UPDATED ACRP ACRP-CP CBT | ACRP-CP RELIABLE EXAM PATTERN

Updated ACRP ACRP-CP CBT | ACRP-CP Reliable Exam Pattern

Updated ACRP ACRP-CP CBT | ACRP-CP Reliable Exam Pattern

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Tags: Updated ACRP-CP CBT, ACRP-CP Reliable Exam Pattern, Test ACRP-CP Prep, Reliable ACRP-CP Test Testking, ACRP-CP Dumps Free Download

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ACRP Certified Professional Exam Sample Questions (Q39-Q44):

NEW QUESTION # 39
In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

  • A. Randomization
  • B. Placebo-controlled
  • C. Privacy controls
  • D. Blinding

Answer: A

Explanation:
Randomization is a key element in open-label, parallel group clinical trials to reduce selection bias and ensure that participant allocation is not influenced by investigators. Despite the absence of blinding in open-label studies, randomization maintains the validity and reliability of the results by evenly distributing confounding factors between groups.
GCP guidelines recommend randomization as a core element in clinical trial design to ensure unbiased allocation of participants.
"Randomization in parallel group trials helps minimize selection bias and ensures the comparability of intervention groups." Objectives:
* Maintain scientific rigor through randomization.
* Minimize selection bias in clinical studies.


NEW QUESTION # 40
A study sponsor approaches a facility about participating in their research study. The study sponsor requires use of social media as its sole method of recruitment. The site knows their institutional IRB/IEC does not approve of social media recruiting. How should the site respond?

  • A. Rely on the sponsor to notify the IRB/IEC.
  • B. Recruit for the study without use of social media.
  • C. Use a central IRB/IEC.
  • D. Decline the study.

Answer: D

Explanation:
If the IRB/IEC has a policy that does not permit social media recruiting, the site must adhere to these regulations. Proceeding with a method not approved by the IRB/IEC would violate compliance requirements, so declining the study is the correct course of action.
The answer aligns with IRB/IEC regulations that prioritize ethical and compliant recruitment methods.
"Sites must follow the recruitment methods approved by their IRB/IEC to maintain compliance and ethical standards." Objectives:
* Adhering to ethical recruitment practices.
* Maintaining compliance with IRB/IEC policies.


NEW QUESTION # 41
One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:

  • A. Allowing real-time access for data review in the eCRF.
  • B. Recording data on source documents at the time the data are collected during the conduct of the study.
  • C. Comparing source document data to other data recorded in the same study time period.
  • D. Recording the date and time each data element is entered onto the source document.

Answer: B

Explanation:
Contemporaneous data means that data entries are made at the time of the event or as soon as possible after the event occurs. This practice ensures that the recorded data accurately reflect the participant's condition and study procedures, minimizing recall bias and errors. Maintaining contemporaneous records is a fundamental requirement for ensuring the accuracy and reliability of clinical trial data.
GCP guidelines specify that data should be recorded as close to the time of the event as possible to ensure accuracy and reliability.
"Data must be contemporaneously recorded, meaning they are documented at the time of the occurrence to accurately reflect the study conduct." Objectives:
* Ensure accurate and real-time data capture.
* Maintain data integrity by minimizing recall bias.


NEW QUESTION # 42
A site is starting up a Phase III trial. They have received IRB/IEC approval and have scheduled the SIV. The site cannot begin enrolling subjects until:

  • A. The site receives approval from the medical monitor to begin enrolling.
  • B. A signed clinical trial agreement between the site and sponsor is in place.
  • C. The DSMB meets and the first DSMB meeting report has been issued.
  • D. The CRA has performed source document review and verification at the site.

Answer: B

Explanation:
Before a clinical trial site can begin enrolling participants, there must be a signed clinical trial agreement (CTA) between the site and the sponsor. This agreement outlines the responsibilities, financial arrangements, and expectations between both parties, ensuring that the trial is conducted in compliance with regulatory and ethical standards.
GCP guidelines require that a formal agreement be in place before trial initiation to protect the rights and obligations of both the sponsor and the site.
"Before subject enrollment can commence, the sponsor and site must finalize a clinical trial agreement, establishing legal and ethical commitments." Objectives:
* Ensure proper contractual arrangements before trial initiation.
* Protect legal rights and obligations of involved parties.


NEW QUESTION # 43
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 the monitor of the termination of the study.
  • B. Inform the IRB/IEC of the study closure.
  • C. Schedule participant for early termination visit.
  • D. Inform participant and assure proper care is provided.

Answer: D

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 # 44
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