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[General] ACRP ACRP-CP Web-Based Practice Exam - Reliable Online Self-Assessment Test

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【General】 ACRP ACRP-CP Web-Based Practice Exam - Reliable Online Self-Assessment Test

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ACRP Certified Professional Exam Sample Questions (Q78-Q83):NEW QUESTION # 78
A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?
  • A. Allow access to the entire records.
  • B. Consult with the IRB/IEC first.
  • C. Redact subject identification for privacy protection.
  • D. Deny the request until the sponsor approves.
Answer: A
Explanation:
Regulatory authorities have the legal right to inspect clinical trial records, including identifiable information, even if the study has been closed out. After verifying the inspector's credentials, the site personnel must grant access to all requested documents to ensure compliance with regulations.
According to GCP guidelines, regulatory authorities have the right to access trial-related documents and data during inspections.
"Investigators must grant access to study records when requested by regulatory authorities as part of their inspection rights." Objectives:
* Ensure compliance with inspection requirements.
* Maintain transparency with regulatory authorities.

NEW QUESTION # 79
The investigator/institution should permit:
  • A. Monitoring and inspection by the appropriate regulatory authority(ies), and auditing by the sponsor.
  • B. Monitoring and auditing by the appropriate regulatory authority(ies), and inspection by the sponsor.
  • C. Monitoring and inspection by the sponsor, and auditing by the appropriate regulatory authority(ies).
  • D. Monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).
Answer: A
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 # 80
AEs that occur between study visits of a clinical trial should be evaluated by the:
  • A. Principal Investigator
  • B. Subject's primary care physician
  • C. Medical monitor
  • D. Study pharmacovigilance physician
Answer: A
Explanation:
The Principal Investigator (PI) is responsible for evaluating Adverse Events (AEs) that occur between study visits. The PI must assess the severity, causality, and potential relationship to the investigational product (IP).
Proper evaluation ensures that any necessary medical interventions are promptly administered and that relevant information is recorded and reported accurately.
GCP guidelines specify that the PI is accountable for the medical care of trial subjects, including evaluating AEs and ensuring their safety.
"The PI must evaluate any adverse events occurring between study visits to determine their relevance to the investigational product and manage patient care." Objectives:
* Ensure prompt and accurate evaluation of AEs.
* Maintain the safety and well-being of study participants.

NEW QUESTION # 81
In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?
  • A. CRC
  • B. Sponsor
  • C. CRA
  • D. Investigator
Answer: D
Explanation:
The Principal Investigator (PI) holds ultimate responsibility for ensuring that all study-related functions are conducted by qualified and trained personnel. The PI must verify that staff have the necessary qualifications and training to perform their assigned tasks as outlined in the protocol. This responsibility is crucial for maintaining compliance with GCP and ensuring data integrity.
According to GCP guidelines, the PI must ensure that all staff assisting with the trial are adequately trained and qualified for their roles.
"The investigator is responsible for ensuring that all persons assisting with the trial are qualified by education, training, and experience to perform their respective tasks." Objectives:
* Maintain compliance with GCP requirements.
* Ensure qualified personnel conduct study tasks.

NEW QUESTION # 82
An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?
  • A. Update the IB to add the risk of infection and submit to the sponsor for approval.
  • B. Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
  • C. Add the risk of infection to the ICF and submit to the IRB/IEC for review.
  • D. Discontinue current subjects from the study and monitor subjects for any anticipated safety events.
Answer: B
Explanation:
The investigator must promptly notify the sponsor about the observed safety concerns and the decision to stop the IP administration. This constitutes a protocol deviation that must be reported tothe IRB/IEC for ethical oversight. It is essential to document the deviation accurately and seek guidance on whether to continue or modify the study procedures.
GCP guidelines require that significant deviations impacting participant safety be reported to both the sponsor and the IRB/IEC for appropriate review and action.
"Significant safety-related deviations must be reported promptly to the sponsor and IRB/IEC to ensure proper oversight and participant protection." Objectives:
Ensure prompt reporting of safety concerns.
Maintain compliance with ethical oversight requirements.

NEW QUESTION # 83
......
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