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[General] ACRP-CP Exam Braindumps & ACRP-CP Exam Simulation & ACRP-CP Reliable Que

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【General】 ACRP-CP Exam Braindumps & ACRP-CP Exam Simulation & ACRP-CP Reliable Que

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ACRP Certified Professional Exam Sample Questions (Q76-Q81):NEW QUESTION # 76
A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?
  • A. Availability of qualified staff to conduct the trial
  • B. Length of time to receive the approved trial device
  • C. Information to be included in the advertising flyer
  • D. Location of stored trial records
Answer: A
Explanation:
The availability of qualified staff to conduct the trial is essential for maintaining compliance with protocol requirements and ensuring patient safety. Without adequately trained and available staff, the trial's integrity and data quality are compromised.
This answer is based on GCP guidelines emphasizing the importance of having trained and qualified personnel before initiating a trial.
"The PI must ensure that sufficient qualified staff is available to conduct the trial as per the protocol and regulatory requirements." Objectives:
* Assessing resource availability
* Ensuring readiness to initiate a clinical trial

NEW QUESTION # 77
The investigator/institution should permit:
  • A. Monitoring and inspection by the sponsor, and auditing by the appropriate regulatory authority(ies).
  • B. Monitoring and inspection by the appropriate regulatory authority(ies), and auditing by the sponsor.
  • C. Monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).
  • D. Monitoring and auditing by the appropriate regulatory authority(ies), and inspection by the sponsor.
Answer: B
Explanation:
The investigator and institution must allow both monitoring and inspection by the appropriate regulatory authorities and auditing by the sponsor. This dual oversight ensures that the trial complies with regulatory standards and sponsor requirements, thereby maintaining the integrity and validity of the data.
GCP guidelines specify that regulatory authorities have the right to inspect, while sponsors typically conduct audits to verify compliance and data quality.
"The institution should permit monitoring and inspection by regulatory authorities and auditing by the sponsor to ensure compliance with GCP and protocol adherence." Objectives:
* Facilitate monitoring and inspection for compliance.
* Ensure trial data integrity and quality assurance.

NEW QUESTION # 78
A subject became pregnant 16 weeks into a clinical trial. She has been taking a daily dose of IP since enrollment. The baby was born missing two toes on each foot. How should this be reported by the site?
  • A. This qualifies for prompt reporting to the IRB/IEC within 15 business days.
  • B. This needs to be reported to the regulatory authorities within 10 business days.
  • C. This qualifies for expedited reporting to the sponsor.
  • D. This needs to be reported to the patient's primary care physician.
Answer: C
Explanation:
Any serious adverse event (SAE) that is unexpected, especially those involving congenital anomalies or birth defects, must be reported to the sponsor as an expedited safety report. The reporting should occur immediately to ensure prompt assessment and necessary action.
The answer aligns with ICH E6(R2) GCP guidelines, which require immediate reporting of SAEs related to IP use.
"Expedited reporting to the sponsor is required for unexpected serious adverse drug reactions, particularly those involving congenital anomalies." Objectives:
* Immediate safety reporting.
* Protecting the health of trial participants and their offspring.

NEW QUESTION # 79
Which of the following should be considered when implementing a risk-based monitoring plan?
  • A. Centralized monitoring must be incorporated in any trials.
  • B. 100% source document review is mandatory.
  • C. On-site monitoring frequency may change depending on the quality of the data.
  • D. Monitoring schedule must be pre-defined in the monitoring plan.
Answer: C
Explanation:
Risk-based monitoring focuses on adapting the frequency and intensity of on-site visits based on data quality and site performance. If the data is consistently accurate and reliable, the monitoring frequency may be reduced. Conversely, if issues are identified, more frequent monitoring may be necessary.
GCP guidelines emphasize a flexible approach to monitoring, allowing adjustments based on the risk profile and quality of data collected.
"Risk-based monitoring involves adapting the frequency of on-site visits according to the quality of the data and the site's compliance level." Objectives:
* Implement a dynamic monitoring strategy.
* Enhance efficiency while maintaining data integrity.

NEW QUESTION # 80
In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:
  • A. One member who is independent of the institution/trial site.
  • B. A total of five members.
  • C. One member whose primary area of interest is in the same scientific area.
  • D. One member of the site's QA group.
Answer: A
Explanation:
The IRB/IEC should include at least one member who is not affiliated with the institution or trial site to ensure impartiality and objectivity in the review process. This helps maintain ethical oversight without internal biases influencing the decisions.
This answer is based on ICH E6(R2) GCP guidelines, which mandate the inclusion of non-affiliatedmembers to uphold the integrity of the ethical review process.
"The IRB/IEC should include at least one member who is not associated with the institution to provide an unbiased perspective." Objectives:
* Maintain impartiality in ethical review.
* Ensure diverse representation within the IRB/IEC.

NEW QUESTION # 81
......
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