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[General] ACRP-CP New Dumps Sheet - Latest Test ACRP-CP Simulations

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【General】 ACRP-CP New Dumps Sheet - Latest Test ACRP-CP Simulations

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ACRP Certified Professional Exam Sample Questions (Q101-Q106):NEW QUESTION # 101
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 null hypothesis that the drug has no effect on cholesterol levels.
  • B. Fail to reject the null hypothesis that the drug has an effect on cholesterol levels.
  • C. Fail to reject the alternative 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: A
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 # 102
Who takes responsibility for initiating a clinical trial?
  • A. Sponsor
  • B. Investigator
  • C. IRB/IEC
  • D. CRO
Answer: A
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 # 103
Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:
  • A. CRA
  • B. PI
  • C. Sponsor
  • D. CRC
Answer: B
Explanation:
The Principal Investigator (PI) is responsible for providing access to study documentation during an audit or inspection. This includes regulatory files, participant records, and study logs. The PI ensures that auditors and inspectors have appropriate access while maintaining the confidentiality of subject data.
GCP guidelines clearly assign the responsibility for maintaining and granting access to trial documentation to the PI at the study site.
"The PI is responsible for ensuring that study-related documents are available for review during audits or inspections." Objectives:
* Maintain transparency during inspections.
* Ensure compliance with documentation requirements.

NEW QUESTION # 104
The process of ensuring and documenting that an electronic data processing system conforms to the sponsor's established requirements for completeness, accuracy, reliability, and consistent intended performance is called:
  • A. Programming
  • B. Quality Control
  • C. Validation
  • D. Quality Assurance
Answer: C
Explanation:
Validation is the process of ensuring that an electronic data processing system meets the sponsor's specifications for completeness, accuracy, reliability, and consistent performance. It involves systematic testing and documentation to demonstrate that the system functions as intended, especially in the context of capturing, processing, and managing clinical trial data.
GCP guidelines specify that validation of electronic systems is crucial to maintain data integrity and compliance with regulatory standards.
"Validation ensures that electronic data systems function according to the sponsor's requirements, maintaining data accuracy and reliability." Objectives:
Maintain data integrity and reliability.
Demonstrate system compliance with regulatory requirements.

NEW QUESTION # 105
Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?
  • A. 2.6 mg/dL
  • B. 3.0 mg/dL
  • C. 1.8 mg/dL
  • D. 3.6 mg/dL
Answer: B
Explanation:
To calculate the maximum allowable creatinine level, multiply the upper limit of normal (1.2 mg/dL) by 2.5.
1.2 x 2.5 = 3.0 mg/dL
Therefore, the maximum creatinine level that a participant can have to remain eligible for the trial is 3.0 mg
/dL.
GCP guidelines specify that eligibility criteria, including lab values, must be strictly followed to maintain protocol compliance.
"The protocol specifies that laboratory values must not exceed the defined limits to ensure participant safety and data integrity." Objectives:
* Maintain accurate interpretation of laboratory criteria.
* Ensure compliance with protocol-defined inclusion/exclusion criteria.

NEW QUESTION # 106
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