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ACRP Certified Professional Exam Sample Questions (Q11-Q16):

NEW QUESTION # 11
IP is dispensed to all subjects who:

A. Consented for the trial.
B. Need IP for their medical condition.
C. Screened for the trial.
D. Are eligible to receive it in the trial.

Answer: D

Explanation:
The investigational product (IP) is only dispensed to subjects who meet the eligibility criteria as defined in the study protocol. Eligibility is confirmed during screening and baseline assessments. Simply consenting to the trial does not guarantee receipt of IP.
According to GCP guidelines, IP dispensing must strictly follow eligibility criteria to maintain protocol compliance and subject safety.
"IP should only be dispensed to subjects who have been deemed eligible according to the protocol's inclusion and exclusion criteria." Objectives:
* Maintain adherence to protocol criteria.
* Protect participant safety by ensuring proper eligibility.

NEW QUESTION # 12
A study sponsor approaches a facility about participating in their research study. The study sponsor requires use of social media as its sole method of recruitment. The site knows their institutional IRB/IEC does not approve of social media recruiting. How should the site respond?

A. Decline the study.
B. Use a central IRB/IEC.
C. Rely on the sponsor to notify the IRB/IEC.
D. Recruit for the study without use of social media.

Answer: A

Explanation:
If the IRB/IEC has a policy that does not permit social media recruiting, the site must adhere to these regulations. Proceeding with a method not approved by the IRB/IEC would violate compliance requirements, so declining the study is the correct course of action.
The answer aligns with IRB/IEC regulations that prioritize ethical and compliant recruitment methods.
"Sites must follow the recruitment methods approved by their IRB/IEC to maintain compliance and ethical standards." Objectives:
* Adhering to ethical recruitment practices.
* Maintaining compliance with IRB/IEC policies.

NEW QUESTION # 13
A study protocol must contain which of the following elements?

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

Answer: C

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 # 14
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. Consult with the IRB/IEC first.
B. Allow access to the entire records.
C. Deny the request until the sponsor approves.
D. Redact subject identification for privacy protection.

Answer: B

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 # 15
Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

A. Protocol, site coordinator CVs, and clinical trial agreement
B. Protocol, IB, and information about payments and compensation available to subjects
C. Protocol, informed consent, and clinical trial agreement
D. IB, site coordinator CVs, and information about payments and compensation available to subjects

Answer: B

Explanation:
Before a clinical trial can begin, the IRB/IEC must review the protocol, Investigator's Brochure (IB), and any information related to payments and compensation. This review ensures that the study is ethically sound, scientifically valid, and that participants are informed about any financial considerations.
GCP guidelines specify that essential documents, including the protocol, IB, and compensation details, must be reviewed by the IRB/IEC to maintain ethical oversight.
"The IRB/IEC must evaluate the protocol, IB, and any financial disclosures to ensure ethical compliance and participant protection." Objectives:
* Guarantee ethical oversight in clinical trial conduct.
* Protect participants through informed consent and transparency.

NEW QUESTION # 16
......

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ACRP-CP Reliable Study Materials, Latest ACRP-CP Exam Questions Vce

ACRP-CP Reliable Study Materials Exam Pass Once Try | ACRP-CP: ACRP Certified Professional Exam

ACRP Certified Professional Exam Sample Questions (Q11-Q16):

Exam Questions for ACRP ACRP-CP in PDF Format

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