ACRP-CP LATEST EXAM EXPERIENCE & ACRP-CP EXAM QUESTIONS

ACRP-CP Latest Exam Experience & ACRP-CP Exam Questions

ACRP-CP Latest Exam Experience & ACRP-CP Exam Questions

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Tags: ACRP-CP Latest Exam Experience, ACRP-CP Exam Questions, Braindump ACRP-CP Pdf, Latest ACRP-CP Test Online, ACRP-CP Detailed Study Dumps

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ACRP Certified Professional Exam Sample Questions (Q33-Q38):

NEW QUESTION # 33
Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?

  • A. CRC
  • B. CRO
  • C. Investigator
  • D. Sponsor

Answer: D

Explanation:
The sponsor is responsible for ensuring that agreements are in place with all involved parties (including investigators and institutions) to grant direct access to trial-related source documents. This is crucial for monitoring, auditing, and inspection purposes, ensuring transparency and compliance with regulatory requirements.
According to GCP guidelines, the sponsor must establish agreements to secure direct access to trial data for verification and compliance checks.
"The sponsor should ensure that agreements are in place to permit direct access to source data and documents for monitoring and inspection." Objectives:
* Maintain compliance with regulatory requirements.
* Facilitate data verification and quality assurance.


NEW QUESTION # 34
The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

  • A. CRC
  • B. Sponsor
  • C. PI
  • D. Regulatory Agency

Answer: C

Explanation:
When the IRB/IEC decides not to approve a clinical trial, they must notify the Principal Investigator (PI) in writing. This communication ensures that the PI is formally informed of the decision and cantake appropriate actions, such as revising the protocol or addressing the reasons for disapproval.
According to GCP guidelines, the IRB/IEC must communicate any decision regarding the approval status of a study directly to the PI, as the PI is responsible for the conduct of the trial.
"The IRB/IEC should promptly notify the investigator in writing of its decision to approve or disapprove the proposed research activity." Objectives:
* Maintain clear communication between the IRB/IEC and the investigator.
* Ensure timely notification of decisions affecting the study.


NEW QUESTION # 35
A PI on a study is a regular member of the IRB/IEC. Which of the following statements is TRUE regarding their participation in the IRB/IEC discussion and deliberation?

  • A. They cannot be the PI on the clinical study due to conflict of interest.
  • B. They must recuse themselves from the meeting given their dual roles as IRB/IEC member and PI.
  • C. They can attend the meeting, but should not vote/provide opinion on whether to approve the study.
  • D. They can attend the meeting and can vote/provide opinion on whether to approve the study.

Answer: B

Explanation:
If a PI is also a member of the IRB/IEC, they must recuse themselves from the meeting when their own study is being reviewed to avoid conflicts of interest. This practice preserves the objectivity and impartiality of the IRB/IEC's decisions.
The answer is verified based on IRB/IEC operational guidelines, which mandate that members with potential conflicts recuse themselves from discussions and voting.
"To maintain objectivity, IRB/IEC members who have a conflict of interest related to a study must recuse themselves from the review and decision-making process." Objectives:
* Maintain impartiality in IRB/IEC decisions
* Prevent conflicts of interest in clinical trial approval


NEW QUESTION # 36
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 # 37
The sponsor calls the site and informs the research team that they have decided to temporarily suspend the study. What step should the research team take FIRST?

  • A. Inform participant and assure proper care is provided.
  • B. Inform the IRB/IEC of the study closure.
  • C. Schedule participant for early termination visit.
  • D. Inform the monitor of the termination of the study.

Answer: A

Explanation:
When a study is temporarily suspended, the primary responsibility of the research team is to ensure the ongoing care and safety of the enrolled participants. Participants must be informed about the suspension and assured that their health and safety will continue to be monitored.
GCP guidelines prioritize the safety and well-being of participants, which must be maintained even during a temporary suspension.
"In the event of a study suspension, the first priority is to inform the participants and ensure that appropriate care and monitoring are continued." Objectives:
* Protect participant safety during study suspension.
* Maintain clear communication with study participants.


NEW QUESTION # 38
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