ACRP-CP ACRP Certified Professional Exam Free Practice Exam Questions (2025 Updated)

Before a clinical trial site can begin enrolling participants, there must be a signed clinical trial agreement (CTA) between the site and the sponsor. This agreement outlines the responsibilities, financial arrangements, and expectations between both parties, ensuring that the trial is conducted in compliance with regulatory and ethical standards.

GCP guidelines require that a formal agreement be in place before trial initiation to protect the rights and obligations of both the sponsor and the site.

"Before subject enrollment can commence, the sponsor and site must finalize a clinical trial agreement, establishing legal and ethical commitments."

Objectives:

Ensure proper contractual arrangements before trial initiation.

Protect legal rights and obligations of involved parties.

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.

In a double-blind study, both the participant (subject) and the investigator (or clinical staff administering the treatment) are blinded. This approach minimizes bias in treatment administration and outcome assessment. Blinding the subject ensures that their responses are not influenced by their knowledge of the treatment they are receiving.

According to GCP guidelines, double-blinding is essential to eliminate both participant and investigator bias, ensuring objective trial results.

"Double-blind studies ensure that neither the participant nor the investigator knows which intervention is being administered, thereby minimizing bias."

Objectives:

Maintain the integrity of the study by preventing bias.

Enhance the validity of trial outcomes.

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.

Any serious adverse event (SAE) that is unexpected, especially those involving congenital anomalies or birth defects, must be reported to the sponsor as an expedited safety report. The reporting should occur immediately to ensure prompt assessment and necessary action.

The answer aligns with ICH E6(R2) GCP guidelines, which require immediate reporting of SAEs related to IP use.

"Expedited reporting to the sponsor is required for unexpected serious adverse drug reactions, particularly those involving congenital anomalies."

Objectives:

Immediate safety reporting.

Protecting the health of trial participants and their offspring.

Interim analysis should be reviewed by independent qualified individuals, such as members of a Data Safety Monitoring Board (DSMB) or Independent Data Monitoring Committee (IDMC). This ensures that the analysis is unbiased and that decisions regarding continuation, modification, or termination of the trial are made objectively.

GCP guidelines emphasize that interim data should be reviewed by an independent committee to prevent bias and ensure participant safety.

"Interim analyses should be conducted by independent experts to maintain objectivity and safeguard trial integrity."

Objectives:

Maintain impartiality during interim analysis.

Ensure unbiased decision-making regarding trial continuation.

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.

Since the protocol specifies that participants withdrawn due to an Adverse Event (AE) should not bereplaced, only the participants withdrawn for noncompliance (3 in total) should be replaced. The participant who withdrew consent due to severe nausea (an AE) and the one who discontinued IP due to hospitalization should not be replaced.

GCP guidelines specify that replacement of subjects should follow the protocol criteria, particularly when AEs are involved.

"Participants withdrawn due to AEs should not be replaced if the protocol stipulates this condition, while noncompliant participants may be replaced."

Objectives:

Follow protocol guidelines for participant replacement.

Ensure compliance with study criteria.

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

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.

A Principal Investigator (PI) who is involved in voting on the IRB/IEC approval of their own protocol is considered to have a conflict of interest. The IRB/IEC must be independent and impartial when reviewing research proposals. Allowing the PI to vote on their own study compromises the ethical review process. To maintain unbiased decision-making, PIs must recuse themselves from such votes.

GCP guidelines emphasize the importance of avoiding conflicts of interest in the IRB/IEC decision-making process to maintain objectivity and ethical standards.

"A PI should not participate in voting or decision-making processes regarding the approval of their own study to avoid conflicts of interest."

Objectives:

Maintain impartiality in ethical review.

Prevent conflicts of interest during IRB/IEC processes.

Qualified experts should evaluate emerging animal toxicological and clinical data to assess potential safety implications for trial subjects. These data are critical in identifying potential risks, adverse effects, or safety concerns before exposing human subjects to the investigational product. Early detection of safety issues through expert evaluation helps protect participant well-being.

GCP guidelines stress the importance of expert assessment of preclinical and clinical data to identify risks and ensure participant safety.

"Emerging toxicological and clinical data should be carefully reviewed by qualified experts to identify safety concerns before clinical use."

Objectives:

Ensure participant safety through expert data analysis.

Identify potential safety risks early in the trial process.

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.

An impartial witness is required when a legally acceptable representative (LAR) or the subject themselves cannot read. The witness ensures that the information is presented accurately and that the consent process is conducted ethically. The witness also signs the consent form to confirm that the subject or representative understands the study details.

GCP guidelines require an impartial witness to be present to confirm that the consent information is correctly conveyed and understood when the subject or LAR cannot read.

"An impartial witness is required when the subject or legally acceptable representative is unable to read, ensuring the consent process is transparent and ethically sound."

Objectives:

Protect the rights of individuals with literacy challenges.

Maintain ethical standards in the consent process.

The sponsor is primarily responsible for the ongoing safety evaluation of the investigational product (IP) throughout the clinical trial. This responsibility includes monitoring adverse events, reporting serious adverse events (SAEs) to regulatory authorities, and updating the Investigator’s Brochure (IB) with relevant safety data.

According to GCP guidelines, the sponsor must continuously evaluate safety data and report findings to regulatory bodies as necessary.

"The sponsor is responsible for the continuous safety monitoring of the investigational product and for ensuring that new safety information is communicated to investigators and regulators."

Objectives:

Ensure participant safety throughout the study.

Maintain accurate and timely reporting of safety data.

Lab reports contain individual participant data relevant to their health status and the study's outcomes. These reports are essential for verifying subject safety and evaluating the effects of the investigational product (IP). Therefore, they must be retained in the participant’s medical records.

According to GCP guidelines, participant charts must include laboratory data as part of the essential documents to ensure accurate and complete clinical records.

"Lab reports must be maintained as part of the participant’s chart for safety monitoring and data verification."

Objectives:

Maintain comprehensive medical records for each participant.

Ensure availability of clinical data for audit and review.