ACRP-CP UPDATED DUMPS - TEST ACRP-CP QUESTIONS ANSWERS

ACRP-CP Updated Dumps - Test ACRP-CP Questions Answers

ACRP-CP Updated Dumps - Test ACRP-CP Questions Answers

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ACRP Certified Professional Exam Sample Questions (Q114-Q119):

NEW QUESTION # 114
AEs that occur between study visits of a clinical trial should be evaluated by the:

  • A. Medical monitor
  • B. Principal Investigator
  • C. Subject's primary care physician
  • D. Study pharmacovigilance physician

Answer: B

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 # 115
Who should vote during the IRB/IEC review and discussion process?

  • A. All IRB/IEC members
  • B. All IRB/IEC members and non-member experts
  • C. All members who were involved in the review and discussion
  • D. All members who were involved in the review and discussion and non-member experts

Answer: C

Explanation:
During the IRB/IEC review process, only members who actively participated in the review and discussion are eligible to vote. This ensures that votes are cast by those who are adequately informed about the study and can make an educated decision. Non-member experts may participate in discussions but do not have voting rights.
GCP guidelines state that voting rights in IRB/IEC meetings are limited to members who have thoroughly reviewed and discussed the study, maintaining unbiased and informed decision-making.
"Only IRB/IEC members who were involved in the review and discussion should participate in the voting process." Objectives:
* Ensure informed voting in ethical review processes.
* Maintain integrity and objectivity in IRB/IEC decisions.


NEW QUESTION # 116
Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

  • A. Training records of site personnel on study protocol, and their study-related duties and functions.
  • B. A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
  • C. Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
  • D. A monitoring report that identifies deviation from the approved protocol.

Answer: A


NEW QUESTION # 117
What would a sponsor use to implement and maintain quality in a study?

  • A. Statistical analysis plan
  • B. Protocol signature pages
  • C. Standard operating procedures
  • D. Clinical trial agreement

Answer: C

Explanation:
Standard Operating Procedures (SOPs) are essential for implementing and maintaining quality in a clinical study. SOPs outline the standardized methods for conducting study-related tasks, ensuring consistency, compliance, and quality across all trial sites. They are critical for training personnel, guiding the conduct of study activities, and maintaining protocol adherence.
GCP guidelines state that sponsors must develop and maintain SOPs to ensure the quality and consistency of clinical trial processes.
"The sponsor should establish SOPs to maintain the quality of clinical trials, covering all aspects of trial conduct, data handling, and safety management." Objectives:
* Ensure consistent and high-quality trial conduct.
* Standardize procedures across trial sites.


NEW QUESTION # 118
Which one of the following is a primary objective of a Phase III study of a new IP?

  • A. To demonstrate or confirm therapeutic benefit
  • B. To establish dose information
  • C. To show superiority over another treatment
  • D. To establish the safety profile

Answer: A

Explanation:
Phase III clinical trials primarily aim to demonstrate or confirm the therapeutic benefit of a new investigational product (IP) compared to standard treatments or placebo. These trials are typically larger and are designed to provide robust evidence of efficacy and further evaluate safety.
According to GCP guidelines, Phase III trials focus on confirming the therapeutic efficacy of the IP in a larger population.
"Phase III trials aim to confirm the therapeutic benefit and safety of the investigational product compared to existing treatments." Objectives:
* Confirm therapeutic efficacy.
* Provide comprehensive safety data.


NEW QUESTION # 119
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