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How to Crack ACRP ACRP-CP Certification Exam Easily?
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ACRP Certified Professional Exam Sample Questions (Q43-Q48):NEW QUESTION # 43
Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?
- A. Administer rescue medication.
- B. Consult the IB.
- C. Call the medical monitor.
- D. Report the AE to the sponsor.
Answer: A
Explanation:
In a life-threatening situation, the investigator's first priority is the safety and well-being of the participant.
Administering rescue medication immediately is critical to stabilize the patient, regardless of protocol restrictions. Ethical considerations and patient safety always take precedence over protocol compliance.
GCP guidelines emphasize that subject safety is the primary concern, and appropriate medical care must be administered in emergencies.
"In cases of life-threatening events, the investigator should administer necessary medical interventions to safeguard the subject's health." Objectives:
* Prioritize patient safety in emergency situations.
* Make decisions based on medical necessity rather than protocol restrictions.
NEW QUESTION # 44
All of the following are examples of what monitors review EXCEPT:
- A. The signed ICF retained in the participant's study file.
- B. Documentation in the participant's medical record of study drug administration.
- C. Potential patient medical records for eligibility prior to the informed consent process.
- D. Regulatory binder which includes copies of current certifications for all laboratories.
Answer: C
Explanation:
Monitors are responsible for reviewing documents that pertain to study conduct and data integrity,including regulatory binders, informed consent forms (ICFs), and documentation of study drug administration.
However, reviewing potential patient medical records for eligibility prior to the informed consent process is not part of a monitor's responsibilities, as this would violate patient confidentiality and GCP standards.
According to GCP guidelines, monitors should ensure compliance with the protocol and data integrity but should not access non-consented patient records.
"Monitors should verify that only enrolled and consented subjects' data are reviewed, ensuring compliance with privacy regulations." Objectives:
* Understand the scope of monitoring responsibilities.
* Protect patient confidentiality during the monitoring process.
NEW QUESTION # 45
Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?
- A. Risk-based audits of CRO activities as delegated
- B. Pre-qualification assessment of CRO
- C. Co-monitoring of CRO site visits
- D. Central monitoring of data fields by sponsor
Answer: A
Explanation:
Risk-based audits of CRO activities as delegated are considered the most efficient way of overseeing a CRO's management. This approach focuses on evaluating the critical risks that might impact data integrity and participant safety. It allows sponsors to allocate resources to areas with the highest potential for error or deviation, rather than performing exhaustive monitoring of all activities.
The answer is verified as per guidelines on risk-based monitoring strategies, emphasizing targeted and efficient oversight of CRO functions.
"Risk-based monitoring emphasizes focusing on critical study parameters and the risks that have the potential to affect data quality and subject safety." Objectives:
* Efficient management of outsourced clinical trial tasks.
* Ensuring data integrity through targeted audits.
NEW QUESTION # 46
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 needs to be reported to the patient's primary care physician.
- B. This qualifies for prompt reporting to the IRB/IEC within 15 business days.
- C. This qualifies for expedited reporting to the sponsor.
- D. This needs to be reported to the regulatory authorities within 10 business days.
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 # 47
In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?
- A. CRC
- B. CRA
- C. PI
- D. IRB/IEC
Answer: C
Explanation:
In investigator-initiated studies, the PI holds primary responsibility for addressing non-compliance, including root cause analysis and implementation of CAPA plans. This ensures that any issues affecting the study's integrity are adequately addressed and prevented in the future.
The answer is verified based on ICH E6(R2) guidelines which emphasize the PI's responsibility for maintaining compliance at the study site.
"The PI must develop and implement corrective and preventive actions when non-compliance is identified during the study." Objectives:
* Maintain compliance in investigator-initiated studies.
* Address non-compliance through CAPA.
NEW QUESTION # 48
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