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[Hardware] ACRP-CP Guaranteed Questions Answers, VCE ACRP-CP Exam Simulator

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【Hardware】 ACRP-CP Guaranteed Questions Answers, VCE ACRP-CP Exam Simulator

Posted at 1/22/2026 06:00:04      View：49 | Replies：0        Print      Only Author   [Copy Link] 1#
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ACRP Certified Professional Exam Sample Questions (Q91-Q96):NEW QUESTION # 91
A protocol requires participants to take IP for 6 months. The protocol allows for any participants who are noncompliant to be replaced by enrolling additional participants, except if it is due to an AE. The investigator has enrolled 12 participants.
The status of the enrolled participants is as follows:
* 3 participants were withdrawn due to noncompliance
* 1 participant withdrew consent after experiencing severe nausea
* 1 participant had to discontinue IP for an unscheduled hospitalization
* 1 participant who is not returning for visits
* 2 participants completed the 6 months of treatment
* 4 participants currently on IP
How many participants should be replaced?
  • A. 5 participants
  • B. 3 participants
  • C. 6 participants
  • D. 4 participants
Answer: B
Explanation:
Since the protocol specifies that participants withdrawn due to an Adverse Event (AE) should not bereplaced, only the participants withdrawn for noncompliance (3 in total) should be replaced. The participant who withdrew consent due to severe nausea (an AE) and the one who discontinued IP due to hospitalization should not be replaced.
GCP guidelines specify that replacement of subjects should follow the protocol criteria, particularly when AEs are involved.
"Participants withdrawn due to AEs should not be replaced if the protocol stipulates this condition, while noncompliant participants may be replaced." Objectives:
* Follow protocol guidelines for participant replacement.
* Ensure compliance with study criteria.

NEW QUESTION # 92
The process of ensuring and documenting that an electronic data processing system conforms to the sponsor's established requirements for completeness, accuracy, reliability, and consistent intended performance is called:
  • A. Programming
  • B. Quality Assurance
  • C. Quality Control
  • D. Validation
Answer: D
Explanation:
Validation is the process of ensuring that an electronic data processing system meets the sponsor's specifications for completeness, accuracy, reliability, and consistent performance. It involves systematic testing and documentation to demonstrate that the system functions as intended, especially in the context of capturing, processing, and managing clinical trial data.
GCP guidelines specify that validation of electronic systems is crucial to maintain data integrity and compliance with regulatory standards.
"Validation ensures that electronic data systems function according to the sponsor's requirements, maintaining data accuracy and reliability." Objectives:
Maintain data integrity and reliability.
Demonstrate system compliance with regulatory requirements.

NEW QUESTION # 93
Per protocol, participants are scheduled to receive IP, which is calculated based on the participant's current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant's safety?
  • A. Notify the sponsor.
  • B. Notify the PI.
  • C. Report a protocol deviation to the IRB/IEC.
  • D. Call the participant to return for an unscheduled visit.
Answer: B
Explanation:
The CRC's first responsibility is to immediately inform the Principal Investigator (PI), who is responsible for the participant's medical care. The PI will assess the situation, determine the potential risk, and initiate appropriate clinical actions to ensure the participant's safety. This may include medical evaluation or adjusting the dosing regimen.
According to GCP guidelines, any issue that may affect participant safety should be promptly communicated to the PI to ensure appropriate medical management.
"The investigator must be informed immediately of any events that could compromise participant safety, allowing for prompt clinical decision-making." Objectives:
* Ensure rapid response to dosing errors.
* Maintain participant safety as a priority.

NEW QUESTION # 94
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. Health authority
  • B. DSMB/IDMC
  • C. Sponsor
  • D. Investigator
Answer: C
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 # 95
Who on the local site research study team is accountable for the unblinding documentation of IP?
  • A. Pharmacist
  • B. Regulatory manager
  • C. CRC
  • D. PI
Answer: D
Explanation:
The Principal Investigator (PI) is ultimately responsible for maintaining and documenting any unblinding events related to the investigational product (IP). This accountability ensures that any instance where the blind is broken is properly justified, documented, and reported to maintain trial integrity.
GCP guidelines state that the PI must oversee the unblinding process and ensure proper documentation to protect the validity of the trial data.
"The PI is responsible for ensuring that any unblinding of the investigational product is adequately documented and reported according to protocol." Objectives:
* Maintain the integrity of blinded studies.
* Properly document unblinding incidents.

NEW QUESTION # 96
......
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