ACRP-CP Dumps with Practice Exam Questions Answers

The IRB/IEC should include at least one member who is not affiliated with the institution or trial site to ensure impartiality and objectivity in the review process. This helps maintain ethical oversight without internal biases influencing the decisions.

This answer is based on ICH E6(R2) GCP guidelines, which mandate the inclusion of non-affiliatedmembers to uphold the integrity of the ethical review process.

"The IRB/IEC should include at least one member who is not associated with the institution to provide an unbiased perspective."

Objectives:

Maintain impartiality in ethical review.

Ensure diverse representation within the IRB/IEC.

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.

The high rate of screen failures indicates that the inclusion/exclusion criteria may be too stringent or not appropriately defined. The sponsor should evaluate the reasons for these failures and determine whether the protocol needs adjustment. Revising the criteria may increase recruitment efficiency without compromising the scientific validity of the study.

GCP guidelines advise reviewing and possibly revising protocols when screen failure rates are significantly high to ensure feasible recruitment.

"If a high number of screen failures occurs, the sponsor should evaluate the inclusion/exclusion criteria and consider protocol revisions."

Objectives:

Improve recruitment efficiency.

Adapt protocol criteria to real-world conditions.

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 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.