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ACRP Certified Professional Exam Sample Questions (Q16-Q21):

NEW QUESTION # 16
Who must be blinded in a double-blind study in order to prevent bias?

A. IRB/IEC
B. Pharmacist
C. Data entry staff
D. Subject

Answer: D

Explanation:
In a double-blind study, both the participant (subject) and the investigator (or clinical staff administering the treatment) are blinded. This approach minimizes bias in treatment administration and outcome assessment.
Blinding the subject ensures that their responses are not influenced by their knowledge of the treatment they are receiving.
According to GCP guidelines, double-blinding is essential to eliminate both participant and investigator bias, ensuring objective trial results.
"Double-blind studies ensure that neither the participant nor the investigator knows which intervention is being administered, thereby minimizing bias." Objectives:
* Maintain the integrity of the study by preventing bias.
* Enhance the validity of trial outcomes.

NEW QUESTION # 17
When assessing the monitoring needs for a study, sponsors should:

A. Use central monitoring instead of conducting physical monitoring visits at sites.
B. Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
C. Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.
D. Permit PIs to select a monitor for their site as long as they are independent of the PI.

Answer: C

Explanation:
Sponsors must ensure that monitors are adequately qualified, possessing the necessary scientific and clinical knowledge to effectively oversee the trial. This ensures that monitors can accurately assess protocol compliance, data integrity, and participant safety. The quality of monitoring directly impacts the credibility of the trial outcomes.
GCP guidelines specify that monitors must be adequately trained and knowledgeable about the trial protocol, investigational product (IP), and clinical research standards.
"The sponsor must ensure that monitors have appropriate qualifications and training to conduct effective trial monitoring." Objectives:
* Maintain data integrity through skilled monitoring.
* Ensure patient safety and protocol compliance.

NEW QUESTION # 18
A sponsor writes a protocol comparing an IP XYZ to a marketed drug ABC to determine if XYZ is more efficacious in the target population than ABC. Both drugs are prepared in identically masked IV bags and distributed according to the randomization scheme outlined in the protocol such that the study team is unaware of the treatment assignment.
Which of the following is an appropriate title for this study?

A. A randomized, double-blind, double-dummy, superiority study comparing the efficacy of XYZ to ABC in the target population
B. A randomized, open-label, comparator study comparing the efficacy of XYZ to ABC in the target population
C. A randomized, double-blind, superiority study comparing the efficacy of XYZ to ABC in the target population
D. A randomized, single-blind, placebo-controlled study comparing the efficacy of XYZ to ABC in the target population

Answer: C

Explanation:
Since both the investigator and the participant are unaware of the treatment assignment, the study is classified as double-blind. The study aims to establish the superiority of XYZ over ABC, making it a superiority study.
The use of masked IV bags confirms the double-blind design.
The answer is verified from GCP guidelines on blinding and superiority study designs.
"In double-blind studies, neither the participant nor the investigator knows the treatment assignment, which prevents bias." Objectives:
* Understanding blinding methods in clinical trials
* Ensuring unbiased efficacy comparisons

NEW QUESTION # 19
The coding system for a double-blind clinical trial is accessible by the:

A. IRB/IEC
B. Sponsor
C. Regulatory authority
D. PI

Answer: B

Explanation:
The sponsor is typically responsible for maintaining the code that links the treatment assignment to participants in a double-blind clinical trial. The code is securely maintained and is only accessible in cases where unblinding is necessary for safety reasons. This process helps to preserve the integrity of the study while allowing for emergency unblinding if needed.
GCP guidelines state that the sponsor should maintain the blind unless unblinding is necessary due to safety concerns or regulatory requirements.
"The sponsor maintains the randomization code and ensures that unblinding occurs only when necessary, to protect the study's integrity." Objectives:
* Maintain the integrity of double-blind trials.
* Allow controlled access to randomization codes.

NEW QUESTION # 20
Who determines the age of assent for pediatric studies?

A. IRB/IEC
B. PI
C. Parent
D. Sponsor

Answer: A

Explanation:
The IRB/IEC determines the age at which a child is considered capable of providing assent for participation in a clinical trial. This decision is based on local regulations, cultural considerations, and the child's ability to understand the trial's risks and benefits. The age of assent may vary between jurisdictions and is subject to ethical considerations specific to pediatric research.
GCP guidelines emphasize that the IRB/IEC is responsible for setting the criteria for obtaining assent from minors based on ethical and regulatory frameworks.
"The IRB/IEC is responsible for determining the age and circumstances under which pediatric assent is required, considering the child's comprehension level." Objectives:
* Ensure appropriate ethical practices in pediatric research.
* Align with local regulatory requirements for assent.

NEW QUESTION # 21
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100% Pass Quiz 2025 ACRP Fantastic ACRP-CP: ACRP Certified Professional Exam New Braindumps

2025 ACRP Perfect ACRP-CP New Braindumps

ACRP Certified Professional Exam Sample Questions (Q16-Q21):

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