2025 Study ACRP-CP Center | Accurate 100% Free Valid ACRP Certified Professional Exam Test Cram
2025 Study ACRP-CP Center | Accurate 100% Free Valid ACRP Certified Professional Exam Test Cram
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Tags: Study ACRP-CP Center, Valid ACRP-CP Test Cram, Practice ACRP-CP Test Online, Reliable ACRP-CP Exam Pattern, Reliable ACRP-CP Dumps Ppt
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ACRP Certified Professional Exam Sample Questions (Q63-Q68):
NEW QUESTION # 63
In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?
- A. PI
- B. CRA
- C. CRC
- D. IRB/IEC
Answer: A
Explanation:
In investigator-initiated studies, the PI holds primary responsibility for addressing non-compliance, including root cause analysis and implementation of CAPA plans. This ensures that any issues affecting the study's integrity are adequately addressed and prevented in the future.
The answer is verified based on ICH E6(R2) guidelines which emphasize the PI's responsibility for maintaining compliance at the study site.
"The PI must develop and implement corrective and preventive actions when non-compliance is identified during the study." Objectives:
* Maintain compliance in investigator-initiated studies.
* Address non-compliance through CAPA.
NEW QUESTION # 64
In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?
- A. CRA
- B. Sponsor
- C. CRC
- D. Investigator
Answer: D
Explanation:
The Principal Investigator (PI) holds ultimate responsibility for ensuring that all study-related functions are conducted by qualified and trained personnel. The PI must verify that staff have the necessary qualifications and training to perform their assigned tasks as outlined in the protocol. This responsibility is crucial for maintaining compliance with GCP and ensuring data integrity.
According to GCP guidelines, the PI must ensure that all staff assisting with the trial are adequately trained and qualified for their roles.
"The investigator is responsible for ensuring that all persons assisting with the trial are qualified by education, training, and experience to perform their respective tasks." Objectives:
* Maintain compliance with GCP requirements.
* Ensure qualified personnel conduct study tasks.
NEW QUESTION # 65
Which entity has ultimate responsibility over the conduct of the multi-center clinical trial?
- A. Sponsor-Investigator
- B. IRB/IEC
- C. CRO
- D. Regulatory authority
Answer: A
Explanation:
In a multi-center clinical trial, the Sponsor-Investigator holds ultimate responsibility for the overall conduct of the study. This includes ensuring compliance with the protocol, maintaining data integrity, and overseeing all participating sites. The Sponsor-Investigator must ensure that each site follows the same procedures and standards to maintain consistency across the trial.
According to GCP guidelines, the Sponsor-Investigator must take responsibility for all aspects of a multi- center trial, including site coordination and data management.
"The Sponsor-Investigator assumes ultimate responsibility for the conduct of a multi-center clinical trial, ensuring protocol compliance and data consistency." Objectives:
* Maintain accountability across multi-center sites.
* Ensure uniformity in trial conduct.
NEW QUESTION # 66
Which of the following reports should be retained in participant charts?
- A. Lab reports
- B. DSMB/IDMC reports
- C. IRB/IEC progress reports
- D. Safety reports
Answer: A
Explanation:
Lab reports contain individual participant data relevant to their health status and the study's outcomes. These reports are essential for verifying subject safety and evaluating the effects of the investigational product (IP).
Therefore, they must be retained in the participant's medical records.
According to GCP guidelines, participant charts must include laboratory data as part of the essential documents to ensure accurate and complete clinical records.
"Lab reports must be maintained as part of the participant's chart for safety monitoring and data verification." Objectives:
* Maintain comprehensive medical records for each participant.
* Ensure availability of clinical data for audit and review.
NEW QUESTION # 67
Which of the following should be reviewed and evaluated by qualified experts to assess implications for the safety of the trial subjects?
- A. Project feasibility considerations
- B. PI roles and responsibilities
- C. Sample collection storage, disposal, and shipment requirements
- D. Emerging animal toxicological and clinical data
Answer: D
Explanation:
Qualified experts should evaluate emerging animal toxicological and clinical data to assess potential safety implications for trial subjects. These data are critical in identifying potential risks, adverse effects, or safety concerns before exposing human subjects to the investigational product. Early detection of safety issues through expert evaluation helps protect participant well-being.
GCP guidelines stress the importance of expert assessment of preclinical and clinical data to identify risks and ensure participant safety.
"Emerging toxicological and clinical data should be carefully reviewed by qualified experts to identify safety concerns before clinical use." Objectives:
* Ensure participant safety through expert data analysis.
* Identify potential safety risks early in the trial process.
NEW QUESTION # 68
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