100% FREE ACRP-CP–100% FREE EXAM CRAM | HIGH-QUALITY ACRP CERTIFIED PROFESSIONAL EXAM RELIABLE STUDY PLAN

100% Free ACRP-CP–100% Free Exam Cram | High-quality ACRP Certified Professional Exam Reliable Study Plan

100% Free ACRP-CP–100% Free Exam Cram | High-quality ACRP Certified Professional Exam Reliable Study Plan

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ACRP Certified Professional Exam Sample Questions (Q82-Q87):

NEW QUESTION # 82
Who on the local site research study team is accountable for the unblinding documentation of IP?

  • A. PI
  • B. Regulatory manager
  • C. CRC
  • D. Pharmacist

Answer: A

Explanation:
The Principal Investigator (PI) is ultimately responsible for maintaining and documenting any unblinding events related to the investigational product (IP). This accountability ensures that any instance where the blind is broken is properly justified, documented, and reported to maintain trial integrity.
GCP guidelines state that the PI must oversee the unblinding process and ensure proper documentation to protect the validity of the trial data.
"The PI is responsible for ensuring that any unblinding of the investigational product is adequately documented and reported according to protocol." Objectives:
* Maintain the integrity of blinded studies.
* Properly document unblinding incidents.


NEW QUESTION # 83
Which of the following is a conflict of interest for a PI conducting a study?

  • A. A PI who receives payment for the study
  • B. A PI who is a key opinion leader, writes the protocol
  • C. A PI that votes on the IRB/IEC approval of the protocol
  • D. A PI that presents at an investigator meeting

Answer: C

Explanation:
A Principal Investigator (PI) who is involved in voting on the IRB/IEC approval of their own protocol is considered to have a conflict of interest. The IRB/IEC must be independent and impartial when reviewing research proposals. Allowing the PI to vote on their own study compromises the ethical review process. To maintain unbiased decision-making, PIs must recuse themselves from such votes.
GCP guidelines emphasize the importance of avoiding conflicts of interest in the IRB/IEC decision-making process to maintain objectivity and ethical standards.
"A PI should not participate in voting or decision-making processes regarding the approval of their own study to avoid conflicts of interest." Objectives:
* Maintain impartiality in ethical review.
* Prevent conflicts of interest during IRB/IEC processes.


NEW QUESTION # 84
A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:

  • A. IDMC/DSMB Report
  • B. Investigator Brochure
  • C. Clinical Study Protocol
  • D. Clinical Study Report

Answer: D

Explanation:
A Clinical Study Report (CSR) is a comprehensive document that integrates clinical and statistical data from a clinical trial. It provides a complete and detailed account of the study's methods, results, and conclusions, including safety and efficacy analyses. The CSR is prepared at the end of the trial to summarize the data for regulatory submission and scientific publication.
GCP guidelines state that the CSR should integrate both clinical and statistical information to provide a comprehensive overview of the trial's outcomes.
"The Clinical Study Report contains a complete and integrated presentation of clinical and statistical findings from a clinical trial." Objectives:
* Document trial outcomes comprehensively.
* Facilitate regulatory review and scientific dissemination.


NEW QUESTION # 85
Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?

  • A. The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.
  • B. The sponsor is responsible for overseeing any delegated activities to a CRO and ensuring that the delegation of these activities is documented.
  • C. The regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.
  • D. The CRC is responsible for identifying the relationship of an SAE to the IP.

Answer: B

Explanation:
The sponsor holds the responsibility for overseeing any activities delegated to a Contract Research Organization (CRO). This includes ensuring that all delegated tasks are clearly documented and that the CRO performs them according to regulatory standards and the study protocol.
GCP guidelines state that while the sponsor may delegate tasks to a CRO, the ultimate responsibility for the trial's conduct remains with the sponsor.
"The sponsor retains responsibility for overseeing any delegated tasks to the CRO and must ensure that these responsibilities are appropriately documented." Objectives:
* Clarify delegation of duties in clinical trials.
* Maintain sponsor oversight for regulatory compliance.


NEW QUESTION # 86
All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:

  • A. Documenting all possible risk scenarios.
  • B. Controlling risk by setting thresholds of risk acceptability.
  • C. Assessing risk based on study impact.
  • D. Identifying potential study risks.

Answer: A

Explanation:
While identifying potential risks, assessing them based on their impact, and setting risk acceptability thresholds are integral parts of a risk management approach, documenting every possible risk scenario is impractical and unnecessary. Instead, focus should be on identifying and managing the most significant and likely risks that could affect the study's quality and safety.
GCP guidelines emphasize identifying, assessing, and controlling critical risks rather than exhaustively documenting all hypothetical scenarios.
"Effective risk management involves identifying key risks, evaluating their impact, and setting control measures, rather than documenting every possible risk." Objectives:
* Implement practical and targeted risk management strategies.
* Focus on significant and likely risks rather than hypothetical ones.


NEW QUESTION # 87
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