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ACRP Certified Professional Exam Sample Questions (Q37-Q42):

NEW QUESTION # 37
A clinical trial is conducted to test the effect of an investigational drug on cholesterol levels. Statistical analysis will be performed to:

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

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 # 38
Who on the local site research study team is accountable for the unblinding documentation of IP?

A. PI
B. CRC
C. Pharmacist
D. Regulatory manager

Answer: A

Explanation:
The Principal Investigator (PI) is ultimately responsible for maintaining and documenting any unblinding events related to the investigational product (IP). This accountability ensures that any instance where the blind is broken is properly justified, documented, and reported to maintain trial integrity.
GCP guidelines state that the PI must oversee the unblinding process and ensure proper documentation to protect the validity of the trial data.
"The PI is responsible for ensuring that any unblinding of the investigational product is adequately documented and reported according to protocol." Objectives:
* Maintain the integrity of blinded studies.
* Properly document unblinding incidents.

NEW QUESTION # 39
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 must recuse themselves from the meeting given their dual roles as IRB/IEC member and PI.
B. They can attend the meeting and can vote/provide opinion on whether to approve the study.
C. They can attend the meeting, but should not 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: A

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 # 40
Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?

A. The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.
B. The regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.
C. The CRC is responsible for identifying the relationship of an SAE to the IP.
D. The sponsor is responsible for overseeing any delegated activities to a CRO and ensuring that the delegation of these activities is documented.

Answer: D

Explanation:
The sponsor holds the responsibility for overseeing any activities delegated to a Contract Research Organization (CRO). This includes ensuring that all delegated tasks are clearly documented and that the CRO performs them according to regulatory standards and the study protocol.
GCP guidelines state that while the sponsor may delegate tasks to a CRO, the ultimate responsibility for the trial's conduct remains with the sponsor.
"The sponsor retains responsibility for overseeing any delegated tasks to the CRO and must ensure that these responsibilities are appropriately documented." Objectives:
* Clarify delegation of duties in clinical trials.
* Maintain sponsor oversight for regulatory compliance.

NEW QUESTION # 41
Who must be blinded in a double-blind study in order to prevent bias?

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

Answer: B

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 # 42
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