LATEST ACRP ACRP-CP TEST QUESTIONS | NEW ACRP-CP EXAM GUIDE

Latest ACRP ACRP-CP Test Questions | New ACRP-CP Exam Guide

Latest ACRP ACRP-CP Test Questions | New ACRP-CP Exam Guide

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Tags: Latest ACRP-CP Test Questions, New ACRP-CP Exam Guide, ACRP-CP Download Pdf, Guaranteed ACRP-CP Success, ACRP-CP Test Papers

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ACRP Certified Professional Exam Sample Questions (Q31-Q36):

NEW QUESTION # 31
A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?

  • A. Withdraw the subject.
  • B. Notify the sponsor.
  • C. Notify the regulatory authority.
  • D. Notify the subject.

Answer: B

Explanation:
When a protocol deviation is identified, especially one involving inclusion criteria, the sponsor must be notified immediately. The sponsor will assess the deviation and determine whether the subject can continue in the study. Early notification ensures appropriate action and compliance with protocol and regulatory guidelines.
This answer aligns with GCP principles that mandate sponsor notification in case of protocol deviations, especially when they may impact participant safety or data integrity.
"Any deviation from the protocol that affects subject eligibility must be reported to the sponsor immediately for evaluation and guidance." Objectives:
* Maintain adherence to protocol inclusion criteria.
* Report deviations promptly for safety assessment.


NEW QUESTION # 32
A root cause analysis should be:

  • A. Specific to a clinical trial.
  • B. Written by the investigator.
  • C. Validated before use in a CAPA.
  • D. Focused on issues of non-compliance.

Answer: D

Explanation:
Root cause analysis (RCA) is a systematic process aimed at identifying the underlying reasons for non- compliance or errors in clinical trials. The purpose of RCA is to understand why a problem occurred so that corrective and preventive actions (CAPA) can be implemented effectively. Focusing on issues of non- compliance ensures that the study adheres to GCP and regulatory requirements.
GCP guidelines recommend performing a root cause analysis when deviations or non-compliance are identified to develop effective CAPA plans.
"Root cause analysis focuses on identifying non-compliance issues to implement corrective and preventive measures effectively." Objectives:
* Address non-compliance systematically.
* Develop effective CAPA plans.


NEW QUESTION # 33
During a monitoring visit, a CRA notices that a piece of equipment required for the study needs to be serviced. Who is responsible for addressing this problem?

  • A. CRC
  • B. Sponsor
  • C. PI
  • D. CRA

Answer: C

Explanation:
The Principal Investigator (PI) is responsible for ensuring that all equipment used in the clinical trial is properly maintained and serviced. If a monitor (CRA) identifies equipment that needs servicing, the PI must take immediate action to ensure the equipment is in working order to maintain the quality and integrity of the study data.
GCP guidelines emphasize the PI's responsibility to ensure that all equipment used in the study is functional, properly calibrated, and serviced as needed.
"The PI is responsible for maintaining the functionality and calibration of study-related equipment to ensure accurate data collection." Objectives:
Maintain equipment functionality to ensure data accuracy.
Ensure proper maintenance as part of site management.


NEW QUESTION # 34
A clinical trial is conducted to measure the effectiveness of music therapy to reduce anxiety in intensive care unit patients. Patients are randomly assigned to receive headphones with music of their choice or headphones with white noise. The group receiving the white noise headphones is considered which type of control group?

  • A. No treatment
  • B. Active control
  • C. Placebo
  • D. Alternate dose

Answer: C

Explanation:
In this trial, the white noise group acts as a placebo control. While they are receiving an intervention (white noise), it is not the active therapeutic intervention (music therapy) being tested. Placebo controls help in assessing the effect of the active intervention by comparing it to a neutral or non-therapeutic alternative.
GCP guidelines state that a placebo control is a neutral intervention used to compare the effects of an active treatment.
"A placebo group is one that receives a neutral intervention, used to measure the efficacy of the active intervention by comparison." Objectives:
* Differentiate between active and placebo control groups.
* Evaluate therapeutic efficacy objectively.


NEW QUESTION # 35
During a multi-center, double-blind, placebo-controlled Phase III clinical trial evaluating a novel oncology drug, the following situation occurs:
An interim analysis performed by the DSMB reveals that the investigational product (IP) shows a statistically significant improvement in progression-free survival (PFS) compared to the placebo. However, a sub-group analysis indicates a higher incidence of Grade 4 hepatotoxicity in patients with pre-existing mild liver dysfunction.
The sponsor, upon reviewing the DSMB report, decides to unblind the affected sub-group to assess safety.
The trial protocol specifies that unblinding should only occur if a life-threatening situation is identified.
What is the most appropriate next step the sponsor should take?

  • A. Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.
  • B. Conduct an urgent protocol amendment to include specific monitoring for hepatotoxicity and submit to the IRB/IEC.
  • C. Immediately unblind the entire trial to ensure patient safety.
  • D. Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.

Answer: A

Explanation:
In this situation, the correct course of action is to request the DSMB to conduct a thorough risk assessment and provide recommendations on unblinding the affected sub-group.
* Reasoning:
* The trial protocol specifies that unblinding should only occur if a life-threatening situation arises.
Since the observed hepatotoxicity, although severe, does not automatically qualify as life- threatening, it is prudent to proceed cautiously.
* Immediate unblinding of the entire trial (Option A) would compromise the study's integrity and could introduce bias.
* Submitting the DSMB findings to the IRB/IEC (Option B) without first conducting a more thorough risk assessment may delay necessary safety measures.
* Conducting a protocol amendment (Option C) without a comprehensive risk assessment may be premature.
* Role of the DSMB:
* The DSMB is responsible for evaluating safety data and making independent recommendations to protect trial participants. In this case, the DSMB should analyze the risk/benefit ratio of continuing the trial with the current protocol versus implementing safety modifications.
* Ethical Considerations:
* Protecting patient safety is paramount, but any unblinding must be justified by a clear and imminent risk. The DSMB's independent judgment is critical to making this decision without sponsor influence.
Verified Answer from Official Source:
According to GCP guidelines, any decision to unblind a study must be based on a comprehensive safety assessment, and the DSMB plays a key role in making unbiased recommendations regarding unblinding.
Exact Extract:
"Unblinding in a clinical trial should only occur when justified by critical safety concerns, as recommended by an independent data monitoring committee." Objectives:
* Maintain trial integrity while safeguarding patient safety.
* Follow protocol and regulatory requirements for unblinding.
* Ensure independent decision-making by the DSMB to avoid sponsor bias.


NEW QUESTION # 36
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