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ACRP Certified Professional Exam Sample Questions (Q21-Q26):

NEW QUESTION # 21
A study subject inadvertently disposed of IP medication bottles. The site should report this to the:

A. IRB/IEC.
B. Medical monitor.
C. Regulatory authority.
D. Sponsor.

Answer: D

Explanation:
The loss or disposal of investigational product (IP) must be reported to the sponsor. The sponsor will evaluate the situation and determine the next steps, including whether additional reporting to regulatory authorities or corrective actions are necessary. Reporting to the sponsor ensures that the accountability of the IP is properly documented and managed.
GCP guidelines specify that any loss or disposal of IP should be immediately reported to the sponsor for appropriate action and documentation.
"Any incident involving the loss, mishandling, or disposal of IP should be reported to the sponsor to maintain accurate drug accountability." Objectives:
* Maintain accurate IP accountability.
* Comply with sponsor requirements for IP management.

NEW QUESTION # 22
What is a systematic and independent examination of trial-related activities and documents todetermine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsors, SOPs, GCP, and the applicable regulatory requirements?

A. Routine monitoring
B. Site qualification
C. Audit
D. Inspection

Answer: C

Explanation:
An audit is a systematic and independent examination of trial-related activities and documents. Its purpose is to determine whether the study was conducted in compliance with the protocol, GCP, and regulatory requirements. Audits are usually performed by the sponsor or an independent auditor and focus on evaluating data integrity and trial conduct.
GCP guidelines define an audit as a thorough examination to ensure adherence to protocol and regulatory requirements.
"An audit is a systematic and independent examination of trial-related activities to verify compliance with the protocol and regulatory standards." Objectives:
Ensure compliance and data integrity.
Identify any gaps in trial conduct.

NEW QUESTION # 23
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 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 null hypothesis that the drug has no effect on cholesterol levels.

Answer: D

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 # 24
A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

A. Source document.
B. Worksheet.
C. CRF.
D. PRO.

Answer: C

Explanation:
A Case Report Form (CRF) is a tool used in clinical trials to collect data as specified by the protocol. It is a printed, optical, or electronic document designed to record all protocol-required information for each trial subject. CRFs are crucial for ensuring that the data collected during the trial is accurate, complete, and consistent with the protocol.
This answer follows GCP guidelines, which describe CRFs as essential documents for capturing and transmitting study data to the sponsor.
"A Case Report Form (CRF) is a printed, optical, or electronic document specifically designed to record all protocol-required information to be reported to the sponsor on each trial subject." Objectives:
* Understand the role of CRFs in clinical trials.
* Ensure accurate and complete data collection.

NEW QUESTION # 25
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. Redact subject identification for privacy protection.
B. Deny the request until the sponsor approves.
C. Consult with the IRB/IEC first.
D. Allow access to the entire records.

Answer: D

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 # 26
......

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