2025 THE BEST ACRP-CP–100% FREE EXAM SIMULATOR | PREMIUM ACRP-CP EXAM

2025 The Best ACRP-CP–100% Free Exam Simulator | Premium ACRP-CP Exam

2025 The Best ACRP-CP–100% Free Exam Simulator | Premium ACRP-CP Exam

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ACRP Certified Professional Exam Sample Questions (Q126-Q131):

NEW QUESTION # 126
Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?

  • A. Quarantine IP without registering in IWRS and request replacement from sponsor.
  • B. Register IP in IWRS, quarantine and notify sponsor of the excursion.
  • C. Register IP in IWRS and continue with subject allocation.
  • D. Dispose of IP and request replacement from sponsor.

Answer: B

Explanation:
If a temperature-controlled IP has experienced a temperature excursion during transport, the appropriate action is to register the IP in the Interactive Web Response System (IWRS), quarantine it to prevent use, and immediately notify the sponsor. This procedure ensures that the IP is not used until the sponsor evaluates its stability and suitability.
GCP guidelines state that any IP affected by a temperature excursion should be quarantined and reported to the sponsor for evaluation.
"Upon identification of a temperature excursion, the IP must be quarantined and reported to the sponsor to determine its usability." Objectives:
* Maintain IP integrity and compliance with storage conditions.
* Follow protocol for managing temperature excursions.


NEW QUESTION # 127
An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:

  • A. Investigators participating in the trial.
  • B. Independent qualified individuals.
  • C. Regulatory authority expert advisors.
  • D. Executive board members.

Answer: B

Explanation:
Interim analysis should be reviewed by independent qualified individuals, such as members of a Data Safety Monitoring Board (DSMB) or Independent Data Monitoring Committee (IDMC). This ensures that the analysis is unbiased and that decisions regarding continuation, modification, or termination of the trial are made objectively.
GCP guidelines emphasize that interim data should be reviewed by an independent committee to prevent bias and ensure participant safety.
"Interim analyses should be conducted by independent experts to maintain objectivity and safeguard trial integrity." Objectives:
* Maintain impartiality during interim analysis.
* Ensure unbiased decision-making regarding trial continuation.


NEW QUESTION # 128
The coding system for a double-blind clinical trial is accessible by the:

  • A. IRB/IEC
  • B. Regulatory authority
  • C. Sponsor
  • D. PI

Answer: C

Explanation:
The sponsor is typically responsible for maintaining the code that links the treatment assignment to participants in a double-blind clinical trial. The code is securely maintained and is only accessible in cases where unblinding is necessary for safety reasons. This process helps to preserve the integrity of the study while allowing for emergency unblinding if needed.
GCP guidelines state that the sponsor should maintain the blind unless unblinding is necessary due to safety concerns or regulatory requirements.
"The sponsor maintains the randomization code and ensures that unblinding occurs only when necessary, to protect the study's integrity." Objectives:
* Maintain the integrity of double-blind trials.
* Allow controlled access to randomization codes.


NEW QUESTION # 129
Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?

  • A. Call the medical monitor.
  • B. Report the AE to the sponsor.
  • C. Consult the IB.
  • D. Administer rescue medication.

Answer: D

Explanation:
In a life-threatening situation, the investigator's first priority is the safety and well-being of the participant.
Administering rescue medication immediately is critical to stabilize the patient, regardless of protocol restrictions. Ethical considerations and patient safety always take precedence over protocol compliance.
GCP guidelines emphasize that subject safety is the primary concern, and appropriate medical care must be administered in emergencies.
"In cases of life-threatening events, the investigator should administer necessary medical interventions to safeguard the subject's health." Objectives:
* Prioritize patient safety in emergency situations.
* Make decisions based on medical necessity rather than protocol restrictions.


NEW QUESTION # 130
Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

  • A. IRB/IEC
  • B. Investigator
  • C. Sponsor
  • D. CRO

Answer: C

Explanation:
The sponsor is responsible for defining, establishing, and allocating all trial-related duties and functions before the trial begins. This includes outlining roles and responsibilities in collaboration with investigators, CROs, and other stakeholders. Proper delegation ensures the trial is conducted according to protocol and regulatory requirements.
This answer is verified based on GCP guidelines, which clearly state that sponsors are responsible for the organization and management of trial-related tasks.
"The sponsor is responsible for allocating duties and functions related to the conduct of the trial, ensuring compliance with regulatory and ethical standards." Objectives:
* Clarify the sponsor's role in clinical trial management
* Define responsibilities in trial planning


NEW QUESTION # 131
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