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ACRP Certified Professional Exam Sample Questions (Q23-Q28):

NEW QUESTION # 23
Who is responsible for submitting a protocol amendment to the IRB/IEC?

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

Answer: B

Explanation:
The investigator holds the responsibility for submitting any protocol amendments to the IRB/IEC for review and approval. This step ensures that all changes are ethically evaluated before being implemented, maintaining compliance with regulatory requirements.
According to GCP guidelines, the investigator must submit protocol changes to the IRB/IEC to secure approval before making any modifications to the study.
"The investigator must inform the IRB/IEC of any proposed protocol changes and secure approval prior to implementation." Objectives:
* Maintain ethical oversight in study modifications.
* Adhere to regulatory submission requirements.

NEW QUESTION # 24
While reviewing reports of data completion, the sponsor notices low retention rates at many participating sites. What is an appropriate FIRST action for the sponsor to take?

A. Submit revised ICFs to the IRB/IEC with increased compensation for participants.
B. Require participants to provide documented reason for withdrawal.
C. Interview participants who have dropped out.
D. Meet with the site staff to understand their workflows and to review retention strategies.

Answer: D

Explanation:
Meeting with site staff to understand workflows and retention strategies is the most practical first step. By engaging with the team, the sponsor can identify potential issues affecting retention, such as site-related factors, participant burden, or protocol complexities. Addressing these issues collaboratively can improve retention without needing major protocol changes.
GCP guidelines recommend assessing and understanding site-specific challenges before making procedural changes or protocol amendments.
"Engaging with site staff to discuss retention issues helps identify root causes and develop practical solutions." Objectives:
* Improve participant retention through collaboration.
* Identify and address site-specific challenges.

NEW QUESTION # 25
A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

A. Yes, the PI can perform other imaging scans instead of the PET scans.
B. No, the PI is taking part in too many ongoing studies to participate in this study.
C. Yes, the PI has a sufficient patient population to take part in this study.
D. No, the PI does not have the resources to perform all protocol-required procedures.

Answer: D

Explanation:
The PI lacks access to a PET scanner, a required element for conducting the study according to the protocol.
Without this essential equipment, the PI cannot fully meet the study requirements, making it unsuitable for the sponsor to select this site. Compliance with the protocol's technical requirements is crucial for the trial's success.
GCP guidelines state that investigators must have access to all necessary facilities and equipment to conduct the trial as outlined in the protocol.
"The investigator must have adequate resources, including access to required equipment, to perform the study as specified." Objectives:
Ensure site readiness for protocol requirements.
Prevent protocol deviations due to inadequate resources.

NEW QUESTION # 26
A hospital site is being considered for a trial that requires the IP refrigerator to be continuously monitored using the sponsor-provided Wi-Fi-enabled thermometer. The hospital's Wi-Fi connectivity is inconsistent.
During site selection, how should the CRA proceed?

A. Accept this site and plan to undertake routine safety evaluations of the IP.
B. Before accepting this site, ensure the refrigerator is calibrated and functioning properly.
C. Accept this site and implement and maintain QA and QC systems with written SOPs.
D. Before accepting this site, report the risk to the trial sponsor and await their decision.

Answer: D

Explanation:
Since the Wi-Fi connectivity is inconsistent, the CRA must assess the risk and report it to the trial sponsor for a decision. Accepting the site without proper risk evaluation may compromise the monitoring of the investigational product (IP) storage conditions, affecting trial integrity.
The answer follows GCP guidelines that emphasize assessing potential risks during site selection and involving the sponsor when critical issues arise.
"When faced with site-specific issues that may affect data integrity or product safety, the CRA should consult with the sponsor before making a final decision." Objectives:
* Ensuring proper site selection
* Managing potential risks proactively

NEW QUESTION # 27
A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

A. The number of users with access was not defined.
B. The frequency of data backup was not defined.
C. The number of unique eCRF templates was not specified.
D. The list of comparable technology solutions was not included.

Answer: B

Explanation:
The frequency of data backup is a critical element of an Electronic Data Capture (EDC) system's Standard Operating Procedure (SOP). Ensuring regular and systematic data backup is essential for protecting trial data against loss or corruption. Failure to specify backup frequency indicates a gap in data security management.
GCP guidelines stress that data protection, including regular backups, is essential to maintaining data integrity in clinical trials.
"EDC system SOPs must include clear guidelines on data backup frequency to safeguard the integrity and availability of study data." Objectives:
* Ensure data security through regular backups.
* Maintain data integrity in clinical research.

NEW QUESTION # 28
......

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New ACRP-CP Dumps Book, New ACRP-CP Test Pattern

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ACRP Certified Professional Exam Sample Questions (Q23-Q28):

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