THE BEST ACCURATE ACRP-CP ONLINE TESTS - EASY AND GUARANTEED ACRP-CP EXAM SUCCESS

The Best Accurate ACRP-CP Online Tests - Easy and Guaranteed ACRP-CP Exam Success

The Best Accurate ACRP-CP Online Tests - Easy and Guaranteed ACRP-CP Exam Success

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ACRP Certified Professional Exam Sample Questions (Q80-Q85):

NEW QUESTION # 80
Who should vote during the IRB/IEC review and discussion process?

  • A. All members who were involved in the review and discussion
  • B. All members who were involved in the review and discussion and non-member experts
  • C. All IRB/IEC members
  • D. All IRB/IEC members and non-member experts

Answer: A

Explanation:
During the IRB/IEC review process, only members who actively participated in the review and discussion are eligible to vote. This ensures that votes are cast by those who are adequately informed about the study and can make an educated decision. Non-member experts may participate in discussions but do not have voting rights.
GCP guidelines state that voting rights in IRB/IEC meetings are limited to members who have thoroughly reviewed and discussed the study, maintaining unbiased and informed decision-making.
"Only IRB/IEC members who were involved in the review and discussion should participate in the voting process." Objectives:
* Ensure informed voting in ethical review processes.
* Maintain integrity and objectivity in IRB/IEC decisions.


NEW QUESTION # 81
Which of the following should be considered when implementing a risk-based monitoring plan?

  • A. Monitoring schedule must be pre-defined in the monitoring plan.
  • B. Centralized monitoring must be incorporated in any trials.
  • C. On-site monitoring frequency may change depending on the quality of the data.
  • D. 100% source document review is mandatory.

Answer: C

Explanation:
Risk-based monitoring focuses on adapting the frequency and intensity of on-site visits based on data quality and site performance. If the data is consistently accurate and reliable, the monitoring frequency may be reduced. Conversely, if issues are identified, more frequent monitoring may be necessary.
GCP guidelines emphasize a flexible approach to monitoring, allowing adjustments based on the risk profile and quality of data collected.
"Risk-based monitoring involves adapting the frequency of on-site visits according to the quality of the data and the site's compliance level." Objectives:
* Implement a dynamic monitoring strategy.
* Enhance efficiency while maintaining data integrity.


NEW QUESTION # 82
A study protocol must contain which of the following elements?

  • A. Participant reimbursement details
  • B. Chemical structure of the IP
  • C. Data management plan
  • D. Description of statistical methods

Answer: D

Explanation:
A clinical study protocol must include a clear description of the statistical methods to be used in analyzing the collected data. This ensures that the analysis plan is predefined, unbiased, and statistically sound. The statistical methodology must address how the primary and secondary endpoints will be evaluated.
GCP guidelines require that the protocol clearly outlines statistical methods to ensure accurate and unbiased analysis of trial data.
"The protocol should include a detailed description of the statistical methods employed to ensure the validity of the trial results." Objectives:
* Maintain transparency in data analysis.
* Ensure scientific rigor in evaluating study outcomes.


NEW QUESTION # 83
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. Fail to reject the null hypothesis that the drug has an effect on cholesterol levels.
  • D. Reject the alternative hypothesis that the drug has no 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 # 84
Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

  • A. Training records of site personnel on study protocol, and their study-related duties and functions.
  • B. Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
  • C. A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
  • D. A monitoring report that identifies deviation from the approved protocol.

Answer: A

Explanation:
The PI is responsible for maintaining training records of site personnel, which demonstrate compliance with the sponsor's requirements for conducting the trial. Proper documentation of training ensures that all team members are knowledgeable about the protocol and study procedures.
GCP guidelines mandate that the PI maintains adequate records to demonstrate that all personnel involved in the study are properly trained and qualified.
"Training records of site personnel must be maintained to verify that the team is adequately trained on the protocol and their specific responsibilities." Objectives:
* Maintain training compliance.
* Document personnel qualifications for quality assurance.


NEW QUESTION # 85
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