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[General] Updated ACRP-CP Free Exam Help You to Get Acquainted with Real ACRP-CP Exam Simu

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【General】 Updated ACRP-CP Free Exam Help You to Get Acquainted with Real ACRP-CP Exam Simu

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ACRP Certified Professional Exam Sample Questions (Q16-Q21):NEW QUESTION # 16
When designing a clinical trial, why is it important to define the study population?
  • A. To support subject recruitment to the study
  • B. To determine where to conduct the study
  • C. To determine the study objectives
  • D. To support the study objectives
Answer: D
Explanation:
Defining the study population is crucial because it ensures that the trial targets the appropriate group for evaluating the investigational product (IP). A well-defined population supports the study objectives by providing reliable and interpretable data that can address the research questions.
GCP guidelines emphasize the need for a clearly defined study population to ensure the generalizability and accuracy of trial results.
"The study population must be clearly defined to ensure that the trial data are relevant and applicable to the intended patient group." Objectives:
* Enhance the scientific validity of clinical trial outcomes.
* Support the accurate interpretation of efficacy and safety data.

NEW QUESTION # 17
AEs that occur between study visits of a clinical trial should be evaluated by the:
  • A. Subject's primary care physician
  • B. Medical monitor
  • C. Principal Investigator
  • D. Study pharmacovigilance physician
Answer: C
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 # 18
Who ensures information regarding payments to subjects is documented in a written consent form?
  • A. Sponsor
  • B. Coordinator
  • C. IRB/IEC
  • D. PI
Answer: C
Explanation:
The IRB/IEC is responsible for reviewing and approving the consent form, which must include any information about payments to participants. This ensures transparency and ethical compliance regarding compensation.
The answer is verified according to GCP guidelines, which mandate IRB/IEC review of consentforms, including payment details.
"IRB/IEC must ensure that the informed consent process is thorough and includes disclosure of any compensation or payment to participants." Objectives:
* Guaranteeing informed consent quality
* Ensuring transparency about participant payments

NEW QUESTION # 19
An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results. Who should perform a root cause analysis and implement appropriatecorrective and preventive actions?
  • A. Sponsor
  • B. IRB/IEC
  • C. DSMB/IDMC
  • D. PI
Answer: D
Explanation:
The Principal Investigator (PI) is responsible for conducting a root cause analysis when non-compliance is identified at the site. The PI must identify the reasons for non-compliance and develop a Corrective and Preventive Action (CAPA) plan to address and prevent future occurrences.
This answer aligns with GCP principles that designate the PI as responsible for site-level compliance and corrective actions.
"The PI must take responsibility for investigating the cause of non-compliance and developing a CAPA plan to mitigate recurrence." Objectives:
* Maintaining compliance and data integrity
* Addressing non-compliance proactively

NEW QUESTION # 20
A Phase I drug trial has been completed and preparations are being made to proceed to a Phase II trial. Who is responsible for revising the IB with this updated information?
  • A. Investigator
  • B. Health authority
  • C. DSMB/IDMC
  • D. Sponsor
Answer: D
Explanation:
The sponsor is responsible for updating the Investigator's Brochure (IB) with new information obtained from the completed Phase I trial. The IB must reflect the most current data on the drug's safety, efficacy, and dosing to support Phase II planning and execution.
According to GCP guidelines, the sponsor must ensure that the IB is updated regularly with relevant findings from ongoing and completed trials.
"The sponsor is responsible for ensuring that the Investigator's Brochure is updated with the latest safety and efficacy data before advancing to the next phase of the trial." Objectives:
* Keep the IB current and accurate.
* Inform investigators of the latest safety and efficacy data.

NEW QUESTION # 21
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