ACRP ACRP-CP QUESTIONS - PERFECT EXAM PREPARATION [2025]

ACRP ACRP-CP Questions - Perfect Exam Preparation [2025]

ACRP ACRP-CP Questions - Perfect Exam Preparation [2025]

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Tags: Free Sample ACRP-CP Questions, Test ACRP-CP Valid, Reliable ACRP-CP Braindumps Book, Exam ACRP-CP Forum, ACRP-CP Reliable Dumps Ppt

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ACRP Certified Professional Exam Sample Questions (Q65-Q70):

NEW QUESTION # 65
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. Dispose of IP and request replacement from sponsor.
  • B. Register IP in IWRS and continue with subject allocation.
  • C. Quarantine IP without registering in IWRS and request replacement from sponsor.
  • D. Register IP in IWRS, quarantine and notify sponsor of the excursion.

Answer: D

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 # 66
A study subject inadvertently disposed of IP medication bottles. The site should report this to the:

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

Answer: A

Explanation:
The loss or disposal of investigational product (IP) must be reported to the sponsor. The sponsor will evaluate the situation and determine the next steps, including whether additional reporting to regulatory authorities or corrective actions are necessary. Reporting to the sponsor ensures that the accountability of the IP is properly documented and managed.
GCP guidelines specify that any loss or disposal of IP should be immediately reported to the sponsor for appropriate action and documentation.
"Any incident involving the loss, mishandling, or disposal of IP should be reported to the sponsor to maintain accurate drug accountability." Objectives:
* Maintain accurate IP accountability.
* Comply with sponsor requirements for IP management.


NEW QUESTION # 67
The IB contains which of the following sections?

  • A. Known pharmacokinetic effects
  • B. Participant dosing schedule
  • C. IP preparation instructions
  • D. Participant eligibility criteria

Answer: A

Explanation:
The Investigator's Brochure (IB) contains comprehensive information about the investigational product (IP), including its pharmacokinetic and pharmacodynamic properties, preclinical and clinical trial data, and any known side effects. The IB provides a scientific basis for the study protocol and helps investigators understand the potential risks and benefits.
GCP guidelines state that the IB must include relevant scientific data, including pharmacokinetic and pharmacodynamic profiles.
"The IB should provide data on the pharmacokinetics and pharmacodynamics of the investigational product to inform clinical practice." Objectives:
* Provide comprehensive data on investigational products.
* Support safe and informed clinical decision-making.


NEW QUESTION # 68
Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

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

Answer: C


NEW QUESTION # 69
A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:

  • A. IDMC/DSMB Report
  • B. Clinical Study Report
  • C. Clinical Study Protocol
  • D. Investigator Brochure

Answer: B

Explanation:
A Clinical Study Report (CSR) is a comprehensive document that integrates clinical and statistical data from a clinical trial. It provides a complete and detailed account of the study's methods, results, and conclusions, including safety and efficacy analyses. The CSR is prepared at the end of the trial to summarize the data for regulatory submission and scientific publication.
GCP guidelines state that the CSR should integrate both clinical and statistical information to provide a comprehensive overview of the trial's outcomes.
"The Clinical Study Report contains a complete and integrated presentation of clinical and statistical findings from a clinical trial." Objectives:
* Document trial outcomes comprehensively.
* Facilitate regulatory review and scientific dissemination.


NEW QUESTION # 70
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