Free Practice Questions for ACRP ACRP-CP Exam

Monitors are responsible for reviewing documents that pertain to study conduct and data integrity,including regulatory binders, informed consent forms (ICFs), and documentation of study drug administration. However, reviewing potential patient medical records for eligibility prior to the informed consent process is not part of a monitor's responsibilities, as this would violate patient confidentiality and GCP standards.

According to GCP guidelines, monitors should ensure compliance with the protocol and data integrity but should not access non-consented patient records.

"Monitors should verify that only enrolled and consented subjects' data are reviewed, ensuring compliance with privacy regulations."

Objectives:

Understand the scope of monitoring responsibilities.

Protect patient confidentiality during the monitoring process.

Validation is the process of ensuring that an electronic data processing system meets the sponsor's specifications for completeness, accuracy, reliability, and consistent performance. It involves systematic testing and documentation to demonstrate that the system functions as intended, especially in the context of capturing, processing, and managing clinical trial data.

GCP guidelines specify that validation of electronic systems is crucial to maintain data integrity and compliance with regulatory standards.

"Validation ensures that electronic data systems function according to the sponsor's requirements, maintaining data accuracy and reliability."

Objectives:

Maintain data integrity and reliability.

Demonstrate system compliance with regulatory requirements.

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.

The sponsor is typically responsible for maintaining the code that links the treatment assignment to participants in a double-blind clinical trial. The code is securely maintained and is only accessible in cases where unblinding is necessary for safety reasons. This process helps to preserve the integrity of the study while allowing for emergency unblinding if needed.

GCP guidelines state that the sponsor should maintain the blind unless unblinding is necessary due to safety concerns or regulatory requirements.

"The sponsor maintains the randomization code and ensures that unblinding occurs only when necessary, to protect the study’s integrity."

Objectives:

Maintain the integrity of double-blind trials.

Allow controlled access to randomization codes.

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.

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

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.

During the IRB/IEC review process, only members who actively participated in the review and discussion are eligible to vote. This ensures that votes are cast by those who are adequately informed about the study and can make an educated decision. Non-member experts may participate in discussions but do not have voting rights.

GCP guidelines state that voting rights in IRB/IEC meetings are limited to members who have thoroughly reviewed and discussed the study, maintaining unbiased and informed decision-making.

"Only IRB/IEC members who were involved in the review and discussion should participate in the voting process."

Objectives:

Ensure informed voting in ethical review processes.

Maintain integrity and objectivity in IRB/IEC decisions.

The loss or disposal of investigational product (IP) must be reported to the sponsor. The sponsor will evaluate the situation and determine the next steps, including whether additional reporting to regulatory authorities or corrective actions are necessary. Reporting to the sponsor ensures that the accountability of the IP is properly documented and managed.

GCP guidelines specify that any loss or disposal of IP should be immediately reported to the sponsor for appropriate action and documentation.

"Any incident involving the loss, mishandling, or disposal of IP should be reported to the sponsor to maintain accurate drug accountability."

Objectives:

Maintain accurate IP accountability.

Comply with sponsor requirements for IP management.