100% PASS QUIZ 2025 ACRP-CP: NEWEST RELIABLE ACRP CERTIFIED PROFESSIONAL EXAM TEST BOOTCAMP

100% Pass Quiz 2025 ACRP-CP: Newest Reliable ACRP Certified Professional Exam Test Bootcamp

100% Pass Quiz 2025 ACRP-CP: Newest Reliable ACRP Certified Professional Exam Test Bootcamp

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ACRP Certified Professional Exam Sample Questions (Q110-Q115):

NEW QUESTION # 110
An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?

  • A. Discontinue current subjects from the study and monitor subjects for any anticipated safety events.
  • B. Update the IB to add the risk of infection and submit to the sponsor for approval.
  • C. Add the risk of infection to the ICF and submit to the IRB/IEC for review.
  • D. Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.

Answer: D

Explanation:
The investigator must promptly notify the sponsor about the observed safety concerns and the decision to stop the IP administration. This constitutes a protocol deviation that must be reported tothe IRB/IEC for ethical oversight. It is essential to document the deviation accurately and seek guidance on whether to continue or modify the study procedures.
GCP guidelines require that significant deviations impacting participant safety be reported to both the sponsor and the IRB/IEC for appropriate review and action.
"Significant safety-related deviations must be reported promptly to the sponsor and IRB/IEC to ensure proper oversight and participant protection." Objectives:
Ensure prompt reporting of safety concerns.
Maintain compliance with ethical oversight requirements.


NEW QUESTION # 111
A double-blind randomized Phase III trial seeks to recruit 500 subjects in 2 years. At the end of the first year,
150 subjects have been enrolled. Monitoring reports from the first year note 50% of subjects screened were screen failures due to exclusionary lab values. What action should the sponsor take?

  • A. Re-train investigators on recruitment obligations.
  • B. Allocate additional monitoring resources to the trial.
  • C. Reduce the target sample size based on feedback from the sites.
  • D. Evaluate the screen failures to determine if the protocol needs revision.

Answer: D

Explanation:
The high rate of screen failures indicates that the inclusion/exclusion criteria may be too stringent or not appropriately defined. The sponsor should evaluate the reasons for these failures and determine whether the protocol needs adjustment. Revising the criteria may increase recruitment efficiency without compromising the scientific validity of the study.
GCP guidelines advise reviewing and possibly revising protocols when screen failure rates are significantly high to ensure feasible recruitment.
"If a high number of screen failures occurs, the sponsor should evaluate the inclusion/exclusion criteria and consider protocol revisions." Objectives:
* Improve recruitment efficiency.
* Adapt protocol criteria to real-world conditions.


NEW QUESTION # 112
A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

  • A. Sponsor
  • B. Data Manager
  • C. Monitor
  • D. QA Department

Answer: C

Explanation:
After data entry into the Electronic Data Capture (EDC) system, the monitor (typically a Clinical Research Associate - CRA) conducts Source Data Verification (SDV). The monitor compares the data entered in the EDC system with the source documents to ensure accuracy, completeness, and consistency. This step is essential for maintaining data integrity and compliance with GCP standards.
GCP guidelines require that monitors verify data accuracy through SDV as part of routine monitoring responsibilities.
"The monitor is responsible for performing Source Data Verification (SDV) to ensure that the data recorded in the EDC system matches the source documents." Objectives:
* Verify data accuracy in clinical trials.
* Ensure compliance with data management protocols.


NEW QUESTION # 113
A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?

  • A. The IRB/IEC must approve the transfer of duties to a CRO.
  • B. Any trial-related duties can be documented as transferred by verbal agreement.
  • C. Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
  • D. All duties transferred to a CRO should be specified in writing.

Answer: D

Explanation:
When a sponsor transfers specific tasks to a Contract Research Organization (CRO), it must be documented in writing. This formal documentation clearly delineates responsibilities and ensures that both parties are aware of their roles and obligations. Verbal agreements are not sufficient forregulatory compliance.
ICH E6(R2) GCP guidelines mandate that all delegated tasks must be documented formally to ensure clarity and compliance.
"The sponsor should document in writing any responsibilities transferred to a CRO to ensure clear delineation of roles." Objectives:
* Maintain clear documentation of delegated tasks.
* Ensure compliance with regulatory standards.


NEW QUESTION # 114
After the site qualification visit report has been finalized, it must be:

  • A. Included in the PI's regulatory file.
  • B. Kept in the CRO/sponsor's trial master file.
  • C. Sent to the IRB/IEC for review and approval.
  • D. Stored in the sponsor's budgets and contracts file.

Answer: B

Explanation:
The finalized site qualification visit report must be maintained in the sponsor's trial master file (TMF) as part of the essential documents. The TMF serves as the repository for all documents that demonstrate compliance with the protocol and regulatory requirements. Storing the report in the TMF ensures traceability and documentation of the site's suitability for conducting the trial.
GCP guidelines require that site qualification visit reports be included in the trial master file to maintain comprehensive documentation of site assessments.
"Finalized site qualification visit reports must be stored in the sponsor's trial master file to ensure proper documentation and compliance." Objectives:
* Maintain documentation of site qualifications.
* Ensure compliance through comprehensive record-keeping.


NEW QUESTION # 115
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