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ACRP-CP real questions - Testking real exam - ACRP Certified Professional Exam VCE

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ACRP Certified Professional Exam Sample Questions (Q42-Q47):

NEW QUESTION # 42
The inclusion and exclusion criteria are in place so all subjects are:

A. Medically appropriate and protected from ethical vulnerability.
B. Patients with the disease under study and will not have any adverse events.
C. Healthy and willing to complete the clinical trial.
D. Ethically vulnerable and patients with the disease under study.

Answer: A

Explanation:
Inclusion and exclusion criteria are designed to ensure that participants are medically appropriate for the study and are not ethically vulnerable. This reduces risks to subjects and ensures that the collected data accurately reflects the target population.
The answer follows GCP principles that emphasize participant safety and data validity through well-defined inclusion/exclusion criteria.
"Inclusion and exclusion criteria are crucial for ensuring the safety of participants and the scientific validity of study results." Objectives:
* Ensuring participant safety.
* Maintaining ethical standards in clinical research.

NEW QUESTION # 43
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. Data Manager
B. Monitor
C. Sponsor
D. QA Department

Answer: B

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 # 44
When assessing the monitoring needs for a study, sponsors should:

A. Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.
B. Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
C. Permit PIs to select a monitor for their site as long as they are independent of the PI.
D. Use central monitoring instead of conducting physical monitoring visits at sites.

Answer: A

Explanation:
Sponsors must ensure that monitors are adequately qualified, possessing the necessary scientific and clinical knowledge to effectively oversee the trial. This ensures that monitors can accurately assess protocol compliance, data integrity, and participant safety. The quality of monitoring directly impacts the credibility of the trial outcomes.
GCP guidelines specify that monitors must be adequately trained and knowledgeable about the trial protocol, investigational product (IP), and clinical research standards.
"The sponsor must ensure that monitors have appropriate qualifications and training to conduct effective trial monitoring." Objectives:
* Maintain data integrity through skilled monitoring.
* Ensure patient safety and protocol compliance.

NEW QUESTION # 45
Which of the following should be considered when implementing a risk-based monitoring plan?

A. Monitoring schedule must be pre-defined in the monitoring plan.
B. 100% source document review is mandatory.
C. Centralized monitoring must be incorporated in any trials.
D. On-site monitoring frequency may change depending on the quality of the data.

Answer: D

Explanation:
Risk-based monitoring focuses on adapting the frequency and intensity of on-site visits based on data quality and site performance. If the data is consistently accurate and reliable, the monitoring frequency may be reduced. Conversely, if issues are identified, more frequent monitoring may be necessary.
GCP guidelines emphasize a flexible approach to monitoring, allowing adjustments based on the risk profile and quality of data collected.
"Risk-based monitoring involves adapting the frequency of on-site visits according to the quality of the data and the site's compliance level." Objectives:
* Implement a dynamic monitoring strategy.
* Enhance efficiency while maintaining data integrity.

NEW QUESTION # 46
A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?

A. Deny the request until the sponsor approves.
B. Allow access to the entire records.
C. Redact subject identification for privacy protection.
D. Consult with the IRB/IEC first.

Answer: B

Explanation:
Regulatory authorities have the legal right to inspect clinical trial records, including identifiable information, even if the study has been closed out. After verifying the inspector's credentials, the site personnel must grant access to all requested documents to ensure compliance with regulations.
According to GCP guidelines, regulatory authorities have the right to access trial-related documents and data during inspections.
"Investigators must grant access to study records when requested by regulatory authorities as part of their inspection rights." Objectives:
* Ensure compliance with inspection requirements.
* Maintain transparency with regulatory authorities.

NEW QUESTION # 47
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