ACRP ACRP Certified Professional Exam ACRP-CP Exam Dumps: Updated Questions & Answers (May 2025)

A clinical study protocol must include a clear description of the statistical methods to be used in analyzing the collected data. This ensures that the analysis plan is predefined, unbiased, and statistically sound. The statistical methodology must address how the primary and secondary endpoints will be evaluated.

GCP guidelines require that the protocol clearly outlines statistical methods to ensure accurate and unbiased analysis of trial data.

"The protocol should include a detailed description of the statistical methods employed to ensure the validity of the trial results."

Objectives:

Maintain transparency in data analysis.

Ensure scientific rigor in evaluating study outcomes.

The PI is responsible for ensuring accurate documentation of adverse events (AEs) in the medical chart, including their relationship to the investigational product (IP). If an omission is identified, the PI must correct it by making a dated and signed amendment to maintain data accuracy and completeness.

GCP guidelines state that the PI must maintain accurate and complete records, including the assessment of the relationship between AEs and the IP.

"The investigator must document the assessment of the relationship between the AE and the investigational product to ensure accurate clinical records."

Objectives:

Maintain accuracy in adverse event documentation.

Ensure data integrity through appropriate corrections.

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.

A serious unexpected adverse drug reaction (ADR) is characterized by an event that is not consistent with the information provided in the Investigator’s Brochure (IB). Such reactions may indicate new risks associated with the investigational product and warrant immediate reporting to the sponsor and regulatory authorities.

This answer follows the ICH E6(R2) GCP guidelines, which specify the criteria for reporting serious and unexpected adverse events.

"An unexpected adverse drug reaction is one whose nature or severity is not consistent with the applicable product information (e.g., IB)."

Objectives:

Understanding classification of ADRs

Ensuring timely and accurate reporting of unexpected events

The IRB/IEC is responsible for reviewing and approving the consent form, which must include any information about payments to participants. This ensures transparency and ethical compliance regarding compensation.

The answer is verified according to GCP guidelines, which mandate IRB/IEC review of consentforms, including payment details.

"IRB/IEC must ensure that the informed consent process is thorough and includes disclosure of any compensation or payment to participants."

Objectives:

Guaranteeing informed consent quality

Ensuring transparency about participant payments

Meeting with site staff to understand workflows and retention strategies is the most practical first step. By engaging with the team, the sponsor can identify potential issues affecting retention, such as site-related factors, participant burden, or protocol complexities. Addressing these issues collaboratively can improve retention without needing major protocol changes.

GCP guidelines recommend assessing and understanding site-specific challenges before making procedural changes or protocol amendments.

"Engaging with site staff to discuss retention issues helps identify root causes and develop practical solutions."

Objectives:

Improve participant retention through collaboration.

Identify and address site-specific challenges.

The Principal Investigator (PI) holds ultimate responsibility for ensuring that all study-related functions are conducted by qualified and trained personnel. The PI must verify that staff have the necessary qualifications and training to perform their assigned tasks as outlined in the protocol. This responsibility is crucial for maintaining compliance with GCP and ensuring data integrity.

According to GCP guidelines, the PI must ensure that all staff assisting with the trial are adequately trained and qualified for their roles.

"The investigator is responsible for ensuring that all persons assisting with the trial are qualified by education, training, and experience to perform their respective tasks."

Objectives:

Maintain compliance with GCP requirements.

Ensure qualified personnel conduct study tasks.

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

Before proceeding with any trial-related activities, including subject screening, the site must first obtain IRB/IEC approval. This approval ensures that the study has been reviewed for ethical considerations, risk assessment, and adherence to regulatory requirements. Without IRB/IEC approval, initiating the study would violate ethical guidelines and regulatory standards.

GCP guidelines mandate that no clinical trial procedures, including screening, commence without prior IRB/IEC approval.

"IRB/IEC approval must be obtained before initiating any study-related activities, including screening and subject recruitment."

Objectives:

Ensure ethical compliance before study initiation.

Protect participant rights and safety.

Inclusion and exclusion criteria are designed to ensure that participants are medically appropriate for the study and are not ethically vulnerable. This reduces risks to subjects and ensures that the collected data accurately reflects the target population.

The answer follows GCP principles that emphasize participant safety and data validity through well-defined inclusion/exclusion criteria.

"Inclusion and exclusion criteria are crucial for ensuring the safety of participants and the scientific validity of study results."

Objectives:

Ensuring participant safety.

Maintaining ethical standards in clinical research.