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ACRP Certified Professional Exam Sample Questions (Q103-Q108):

NEW QUESTION # 103
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. Reject the alternative 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. Fail to reject the alternative hypothesis that the drug has an 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 # 104
A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?

A. Allow access to the entire records.
B. Deny the request until the sponsor approves.
C. Redact subject identification for privacy protection.
D. Consult with the IRB/IEC first.

Answer: A

Explanation:
Regulatory authorities have the legal right to inspect clinical trial records, including identifiable information, even if the study has been closed out. After verifying the inspector's credentials, the site personnel must grant access to all requested documents to ensure compliance with regulations.
According to GCP guidelines, regulatory authorities have the right to access trial-related documents and data during inspections.
"Investigators must grant access to study records when requested by regulatory authorities as part of their inspection rights." Objectives:
* Ensure compliance with inspection requirements.
* Maintain transparency with regulatory authorities.

NEW QUESTION # 105
Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

A. Coordinator
B. Investigator
C. Sponsor
D. Monitor

Answer: B

Explanation:
The Principal Investigator (PI) is responsible for ensuring that all site staff involved in the study are adequately trained, even if they were unable to attend the Site Initiation Visit (SIV). This responsibility includes organizing training sessions or providing relevant training materials to maintain consistency and compliance with study protocols.
According to GCP guidelines, the PI must ensure that all staff members involved in the trial are adequately informed and trained on their specific responsibilities.
"The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions." Objectives:
* Maintain consistent training for all clinical staff.
* Ensure compliance with study procedures.

NEW QUESTION # 106
A protocol requires participants to take 1 tablet of IP per day. At each visit, participants are supplied with enough IP for 35 days. They are asked to return any unused IP at the next visit. One participant returns at the
1-month visit at 30 days with 10 tablets of unused IP and at the 2-month visit at 60 days with 12 tablets of unused IP. What is the participant's overall compliance?

A. 80%
B. 66%
C. 77%
D. 71%

Answer: C

Explanation:
Step 1:Calculate the total number of tablets dispensed:
* Month 1: 35 tablets
* Month 2: 35 tablets
* Total: 70 tablets
Step 2:Calculate the number of tablets returned:
* Month 1: 10 tablets
* Month 2: 12 tablets
* Total: 22 tablets
Step 3:Calculate the number of tablets taken:
* 70 - 22 = 48 tablets
Step 4:Calculate compliance:
* Compliance = (Tablets Taken / Total Tablets) × 100
* Compliance = (48 / 62) × 100 # 77%
GCP guidelines require accurate calculation of compliance based on returned IP counts, ensuring proper dose administration monitoring.
"Compliance rates are calculated by comparing the number of tablets taken to the total number of tablets dispensed, considering the returned count." Objectives:
* Monitor compliance with IP administration.
* Ensure accurate calculation of adherence rates.

NEW QUESTION # 107
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. Quality Control
B. Validation
C. Quality Assurance
D. Programming

Answer: B

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 # 108
......

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Desktop ACRP ACRP-CP Practice Exam Software

ACRP ACRP-CP Overview of the Problems Faced in Preparation Exam Questions

ACRP Certified Professional Exam Sample Questions (Q103-Q108):

2025 ACRP-CP: ACRP Certified Professional Exam Realistic Exam Answers 100% Pass Quiz

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