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ACRP Certified Professional Exam Sample Questions (Q39-Q44):

NEW QUESTION # 39
Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?

A. Administer rescue medication.
B. Report the AE to the sponsor.
C. Consult the IB.
D. Call the medical monitor.

Answer: A

Explanation:
In a life-threatening situation, the investigator's first priority is the safety and well-being of the participant.
Administering rescue medication immediately is critical to stabilize the patient, regardless of protocol restrictions. Ethical considerations and patient safety always take precedence over protocol compliance.
GCP guidelines emphasize that subject safety is the primary concern, and appropriate medical care must be administered in emergencies.
"In cases of life-threatening events, the investigator should administer necessary medical interventions to safeguard the subject's health." Objectives:
* Prioritize patient safety in emergency situations.
* Make decisions based on medical necessity rather than protocol restrictions.

NEW QUESTION # 40
In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?

A. CRA
B. PI
C. CRC
D. IRB/IEC

Answer: B

Explanation:
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.

NEW QUESTION # 41
A protocol amendment is needed to collect additional data from a participant's medical record. When can the research team begin collecting the additional data?

A. After the original planned data collection is completed
B. After the protocol amendment is approved by the IRB/IEC
C. When the need for the additional data is discovered
D. As soon as the protocol amendment is submitted to the IRB/IEC

Answer: B

Explanation:
The research team must wait until the protocol amendment is reviewed and approved by the IRB/IEC before collecting any additional data. This ensures that any changes to the data collection process have undergone ethical review and comply with regulatory requirements. Collecting data without IRB/IEC approval would be a violation of Good Clinical Practice (GCP).
GCP guidelines clearly state that any changes to the protocol, including additional data collection, must be approved by the IRB/IEC before implementation.
"Any amendment that affects participant data collection must receive IRB/IEC approval before the change is implemented." Objectives:
* Maintain compliance with ethical standards.
* Protect participants' rights and data integrity.

NEW QUESTION # 42
A double-blind randomized Phase III trial seeks to recruit 500 subjects in 2 years. At the end of the first year,
150 subjects have been enrolled. Monitoring reports from the first year note 50% of subjects screened were screen failures due to exclusionary lab values. What action should the sponsor take?

A. Re-train investigators on recruitment obligations.
B. Reduce the target sample size based on feedback from the sites.
C. Evaluate the screen failures to determine if the protocol needs revision.
D. Allocate additional monitoring resources to the trial.

Answer: C

Explanation:
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.

NEW QUESTION # 43
Which one of the following is a primary objective of a Phase III study of a new IP?

A. To demonstrate or confirm therapeutic benefit
B. To show superiority over another treatment
C. To establish the safety profile
D. To establish dose information

Answer: A

Explanation:
Phase III clinical trials primarily aim to demonstrate or confirm the therapeutic benefit of a new investigational product (IP) compared to standard treatments or placebo. These trials are typically larger and are designed to provide robust evidence of efficacy and further evaluate safety.
According to GCP guidelines, Phase III trials focus on confirming the therapeutic efficacy of the IP in a larger population.
"Phase III trials aim to confirm the therapeutic benefit and safety of the investigational product compared to existing treatments." Objectives:
* Confirm therapeutic efficacy.
* Provide comprehensive safety data.

NEW QUESTION # 44
......

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