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ACRP-CP Related Exams | ACRP-CP Test Pdf

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ACRP Certified Professional Exam Sample Questions (Q65-Q70):

NEW QUESTION # 65
AEs that occur between study visits of a clinical trial should be evaluated by the:

A. Principal Investigator
B. Subject's primary care physician
C. Medical monitor
D. Study pharmacovigilance physician

Answer: A

Explanation:
The Principal Investigator (PI) is responsible for evaluating Adverse Events (AEs) that occur between study visits. The PI must assess the severity, causality, and potential relationship to the investigational product (IP).
Proper evaluation ensures that any necessary medical interventions are promptly administered and that relevant information is recorded and reported accurately.
GCP guidelines specify that the PI is accountable for the medical care of trial subjects, including evaluating AEs and ensuring their safety.
"The PI must evaluate any adverse events occurring between study visits to determine their relevance to the investigational product and manage patient care." Objectives:
* Ensure prompt and accurate evaluation of AEs.
* Maintain the safety and well-being of study participants.

NEW QUESTION # 66
Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

A. Monitor
B. Coordinator
C. Investigator
D. Sponsor

Answer: C

Explanation:
The Principal Investigator (PI) is responsible for ensuring that all site staff involved in the study are adequately trained, even if they were unable to attend the Site Initiation Visit (SIV). This responsibility includes organizing training sessions or providing relevant training materials to maintain consistency and compliance with study protocols.
According to GCP guidelines, the PI must ensure that all staff members involved in the trial are adequately informed and trained on their specific responsibilities.
"The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions." Objectives:
* Maintain consistent training for all clinical staff.
* Ensure compliance with study procedures.

NEW QUESTION # 67
Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

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

Answer: B

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 # 68
In a quality management system, in which category do risk reduction activities belong?

A. Risk Control
B. Risk Review
C. Risk Communication
D. Risk Evaluation

Answer: A

Explanation:
Risk reduction activities fall underRisk Controlwithin a Quality Management System (QMS). Risk control involves implementing measures to reduce identified risks to an acceptable level, including corrective actions, preventive measures, and continuous monitoring. It aims to mitigate potential negative impacts on trial integrity and participant safety.
GCP guidelines highlight that risk control encompasses actions taken to minimize the likelihood and impact of identified risks.
"Risk control is the process of implementing measures to mitigate risks identified during the risk assessment phase." Objectives:
* Implement effective risk management strategies.
* Ensure proactive risk mitigation in clinical trials.

NEW QUESTION # 69
A clinical trial is conducted to test the effect of an investigational drug on cholesterol levels. Statistical analysis will be performed to:

A. Fail to reject the alternative hypothesis that the drug has an effect on cholesterol levels.
B. Reject the null hypothesis that the drug has no effect on cholesterol levels.
C. Reject the alternative hypothesis that the drug has no effect on cholesterol levels.
D. Fail to reject the null hypothesis that the drug has an effect on cholesterol levels.

Answer: B

Explanation:
The purpose of statistical analysis in a clinical trial is to evaluate whether the data supports rejecting the null hypothesis, which typically states that there is no effect or difference. If the analysis finds a statistically significant result, the null hypothesis is rejected, indicating that the investigational drug has an effect on cholesterol levels.
The answer follows statistical principles in clinical trials, where the null hypothesis is rejected if evidence shows a significant difference or effect.
"In hypothesis testing, rejecting the null hypothesis indicates that the treatment effect is statistically significant." Objectives:
* Understand hypothesis testing in clinical research.
* Interpret statistical outcomes accurately.

NEW QUESTION # 70
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