. Conduct annual reviews of the protocol and accompanying study documents.
  • B. Ensure there is an accompanying written record that describes the consent process.
  • C. Develop a plan that describes the monitoring approach for a clinical study.
  • D. Ensure submission of a data management plan to the regulatory authorities.

Answer: C

Explanation:
Developing a monitoring plan that outlines the approach to quality assurance is essential for maintaining data integrity throughout the clinical trial. This plan helps identify critical data points, risk-based monitoring strategies, and procedures for detecting and correcting data discrepancies. It ensures that the study data collected is accurate, complete, and verifiable.
GCP guidelines emphasize the importance of a monitoring plan to safeguard the quality and integrity of study data.
"The sponsor should develop a comprehensive monitoring plan to ensure the accuracy, completeness, and consistency of trial data." Objectives:
* Maintain high-quality data through structured monitoring.
* Identify potential risks and address them proactively.


NEW QUESTION # 49
The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

  • A. Regulatory Agency
  • B. PI
  • C. CRC
  • D. Sponsor

Answer: B

Explanation:
When the IRB/IEC decides not to approve a clinical trial, they must notify the Principal Investigator (PI) in writing. This communication ensures that the PI is formally informed of the decision and cantake appropriate actions, such as revising the protocol or addressing the reasons for disapproval.
According to GCP guidelines, the IRB/IEC must communicate any decision regarding the approval status of a study directly to the PI, as the PI is responsible for the conduct of the trial.
"The IRB/IEC should promptly notify the investigator in writing of its decision to approve or disapprove the proposed research activity." Objectives:
* Maintain clear communication between the IRB/IEC and the investigator.
* Ensure timely notification of decisions affecting the study.


NEW QUESTION # 50
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. Quality Control
  • B. Quality Assurance
  • C. Validation
  • D. Programming

Answer: C

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 # 51
A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?

  • A. Factorial
  • B. Group sequential
  • C. Crossover
  • D. Parallel Group

Answer: C

Explanation:
A crossover study design involves participants receiving multiple interventions sequentially, with a washout period in between to minimize carryover effects. This design allows each participant to serve as their own control, increasing statistical power while reducing variability. It is commonly used when comparing two treatments or interventions.
GCP guidelines classify a crossover design as one where subjects receive multiple treatments in a specified sequence.
"In crossover trials, participants receive each intervention in a specific order, allowing for within-subject comparison." Objectives:
* Understand the structure of crossover studies.
* Improve statistical efficiency through self-control comparisons.


NEW QUESTION # 52
Which statement does NOT represent a study monitor's responsibilities?

  • A. Verify that the PI has adequate qualifications and resources to conduct the study.
  • B. Report serious adverse events to the IRB/IEC.
  • C. Provide communication between the sponsor and the PI.
  • D. Check the accuracy and completeness of case report forms with source documents.

Answer: B

Explanation:
It is not the monitor's responsibility to report serious adverse events (SAEs) to the IRB/IEC. This responsibility typically falls on the PI or the sponsor. Monitors focus on data accuracy, protocol compliance, and communication between the site and the sponsor.
The answer follows GCP standards where the monitor's role is clearly defined, excluding SAE reporting to IRB/IEC.
"Monitors are responsible for verifying data accuracy and communicating with the sponsor but not for direct reporting of SAEs to the IRB/IEC." Objectives:
* Distinguish between the responsibilities of monitors and investigators
* Clarify SAE reporting protocols


NEW QUESTION # 53
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