Pass the ACRP ACRP Certified Professional ACRP-CP Questions and answers with CertsForce

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 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.

In a clinical trial aimed at assessing whether an IP prevents disease recurrence, the primary endpoint would typically be the "time to occurrence of symptoms" indicating a relapse or recurrence. This endpoint directly measures the IP’s effectiveness in prolonging the symptom-free period.

This answer follows the GCP guideline, which states that primary endpoints should directly reflect the trial's objectives, particularly when evaluating recurrence prevention.

"In trials evaluating recurrence prevention, the primary endpoint should measure the time until recurrence of the target symptoms or condition."

Objectives:

Assess the efficacy of IP in preventing disease recurrence.

Accurately measure the time to recurrence as a primary endpoint.

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.

Informed consent must not include any language that implies a waiver of the participant’s legal rights or releases the investigator, sponsor, or institution from liability for negligence. Such language violates ethical standards and the principles of voluntary participation.

According to GCP guidelines and ethical principles, the informed consent document must not include any clause that waives a participant's legal rights.

"An informed consent form must not include language that waives the participant’s legal rights or releases the sponsor or investigator from liability."

Objectives:

Protect participant rights in clinical trials.

Ensure that consent is given voluntarily and ethically.

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 investigator and institution must allow both monitoring and inspection by the appropriate regulatory authorities and auditing by the sponsor. This dual oversight ensures that the trial complies with regulatory standards and sponsor requirements, thereby maintaining the integrity and validity of the data.

GCP guidelines specify that regulatory authorities have the right to inspect, while sponsors typically conduct audits to verify compliance and data quality.

"The institution should permit monitoring and inspection by regulatory authorities and auditing by the sponsor to ensure compliance with GCP and protocol adherence."

Objectives:

Facilitate monitoring and inspection for compliance.

Ensure trial data integrity and quality assurance.

The subject identification code list, which links the participant’s unique code to their personal information, must be retained only at the site. This list ensures confidentiality and is necessary for identifying participants during follow-up. It is not shared with the sponsor to protect participant privacy.

GCP guidelines mandate that the subject identification code list remains at the site to ensure confidentiality and compliance with data protection regulations.

"The subject identification code list must be securely stored at the site to maintain participant confidentiality."

Objectives:

Safeguard participant confidentiality.

Maintain compliance with data protection policies.

The CRC’s first responsibility is to immediately inform the Principal Investigator (PI), who is responsible for the participant’s medical care. The PI will assess the situation, determine the potential risk, and initiate appropriate clinical actions to ensure the participant's safety. This may include medical evaluation or adjusting the dosing regimen.

According to GCP guidelines, any issue that may affect participant safety should be promptly communicated to the PI to ensure appropriate medical management.

"The investigator must be informed immediately of any events that could compromise participant safety, allowing for prompt clinical decision-making."

Objectives:

Ensure rapid response to dosing errors.

Maintain participant safety as a priority.

In investigator-initiated studies, the PI holds primary responsibility for addressing non-compliance, including root cause analysis and implementation of CAPA plans. This ensures that any issues affecting the study’s integrity are adequately addressed and prevented in the future.

The answer is verified based on ICH E6(R2) guidelines which emphasize the PI’s responsibility for maintaining compliance at the study site.

"The PI must develop and implement corrective and preventive actions when non-compliance is identified during the study."

Objectives:

Maintain compliance in investigator-initiated studies.

Address non-compliance through CAPA.