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ACRP-CP Exam Objectives Pdf, ACRP-CP Valid Exam Pattern

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ACRP-CP Valid Exam Pattern, Exam ACRP-CP Quizzes

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ACRP Certified Professional Exam Sample Questions (Q78-Q83):

NEW QUESTION # 78
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. Alternate dose
B. Placebo
C. No treatment
D. Active control

Answer: B

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 # 79
Centralized monitoring can:

A. Indicate the need to send monitors to perform onsite visits.
B. Identify IP accountability and storage issues.
C. Confirm why sites are deviating from the protocol.
D. Enable appropriate stratification of subject enrollment.

Answer: A

Explanation:
Centralized monitoring involves the remote evaluation of data trends, outliers, and inconsistencies across sites. If significant issues are identified through centralized monitoring, it may prompt the need for targeted on-site visits to investigate and resolve the identified issues. This approach optimizes resource utilization and focuses on potential problem areas.
GCP guidelines support the use of centralized monitoring to identify risks that warrant on-site monitoring, promoting efficient and targeted oversight.
"Centralized monitoring can identify data patterns or anomalies that indicate the need for an on-site visit to verify and address the issue." Objectives:
* Enhance monitoring efficiency through data-driven decisions.
* Prioritize on-site visits based on identified risks.

NEW QUESTION # 80
A PI on a study is a regular member of the IRB/IEC. Which of the following statements is TRUE regarding their participation in the IRB/IEC discussion and deliberation?

A. They can attend the meeting, but should not vote/provide opinion on whether to approve the study.
B. They must recuse themselves from the meeting given their dual roles as IRB/IEC member and PI.
C. They can attend the meeting and can vote/provide opinion on whether to approve the study.
D. They cannot be the PI on the clinical study due to conflict of interest.

Answer: B

Explanation:
If a PI is also a member of the IRB/IEC, they must recuse themselves from the meeting when their own study is being reviewed to avoid conflicts of interest. This practice preserves the objectivity and impartiality of the IRB/IEC's decisions.
The answer is verified based on IRB/IEC operational guidelines, which mandate that members with potential conflicts recuse themselves from discussions and voting.
"To maintain objectivity, IRB/IEC members who have a conflict of interest related to a study must recuse themselves from the review and decision-making process." Objectives:
* Maintain impartiality in IRB/IEC decisions
* Prevent conflicts of interest in clinical trial approval

NEW QUESTION # 81
Who takes responsibility for initiating a clinical trial?

A. Investigator
B. CRO
C. Sponsor
D. IRB/IEC

Answer: C

Explanation:
The sponsor is responsible for initiating a clinical trial. This involves developing the protocol, securing funding, selecting study sites, and obtaining regulatory approvals. The sponsor also oversees the conduct of the trial to ensure compliance with GCP and regulatory requirements.
According to GCP guidelines, the sponsor is the entity that initiates, manages, and finances the clinical investigation.
"The sponsor is responsible for initiating, managing, and financing the clinical trial, including protocol development and site selection." Objectives:
* Understand the sponsor's role in trial initiation.
* Ensure compliance from the outset of the study.

NEW QUESTION # 82
Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

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

Answer: D

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 # 83
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