ACRP ACRP-CP - ACRP Certified Professional Exam

Before destroying any essential documents, the site must obtain written confirmation from the sponsor that these documents are no longer needed. This ensures compliance with regulatory requirements, as some countries may require document retention for longer periods, even after study closure and marketing approval.

GCP guidelines state that the sponsor must confirm in writing that essential documents can be destroyed after ensuring compliance with local regulations.

"Before destroying essential documents, written confirmation from the sponsor is required to ensure compliance with regulatory retention policies."

Objectives:

Maintain compliance with document retention regulations.

Prevent premature destruction of essential trial records.

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

The availability of qualified staff to conduct the trial is essential for maintaining compliance with protocol requirements and ensuring patient safety. Without adequately trained and available staff, the trial’s integrity and data quality are compromised.

This answer is based on GCP guidelines emphasizing the importance of having trained and qualified personnel before initiating a trial.

"The PI must ensure that sufficient qualified staff is available to conduct the trial as per the protocol and regulatory requirements."

Objectives:

Assessing resource availability

Ensuring readiness to initiate a clinical trial

The Principal Investigator (PI) is responsible for ensuring that all site staff involved in the study are adequately trained, even if they were unable to attend the Site Initiation Visit (SIV). This responsibility includes organizing training sessions or providing relevant training materials to maintain consistency and compliance with study protocols.

According to GCP guidelines, the PI must ensure that all staff members involved in the trial are adequately informed and trained on their specific responsibilities.

"The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions."

Objectives:

Maintain consistent training for all clinical staff.

Ensure compliance with study procedures.

A Corrective and Preventive Action (CAPA) plan is implemented to address deviations and prevent them from recurring. In this context, the purpose of the CAPA is to establish a procedure for the Principal Investigator (PI) to ensure proper oversight of protocol deviations. This ensures that all future deviations are appropriately managed, reviewed, and documented according to GCP standards.

The answer is verified from GCP guidelines which emphasize that CAPA should focus on identifying root causes and establishing processes to prevent future deviations.

"A CAPA plan must address the root cause and implement systematic actions to prevent the recurrence of protocol deviations."

Objectives:

Ensuring PI oversight in protocol adherence

Maintaining data integrity through systematic corrective actions

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.

The Investigator’s Brochure (IB) contains comprehensive information about the investigational product (IP), including its pharmacokinetic and pharmacodynamic properties, preclinical and clinical trial data, and any known side effects. The IB provides a scientific basis for the study protocol and helps investigators understand the potential risks and benefits.

GCP guidelines state that the IB must include relevant scientific data, including pharmacokinetic and pharmacodynamic profiles.

"The IB should provide data on the pharmacokinetics and pharmacodynamics of the investigational product to inform clinical practice."

Objectives:

Provide comprehensive data on investigational products.

Support safe and informed clinical decision-making.

The Principal Investigator (PI) is responsible for conducting a root cause analysis when non-compliance is identified at the site. The PI must identify the reasons for non-compliance and develop a Corrective and Preventive Action (CAPA) plan to address and prevent future occurrences.

This answer aligns with GCP principles that designate the PI as responsible for site-level compliance and corrective actions.

"The PI must take responsibility for investigating the cause of non-compliance and developing a CAPA plan to mitigate recurrence."

Objectives:

Maintaining compliance and data integrity

Addressing non-compliance proactively

The PI lacks access to a PET scanner, a required element for conducting the study according to the protocol. Without this essential equipment, the PI cannot fully meet the study requirements, making it unsuitable for the sponsor to select this site. Compliance with the protocol’s technical requirements is crucial for the trial’s success.

GCP guidelines state that investigators must have access to all necessary facilities and equipment to conduct the trial as outlined in the protocol.

"The investigator must have adequate resources, including access to required equipment, to perform the study as specified."

Objectives:

Ensure site readiness for protocol requirements.

Prevent protocol deviations due to inadequate resources.

The sponsor holds the responsibility for overseeing any activities delegated to a Contract Research Organization (CRO). This includes ensuring that all delegated tasks are clearly documented and that the CRO performs them according to regulatory standards and the study protocol.

GCP guidelines state that while the sponsor may delegate tasks to a CRO, the ultimate responsibility for the trial's conduct remains with the sponsor.

"The sponsor retains responsibility for overseeing any delegated tasks to the CRO and must ensure that these responsibilities are appropriately documented."

Objectives:

Clarify delegation of duties in clinical trials.

Maintain sponsor oversight for regulatory compliance.