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More Details About ACRP ACRP-CP Exam Dumps

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ACRP Certified Professional Exam Sample Questions (Q94-Q99):

NEW QUESTION # 94
In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?

A. Sponsor
B. CRA
C. Investigator
D. CRC

Answer: C

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 # 95
A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?

A. Develop a monitoring plan
B. Establish a DSMB/IDMC
C. Draft a CAPA plan
D. Conduct routine investigators' meetings

Answer: B

Explanation:
A Data Safety Monitoring Board (DSMB) or Independent Data Monitoring Committee (IDMC) is established to review ongoing trial data at regular intervals. The DSMB evaluates safety, progress, and efficacy endpoints and makes recommendations to continue, modify, or terminate the study based on interim data. This independent oversight helps ensure participant safety and data integrity throughout the trial.
GCP guidelines recommend forming a DSMB for studies that involve high risks or long durations, ensuring continuous safety monitoring.
"The DSMB is responsible for the periodic review of accumulating data and providing recommendations regarding trial continuation, modification, or termination." Objectives:
* Ensure ongoing safety evaluation.
* Facilitate objective decisions on trial continuation.

NEW QUESTION # 96
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. Sponsor
C. DSMB/IDMC
D. Investigator

Answer: B

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 # 97
IP is dispensed to all subjects who:

A. Need IP for their medical condition.
B. Are eligible to receive it in the trial.
C. Screened for the trial.
D. Consented for the trial.

Answer: B

Explanation:
The investigational product (IP) is only dispensed to subjects who meet the eligibility criteria as defined in the study protocol. Eligibility is confirmed during screening and baseline assessments. Simply consenting to the trial does not guarantee receipt of IP.
According to GCP guidelines, IP dispensing must strictly follow eligibility criteria to maintain protocol compliance and subject safety.
"IP should only be dispensed to subjects who have been deemed eligible according to the protocol's inclusion and exclusion criteria." Objectives:
* Maintain adherence to protocol criteria.
* Protect participant safety by ensuring proper eligibility.

NEW QUESTION # 98
An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results. Who should perform a root cause analysis and implement appropriatecorrective and preventive actions?

A. PI
B. Sponsor
C. IRB/IEC
D. DSMB/IDMC

Answer: A

Explanation:
The Principal Investigator (PI) is responsible for conducting a root cause analysis when non-compliance is identified at the site. The PI must identify the reasons for non-compliance and develop a Corrective and Preventive Action (CAPA) plan to address and prevent future occurrences.
This answer aligns with GCP principles that designate the PI as responsible for site-level compliance and corrective actions.
"The PI must take responsibility for investigating the cause of non-compliance and developing a CAPA plan to mitigate recurrence." Objectives:
* Maintaining compliance and data integrity
* Addressing non-compliance proactively

NEW QUESTION # 99
......

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