ACRP-CP Test King - Test ACRP-CP Pattern

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ACRP Certified Professional Exam Sample Questions (Q45-Q50):

NEW QUESTION # 45
During a monitoring visit, a CRA notices that a piece of equipment required for the study needs to be serviced. Who is responsible for addressing this problem?

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

Answer: D

Explanation:
The Principal Investigator (PI) is responsible for ensuring that all equipment used in the clinical trial is properly maintained and serviced. If a monitor (CRA) identifies equipment that needs servicing, the PI must take immediate action to ensure the equipment is in working order to maintain the quality and integrity of the study data.
GCP guidelines emphasize the PI's responsibility to ensure that all equipment used in the study is functional, properly calibrated, and serviced as needed.
"The PI is responsible for maintaining the functionality and calibration of study-related equipment to ensure accurate data collection." Objectives:
Maintain equipment functionality to ensure data accuracy.
Ensure proper maintenance as part of site management.

NEW QUESTION # 46
A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?

A. Information to be included in the advertising flyer
B. Availability of qualified staff to conduct the trial
C. Length of time to receive the approved trial device
D. Location of stored trial records

Answer: B

Explanation:
The availability of qualified staff to conduct the trial is essential for maintaining compliance with protocol requirements and ensuring patient safety. Without adequately trained and available staff, the trial's integrity and data quality are compromised.
This answer is based on GCP guidelines emphasizing the importance of having trained and qualified personnel before initiating a trial.
"The PI must ensure that sufficient qualified staff is available to conduct the trial as per the protocol and regulatory requirements." Objectives:
* Assessing resource availability
* Ensuring readiness to initiate a clinical trial

NEW QUESTION # 47
The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:

A. 8 calendar days
B. 30 calendar days
C. 7 calendar days
D. 15 calendar days

Answer: D

Explanation:
The sponsor is required to report serious unexpected adverse events (SAEs) to the regulatory authorities within 15 calendar days from the date of awareness. This reporting period is mandated to ensure that any new safety information that may affect the risk/benefit profile of the investigational product (IP) is promptly communicated, thereby protecting participant safety.
GCP guidelines specify that serious, unexpected, and related AEs must be reported to regulatory authorities within 15 days of being known to the sponsor.
"Serious unexpected adverse reactions that may affect the safety profile of the IP must be reported within 15 calendar days to the regulatory authorities." Objectives:
* Ensure timely reporting of safety information.
* Protect the safety of trial participants.

NEW QUESTION # 48
The sponsor should supply a PI with the IP after:

A. Approval/favorable opinion from IRB/IEC and regulatory authority.
B. Approval of protocol by the sponsor.
C. Submission of documents to IRB/IEC and regulatory authority for review.
D. Approval of protocol by the PI.

Answer: A

Explanation:
The sponsor may only provide the investigational product (IP) after the IRB/IEC and relevant regulatory authorities have approved the protocol. This ensures that the trial complies with ethical and legal standards before initiating IP administration.
According to GCP guidelines, sponsors must wait for all necessary approvals before distributing IP to the trial site.
"The investigational product may only be supplied after obtaining regulatory and IRB/IEC approval to ensure ethical conduct of the trial." Objectives:
* Ensure regulatory compliance before initiating IP distribution.
* Protect participant safety and ethical standards.

NEW QUESTION # 49
Which one of the following is a primary objective of a Phase III study of a new IP?

A. To demonstrate or confirm therapeutic benefit
B. To establish the safety profile
C. To show superiority over another treatment
D. To establish dose information

Answer: A

Explanation:
Phase III clinical trials primarily aim to demonstrate or confirm the therapeutic benefit of a new investigational product (IP) compared to standard treatments or placebo. These trials are typically larger and are designed to provide robust evidence of efficacy and further evaluate safety.
According to GCP guidelines, Phase III trials focus on confirming the therapeutic efficacy of the IP in a larger population.
"Phase III trials aim to confirm the therapeutic benefit and safety of the investigational product compared to existing treatments." Objectives:
* Confirm therapeutic efficacy.
* Provide comprehensive safety data.

NEW QUESTION # 50
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ACRP Certified Professional Exam Sample Questions (Q45-Q50):

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