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[General] ACRP-CP Reliable Exam Blueprint - Test ACRP-CP Answers

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【General】 ACRP-CP Reliable Exam Blueprint - Test ACRP-CP Answers

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ACRP Certified Professional Exam Sample Questions (Q72-Q77):NEW QUESTION # 72
A serious unexpected ADR is one:
  • A. That results in the death of the subject.
  • B. Where the severity of the reaction is not consistent with IB.
  • C. Severity and nature of the reaction is consistent with protocol.
  • D. That does not need to be reported to the IRB/IEC.
Answer: B
Explanation:
A serious unexpected adverse drug reaction (ADR) is characterized by an event that is not consistent with the information provided in the Investigator's Brochure (IB). Such reactions may indicate new risks associated with the investigational product and warrant immediate reporting to the sponsor and regulatory authorities.
This answer follows the ICH E6(R2) GCP guidelines, which specify the criteria for reporting serious and unexpected adverse events.
"An unexpected adverse drug reaction is one whose nature or severity is not consistent with the applicable product information (e.g., IB)." Objectives:
* Understanding classification of ADRs
* Ensuring timely and accurate reporting of unexpected events

NEW QUESTION # 73
All of the following are examples of what monitors review EXCEPT:
  • A. Documentation in the participant's medical record of study drug administration.
  • B. The signed ICF retained in the participant's study file.
  • C. Regulatory binder which includes copies of current certifications for all laboratories.
  • D. Potential patient medical records for eligibility prior to the informed consent process.
Answer: D
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 # 74
Which document confirms the PI's agreement to permit auditing at the study site?
  • A. IB
  • B. Delegation Log
  • C. Protocol
  • D. ICF
Answer: D
Explanation:
The Informed Consent Form (ICF) typically includes a statement indicating that the participant's records may be reviewed by monitors, auditors, and regulatory authorities. This ensures transparency and compliance with regulatory requirements, allowing for audits and inspections when necessary.
This answer follows GCP guidelines which specify that the ICF should include consent for audits and inspections to protect subject confidentiality while ensuring data integrity.
"The ICF must include a statement allowing access to trial data for monitoring, auditing, and regulatory inspection purposes." Objectives:
* Ensure informed consent for data access.
* Facilitate compliance with auditing requirements.

NEW QUESTION # 75
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 regulatory authority for approval.
  • B. Submit the diary to the sponsor for approval.
  • C. Submit the diary to the IRB/IEC for approval.
  • D. No approval is necessary: give the diary to each subject.
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 # 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. Length of time to receive the approved trial device
  • B. Availability of qualified staff to conduct the trial
  • C. Information to be included in the advertising flyer
  • D. Location of stored trial records
Answer: B
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
......
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