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ACRP Certified Professional Exam Sample Questions (Q85-Q90):

NEW QUESTION # 85
At a close-out visit, which document should be retained only at the site?

Answer: D

Explanation:
The subject identification code list, which links the participant's unique code to their personal information, must be retained only at the site. This list ensures confidentiality and is necessary for identifying participants during follow-up. It is not shared with the sponsor to protect participant privacy.
GCP guidelines mandate that the subject identification code list remains at the site to ensure confidentiality and compliance with data protection regulations.
"The subject identification code list must be securely stored at the site to maintain participant confidentiality." Objectives:
* Safeguard participant confidentiality.
* Maintain compliance with data protection policies.


NEW QUESTION # 86
Which of the following statements is TRUE about an EDC system?

Answer: C

Explanation:
An Electronic Data Capture (EDC) system must include an audit trail to ensure data integrity. This audit trail records every data entry, modification, and deletion along with timestamps and user identification. It is a critical feature for maintaining traceability and accountability in clinical research, allowing for the reconstruction of data changes and ensuring compliance with Good Clinical Practice (GCP).
GCP guidelines mandate that electronic data systems used in clinical trials must maintain an audit trail to ensure data integrity and traceability.
"An audit trail is essential in an EDC system to document all data entries, changes, and deletions to maintain data integrity." Objectives:
* Ensure data integrity through traceable record-keeping.
* Maintain compliance with regulatory standards.


NEW QUESTION # 87
A site has reported multiple temperature excursions for an IP, primarily because the air conditioning (A/C) gets shut off after business hours. A separate A/C unit cannot be installed in the room where the IP is kept.
What would be the MOST effective long-term mitigation strategy?

Answer: D

Explanation:
Investing in a temperature-controlled IP cabinet is the most effective and sustainable solution for maintaining IP stability. This cabinet can consistently regulate temperature without relying on external A/C systems, thereby minimizing the risk of excursions and ensuring compliance with storage requirements.
GCP guidelines state that IP must be stored under controlled conditions as specified by the protocol and product labeling.
"Temperature-controlled storage units should be used when site environmental conditions are not reliable to maintain IP stability." Objectives:
* Ensure IP stability and compliance.
* Mitigate temperature excursion risks effectively.


NEW QUESTION # 88
In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?

Answer: D

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 # 89
Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?

Answer: D

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 # 90
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