Free Practice Questions for ACRP ACRP-CP Exam

The IRB/IEC's primary responsibility when reviewing recruitment materials such as posters, fliers, social media posts, and promotional items is to ensure that these materials safeguard the rights, safety, and well-being of potential participants. This includes ensuring that the information is presented ethically, clearly, and without coercion, maintaining compliance with ethical guidelines.

GCP guidelines require that any materials used for recruitment be reviewed to ensure they do not mislead participants and that they respect their rights and well-being.

"IRB/IEC review of recruitment materials ensures that they protect participants' rights and well-being and that the content is ethically appropriate."

Objectives:

Maintain ethical standards in recruitment.

Protect potential participants from misleading or coercive information.

The primary factor in determining whether a protocol deviation should be reported to the IRB/IEC is whether the deviation impacts participant safety or the integrity of the study data. Any deviation that could pose a risk to participants must be reported promptly to ensure ongoing ethical oversight.

GCP guidelines mandate reporting of any protocol deviations that affect safety or data integrity to the IRB/IEC.

"Protocol deviations that impact the safety of participants or the integrity of the study must be reported to the IRB/IEC."

Objectives:

Maintain participant safety.

Ensure regulatory compliance through prompt reporting.

The investigator must prioritize the subject's immediate health and safety. In a medical emergency, the appropriate response is to advise the ER doctor to proceed with the necessary medical intervention (blood transfusion). Afterward, the PI must promptly report the incident to the sponsor as a protocol deviation.

GCP guidelines emphasize that patient safety takes precedence over protocol requirements in emergency situations.

"In situations where immediate medical intervention is necessary to prevent harm, the investigator should ensure that the appropriate care is given and subsequently report the event as a deviation."

Objectives:

Prioritize patient safety in emergencies.

Report protocol deviations promptly.

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.

Conducting subject-related conversations in controlled environments ensures that personal and sensitive information is not overheard or disclosed to unauthorized individuals. This practice upholds patient confidentiality as required by GCP and data protection regulations.

The answer follows GCP guidelines for protecting the privacy and confidentiality of clinical trial participants.

"Conversations regarding study subjects should be held in secure and controlled environments to protect personal data."

Objectives:

Ensuring confidentiality in clinical trial settings.

Protecting patient privacy according to ethical standards.

Root cause analysis (RCA) is a systematic process aimed at identifying the underlying reasons for non-compliance or errors in clinical trials. The purpose of RCA is to understand why a problem occurred so that corrective and preventive actions (CAPA) can be implemented effectively. Focusing on issues of non-compliance ensures that the study adheres to GCP and regulatory requirements.

GCP guidelines recommend performing a root cause analysis when deviations or non-compliance are identified to develop effective CAPA plans.

"Root cause analysis focuses on identifying non-compliance issues to implement corrective and preventive measures effectively."

Objectives:

Address non-compliance systematically.

Develop effective CAPA plans.

If a PI is also a member of the IRB/IEC, they must recuse themselves from the meeting when their own study is being reviewed to avoid conflicts of interest. This practice preserves the objectivity and impartiality of the IRB/IEC's decisions.

The answer is verified based on IRB/IEC operational guidelines, which mandate that members with potential conflicts recuse themselves from discussions and voting.

"To maintain objectivity, IRB/IEC members who have a conflict of interest related to a study must recuse themselves from the review and decision-making process."

Objectives:

Maintain impartiality in IRB/IEC decisions

Prevent conflicts of interest in clinical trial approval

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.

It is not the monitor’s responsibility to report serious adverse events (SAEs) to the IRB/IEC. This responsibility typically falls on the PI or the sponsor. Monitors focus on data accuracy, protocol compliance, and communication between the site and the sponsor.

The answer follows GCP standards where the monitor’s role is clearly defined, excluding SAE reporting to IRB/IEC.

"Monitors are responsible for verifying data accuracy and communicating with the sponsor but not for direct reporting of SAEs to the IRB/IEC."

Objectives:

Distinguish between the responsibilities of monitors and investigators

Clarify SAE reporting protocols

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.