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ACRP Certified Professional Exam Sample Questions (Q82-Q87):NEW QUESTION # 82
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 # 83
A deferred consent can take place in which of the following situations?
  • A. Only when the PI approves such a consent process, regardless of the emergency situation described in the protocol.
  • B. In an emergency situation only, even when this process is not described in the protocol, but the sponsor approves the consent process.
  • C. In an emergency situation only, when this process is described in the protocol and has received permission from the ethics committee.
  • D. Only when the PI approves such a consent process immediately prior to patient enrollment, regardless of the situation being classed as emergency.
Answer: C
Explanation:
Deferred consent is permissible in emergency situations where immediate intervention is necessary and obtaining prior consent is not feasible. However, this practice must be explicitly described in the protocol and approved by the ethics committee. This ensures that the rights of patients are protected even in urgent circumstances.
GCP guidelines emphasize that deferred consent is only allowed when pre-approved by the ethics committee as part of the protocol for emergency interventions.
"In emergencies, deferred consent is permitted only if outlined in the protocol and approved by the ethics committee, ensuring compliance with ethical standards." Objectives:
* Protect patient rights in emergency research.
* Ensure ethical approval for deferred consent.

NEW QUESTION # 84
After enrolling and treating a few subjects on an investigator-initiated trial, the PI would like to include a subject diary for each trial subject to capture their activities and experiences on the trial regimen. After the PI has generated a diary, what should the PI do next?
  • A. Submit the diary to the sponsor for approval.
  • B. No approval is necessary: give the diary to each subject.
  • C. Submit the diary to the IRB/IEC for approval.
  • D. Submit the diary to the regulatory authority for approval.
Answer: C
Explanation:
Any new data collection tool introduced during a clinical trial, including subject diaries, must be reviewed and approved by the IRB/IEC before implementation. This ensures that the new tool is ethically appropriate, respects subject privacy, and aligns with the approved protocol.
This answer aligns with ICH E6(R2) GCP guidelines, which mandate IRB/IEC approval for any new or modified subject-related documents introduced during a trial.
"All changes in study documents, including subject diaries, must be submitted for IRB/IEC review to ensure compliance with ethical standards." Objectives:
* Maintain compliance with IRB/IEC requirements.
* Ensure ethical handling of subject data.

NEW QUESTION # 85
Who determines the age of assent for pediatric studies?
  • A. Sponsor
  • B. PI
  • C. Parent
  • D. IRB/IEC
Answer: D
Explanation:
The IRB/IEC determines the age at which a child is considered capable of providing assent for participation in a clinical trial. This decision is based on local regulations, cultural considerations, and the child's ability to understand the trial's risks and benefits. The age of assent may vary between jurisdictions and is subject to ethical considerations specific to pediatric research.
GCP guidelines emphasize that the IRB/IEC is responsible for setting the criteria for obtaining assent from minors based on ethical and regulatory frameworks.
"The IRB/IEC is responsible for determining the age and circumstances under which pediatric assent is required, considering the child's comprehension level." Objectives:
* Ensure appropriate ethical practices in pediatric research.
* Align with local regulatory requirements for assent.

NEW QUESTION # 86
SAEs must be reported immediately by the site to the:
  • A. Sponsor.
  • B. Regulatory agency.
  • C. IRB/IEC.
  • D. DSMB/IDMC.
Answer: A
Explanation:
Serious Adverse Events (SAEs) must be reported immediately to the sponsor. The sponsor then assesses the severity, causality, and potential impact on the study and decides whether further reporting to regulatory authorities and IRB/IEC is required. Immediate reporting ensures that appropriate actions are taken to safeguard participant safety.
GCP guidelines specify that the site must notify the sponsor immediately about any SAE to ensure timely safety assessment and reporting.
"Sites must report all serious adverse events immediately to the sponsor, who will then determine the appropriate regulatory and ethical reporting requirements." Objectives:
* Ensure rapid reporting of serious adverse events.
* Maintain safety monitoring during the trial.

NEW QUESTION # 87
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