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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.

Deferred consent is permissible in emergency situations where immediate intervention is necessary and obtaining prior consent is not feasible. However, this practice must be explicitly described in the protocol and approved by the ethics committee. This ensures that the rights of patients are protected even in urgent circumstances.

GCP guidelines emphasize that deferred consent is only allowed when pre-approved by the ethics committee as part of the protocol for emergency interventions.

"In emergencies, deferred consent is permitted only if outlined in the protocol and approved by the ethics committee, ensuring compliance with ethical standards."

Objectives:

Protect patient rights in emergency research.

Ensure ethical approval for deferred consent.

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.

The Principal Investigator (PI) can delegate the responsibility for investigational product (IP) accountability to a pharmacist as long as the pharmacist operates under the PI's supervision. This ensures that the pharmacist's actions remain compliant with the protocol and regulatory requirements.

According to GCP guidelines, the PI retains overall responsibility for IP management, even when tasks are delegated to other qualified staff members.

"The investigator may delegate IP management responsibilities to a pharmacist, provided the pharmacist works under the PI’s direct supervision."

Objectives:

Maintain accountability for investigational products.

Ensure proper delegation of IP responsibilities.

Source data/documentation in clinical trials must meet the ALCOA-C standard: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. This ensures that data is credible, traceable to the source, and maintains integrity throughout the study. These attributes are essential for maintaining high-quality, reliable, and verifiable clinical trial records.

GCP guidelines mandate that source documentation should adhere to the ALCOA-C principles to maintain data integrity and reliability.

"Source data must be attributable, legible, contemporaneous, original, accurate, and complete to meet quality and compliance standards."

Objectives:

Maintain data integrity and reliability.

Adhere to best practices in clinical documentation.

The sponsor is responsible for updating the Investigator's Brochure (IB) with new information obtained from the completed Phase I trial. The IB must reflect the most current data on the drug’s safety, efficacy, and dosing to support Phase II planning and execution.

According to GCP guidelines, the sponsor must ensure that the IB is updated regularly with relevant findings from ongoing and completed trials.

"The sponsor is responsible for ensuring that the Investigator’s Brochure is updated with the latest safety and efficacy data before advancing to the next phase of the trial."

Objectives:

Keep the IB current and accurate.

Inform investigators of the latest safety and efficacy data.

While identifying potential risks, assessing them based on their impact, and setting risk acceptability thresholds are integral parts of a risk management approach, documenting every possible risk scenario is impractical and unnecessary. Instead, focus should be on identifying and managing the most significant and likely risks that could affect the study's quality and safety.

GCP guidelines emphasize identifying, assessing, and controlling critical risks rather than exhaustively documenting all hypothetical scenarios.

"Effective risk management involves identifying key risks, evaluating their impact, and setting control measures, rather than documenting every possible risk."

Objectives:

Implement practical and targeted risk management strategies.

Focus on significant and likely risks rather than hypothetical ones.

Centralized monitoring involves the remote evaluation of data trends, outliers, and inconsistencies across sites. If significant issues are identified through centralized monitoring, it may prompt the need for targeted on-site visits to investigate and resolve the identified issues. This approach optimizes resource utilization and focuses on potential problem areas.

GCP guidelines support the use of centralized monitoring to identify risks that warrant on-site monitoring, promoting efficient and targeted oversight.

"Centralized monitoring can identify data patterns or anomalies that indicate the need for an on-site visit to verify and address the issue."

Objectives:

Enhance monitoring efficiency through data-driven decisions.

Prioritize on-site visits based on identified risks.

The finalized site qualification visit report must be maintained in the sponsor’s trial master file (TMF) as part of the essential documents. The TMF serves as the repository for all documents that demonstrate compliance with the protocol and regulatory requirements. Storing the report in the TMF ensures traceability and documentation of the site's suitability for conducting the trial.

GCP guidelines require that site qualification visit reports be included in the trial master file to maintain comprehensive documentation of site assessments.

"Finalized site qualification visit reports must be stored in the sponsor's trial master file to ensure proper documentation and compliance."

Objectives:

Maintain documentation of site qualifications.

Ensure compliance through comprehensive record-keeping.

The IRB/IEC should include at least one member who is not affiliated with the institution or trial site to ensure impartiality and objectivity in the review process. This helps maintain ethical oversight without internal biases influencing the decisions.

This answer is based on ICH E6(R2) GCP guidelines, which mandate the inclusion of non-affiliatedmembers to uphold the integrity of the ethical review process.

"The IRB/IEC should include at least one member who is not associated with the institution to provide an unbiased perspective."

Objectives:

Maintain impartiality in ethical review.

Ensure diverse representation within the IRB/IEC.