VALID TRAINING ACRP-CP KIT FOR PASSING ACRP-CP EXAM PREPARATION

Valid Training ACRP-CP Kit for Passing ACRP-CP Exam Preparation

Valid Training ACRP-CP Kit for Passing ACRP-CP Exam Preparation

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Tags: Training ACRP-CP Kit, Trustworthy ACRP-CP Exam Content, Valid Test ACRP-CP Braindumps, ACRP-CP Pdf Dumps, Trusted ACRP-CP Exam Resource

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ACRP Certified Professional Exam Sample Questions (Q26-Q31):

NEW QUESTION # 26
A deferred consent can take place in which of the following situations?

  • A. Only when the PI approves such a consent process immediately prior to patient enrollment, regardless of the situation being classed as emergency.
  • B. Only when the PI approves such a consent process, regardless of the emergency situation described in the protocol.
  • C. In an emergency situation only, even when this process is not described in the protocol, but the sponsor approves the consent process.
  • D. In an emergency situation only, when this process is described in the protocol and has received permission from the ethics committee.

Answer: D

Explanation:
Deferred consent is permissible in emergency situations where immediate intervention is necessary and obtaining prior consent is not feasible. However, this practice must be explicitly described in the protocol and approved by the ethics committee. This ensures that the rights of patients are protected even in urgent circumstances.
GCP guidelines emphasize that deferred consent is only allowed when pre-approved by the ethics committee as part of the protocol for emergency interventions.
"In emergencies, deferred consent is permitted only if outlined in the protocol and approved by the ethics committee, ensuring compliance with ethical standards." Objectives:
* Protect patient rights in emergency research.
* Ensure ethical approval for deferred consent.


NEW QUESTION # 27
Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

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

Answer: D

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 # 28
Centralized monitoring can:

  • A. Indicate the need to send monitors to perform onsite visits.
  • B. Confirm why sites are deviating from the protocol.
  • C. Identify IP accountability and storage issues.
  • D. Enable appropriate stratification of subject enrollment.

Answer: A

Explanation:
Centralized monitoring involves the remote evaluation of data trends, outliers, and inconsistencies across sites. If significant issues are identified through centralized monitoring, it may prompt the need for targeted on-site visits to investigate and resolve the identified issues. This approach optimizes resource utilization and focuses on potential problem areas.
GCP guidelines support the use of centralized monitoring to identify risks that warrant on-site monitoring, promoting efficient and targeted oversight.
"Centralized monitoring can identify data patterns or anomalies that indicate the need for an on-site visit to verify and address the issue." Objectives:
* Enhance monitoring efficiency through data-driven decisions.
* Prioritize on-site visits based on identified risks.


NEW QUESTION # 29
A study subject inadvertently disposed of IP medication bottles. The site should report this to the:

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

Answer: B

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 # 30
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. 3.0 mg/dL
  • B. 3.6 mg/dL
  • C. 2.6 mg/dL
  • D. 1.8 mg/dL

Answer: A

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 # 31
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