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

NEW QUESTION # 50
A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

A. No, the PI is taking part in too many ongoing studies to participate in this study.
B. No, the PI does not have the resources to perform all protocol-required procedures.
C. Yes, the PI has a sufficient patient population to take part in this study.
D. Yes, the PI can perform other imaging scans instead of the PET scans.

Answer: B

Explanation:
The PI lacks access to a PET scanner, a required element for conducting the study according to the protocol.
Without this essential equipment, the PI cannot fully meet the study requirements, making it unsuitable for the sponsor to select this site. Compliance with the protocol's technical requirements is crucial for the trial's success.
GCP guidelines state that investigators must have access to all necessary facilities and equipment to conduct the trial as outlined in the protocol.
"The investigator must have adequate resources, including access to required equipment, to perform the study as specified." Objectives:
Ensure site readiness for protocol requirements.
Prevent protocol deviations due to inadequate resources.

NEW QUESTION # 51
Which document confirms the PI's agreement to permit auditing at the study site?

A. Delegation Log
B. ICF
C. Protocol
D. IB

Answer: B

Explanation:
The Informed Consent Form (ICF) typically includes a statement indicating that the participant's records may be reviewed by monitors, auditors, and regulatory authorities. This ensures transparency and compliance with regulatory requirements, allowing for audits and inspections when necessary.
This answer follows GCP guidelines which specify that the ICF should include consent for audits and inspections to protect subject confidentiality while ensuring data integrity.
"The ICF must include a statement allowing access to trial data for monitoring, auditing, and regulatory inspection purposes." Objectives:
* Ensure informed consent for data access.
* Facilitate compliance with auditing requirements.

NEW QUESTION # 52
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 # 53
Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

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

Answer: A

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 # 54
A clinical trial is conducted to measure the effectiveness of music therapy to reduce anxiety in intensive care unit patients. Patients are randomly assigned to receive headphones with music of their choice or headphones with white noise. The group receiving the white noise headphones is considered which type of control group?

A. Placebo
B. No treatment
C. Active control
D. Alternate dose

Answer: A

Explanation:
In this trial, the white noise group acts as a placebo control. While they are receiving an intervention (white noise), it is not the active therapeutic intervention (music therapy) being tested. Placebo controls help in assessing the effect of the active intervention by comparing it to a neutral or non-therapeutic alternative.
GCP guidelines state that a placebo control is a neutral intervention used to compare the effects of an active treatment.
"A placebo group is one that receives a neutral intervention, used to measure the efficacy of the active intervention by comparison." Objectives:
* Differentiate between active and placebo control groups.
* Evaluate therapeutic efficacy objectively.

NEW QUESTION # 55
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Exam ACRP-CP Reviews & ACRP-CP Practice Mock

High-quality ACRP Certified Professional Exam valid exam cram & ACRP ACRP-CP dumps torrent

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

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