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ACRP Certified Professional Exam Sample Questions (Q50-Q55):

NEW QUESTION # 50
Which of the following reports should be retained in participant charts?

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

Answer: A

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 # 51
Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

A. Perform a periodic review to see if the quality methods are effective and relevant.
B. Determine the quality tolerance limits for data transcription errors.
C. Identify critical processes and data during protocol development.
D. Train the research coordinator on the required study assessments schedule.

Answer: C

Explanation:
The first step in establishing a robust quality management system (QMS) is to identify critical processes and data during protocol development. This step ensures that quality objectives are clear and that monitoring and quality control efforts are focused on the most significant aspects of the study. By understanding critical data points and processes early, the sponsor can design a more effective QMS to manage risks.
GCP guidelines emphasize identifying critical data and processes at the earliest stages to develop a risk-based quality management approach.
"Identification of critical data and processes at the protocol development stage is essential for designing an effective quality management system." Objectives:
* Establish quality oversight from the start.
* Implement a risk-based monitoring approach.

NEW QUESTION # 52
Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:

A. Applicable regulatory authorities
B. Sponsor
C. PI
D. Applicable site SOPs

Answer: A

Explanation:
The confidentiality and privacy rules protecting human subjects in clinical research are established by applicable regulatory authorities, such as the FDA or EMA, and must be followed by all research sites. These regulations ensure that participants' personal data are handled securely and ethically.
GCP guidelines mandate compliance with local, national, and international regulations regarding data confidentiality and privacy.
"Confidentiality and privacy protections are determined by applicable regulatory authorities and must be adhered to by all study sites." Objectives:
* Protect participant privacy.
* Ensure compliance with data protection regulations.

NEW QUESTION # 53
Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?

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

Answer: D

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 # 54
The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

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

Answer: A

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 # 55
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Isaac Clark Isaac Clark

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