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ACRP Certified Professional Exam Sample Questions (Q34-Q39):

NEW QUESTION # 34
A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?

A. Notify the regulatory authority.
B. Notify the sponsor.
C. Withdraw the subject.
D. Notify the subject.

Answer: B

Explanation:
When a protocol deviation is identified, especially one involving inclusion criteria, the sponsor must be notified immediately. The sponsor will assess the deviation and determine whether the subject can continue in the study. Early notification ensures appropriate action and compliance with protocol and regulatory guidelines.
This answer aligns with GCP principles that mandate sponsor notification in case of protocol deviations, especially when they may impact participant safety or data integrity.
"Any deviation from the protocol that affects subject eligibility must be reported to the sponsor immediately for evaluation and guidance." Objectives:
* Maintain adherence to protocol inclusion criteria.
* Report deviations promptly for safety assessment.

NEW QUESTION # 35
Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?

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

Answer: A

Explanation:
The sponsor is responsible for ensuring that agreements are in place with all involved parties (including investigators and institutions) to grant direct access to trial-related source documents. This is crucial for monitoring, auditing, and inspection purposes, ensuring transparency and compliance with regulatory requirements.
According to GCP guidelines, the sponsor must establish agreements to secure direct access to trial data for verification and compliance checks.
"The sponsor should ensure that agreements are in place to permit direct access to source data and documents for monitoring and inspection." Objectives:
* Maintain compliance with regulatory requirements.
* Facilitate data verification and quality assurance.

NEW QUESTION # 36
An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?

A. Regulatory authority
B. Investigator at each site
C. Study sponsor
D. Original reporting investigator

Answer: C

Explanation:
The study sponsor is responsible for disseminating information about SAEs to all participating sites. This ensures consistent and timely communication of safety concerns, allowing each site to take appropriate actions in line with local regulations and IRB/IEC requirements.
The answer aligns with ICH E6(R2) GCP guidelines which mandate the sponsor to communicatesafety information to all investigators and sites involved in a multicenter trial.
"The sponsor must inform all investigators of safety information that could affect the conduct of the trial or the safety of subjects." Objectives:
* Maintain consistent safety reporting across all trial sites.
* Ensure regulatory compliance in multicenter trials.

NEW QUESTION # 37
In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?

A. CRC
B. PI
C. IRB/IEC
D. CRA

Answer: B

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 # 38
Which of the following should be considered when implementing a risk-based monitoring plan?

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

Answer: C

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 # 39
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