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ACRP Certified Professional Exam Sample Questions (Q118-Q123):

NEW QUESTION # 118
A trial subject was involved in a traffic accident. The emergency room (ER) doctor notifies the investigator that he wants to give the subject a blood transfusion. Blood transfusion is one of the prohibited treatments in the trial. How should the investigator respond?

A. Advise the ER doctor to transfuse blood, and the PI should withdraw the subject from the trial.
B. Advise the ER doctor to transfuse the blood, and the PI should report this incident to the sponsor.
C. Report this incident immediately to the sponsor and leave the treatment decision to them.
D. Ask the ER doctor not to transfuse blood and consider another treatment compliant with the protocol.

Answer: B

Explanation:
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.

NEW QUESTION # 119
The composition of an IDMC/DSMB should include which one of the following?

A. A clinical scientist who is knowledgeable in the appropriate discipline
B. A sponsor representative who is knowledgeable about the study's unblinded information
C. A lead PI for the study
D. A member from the IRB/IEC

Answer: A

Explanation:
An Independent Data Monitoring Committee (IDMC) or Data and Safety Monitoring Board (DSMB) should include clinical scientists who are knowledgeable in the relevant medical and scientific areas. Their role is to objectively assess the ongoing safety data and efficacy of the investigational product, ensuring that participants' safety is not compromised.
GCP guidelines emphasize the need for experienced clinical scientists on IDMC/DSMBs to ensure that safety data is interpreted accurately and professionally.
"IDMC/DSMB should comprise independent experts, including clinical scientists, who have the expertise to evaluate safety and efficacy data objectively." Objectives:
* Ensure impartial evaluation of safety data.
* Maintain scientific integrity in monitoring clinical trials.

NEW QUESTION # 120
During a multi-center, double-blind, placebo-controlled Phase III clinical trial evaluating a novel oncology drug, the following situation occurs:
An interim analysis performed by the DSMB reveals that the investigational product (IP) shows a statistically significant improvement in progression-free survival (PFS) compared to the placebo. However, a sub-group analysis indicates a higher incidence of Grade 4 hepatotoxicity in patients with pre-existing mild liver dysfunction.
The sponsor, upon reviewing the DSMB report, decides to unblind the affected sub-group to assess safety.
The trial protocol specifies that unblinding should only occur if a life-threatening situation is identified.
What is the most appropriate next step the sponsor should take?

A. Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.
B. Conduct an urgent protocol amendment to include specific monitoring for hepatotoxicity and submit to the IRB/IEC.
C. Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.
D. Immediately unblind the entire trial to ensure patient safety.

Answer: A

Explanation:
In this situation, the correct course of action is to request the DSMB to conduct a thorough risk assessment and provide recommendations on unblinding the affected sub-group.
* Reasoning:
* The trial protocol specifies that unblinding should only occur if a life-threatening situation arises.
Since the observed hepatotoxicity, although severe, does not automatically qualify as life- threatening, it is prudent to proceed cautiously.
* Immediate unblinding of the entire trial (Option A) would compromise the study's integrity and could introduce bias.
* Submitting the DSMB findings to the IRB/IEC (Option B) without first conducting a more thorough risk assessment may delay necessary safety measures.
* Conducting a protocol amendment (Option C) without a comprehensive risk assessment may be premature.
* Role of the DSMB:
* The DSMB is responsible for evaluating safety data and making independent recommendations to protect trial participants. In this case, the DSMB should analyze the risk/benefit ratio of continuing the trial with the current protocol versus implementing safety modifications.
* Ethical Considerations:
* Protecting patient safety is paramount, but any unblinding must be justified by a clear and imminent risk. The DSMB's independent judgment is critical to making this decision without sponsor influence.
Verified Answer from Official Source:
According to GCP guidelines, any decision to unblind a study must be based on a comprehensive safety assessment, and the DSMB plays a key role in making unbiased recommendations regarding unblinding.
Exact Extract:
"Unblinding in a clinical trial should only occur when justified by critical safety concerns, as recommended by an independent data monitoring committee." Objectives:
* Maintain trial integrity while safeguarding patient safety.
* Follow protocol and regulatory requirements for unblinding.
* Ensure independent decision-making by the DSMB to avoid sponsor bias.

NEW QUESTION # 121
What would a sponsor use to implement and maintain quality in a study?

A. Protocol signature pages
B. Statistical analysis plan
C. Standard operating procedures
D. Clinical trial agreement

Answer: C

Explanation:
Standard Operating Procedures (SOPs) are essential for implementing and maintaining quality in a clinical study. SOPs outline the standardized methods for conducting study-related tasks, ensuring consistency, compliance, and quality across all trial sites. They are critical for training personnel, guiding the conduct of study activities, and maintaining protocol adherence.
GCP guidelines state that sponsors must develop and maintain SOPs to ensure the quality and consistency of clinical trial processes.
"The sponsor should establish SOPs to maintain the quality of clinical trials, covering all aspects of trial conduct, data handling, and safety management." Objectives:
* Ensure consistent and high-quality trial conduct.
* Standardize procedures across trial sites.

NEW QUESTION # 122
A deferred consent can take place in which of the following situations?

A. Only when the PI approves such a consent process immediately prior to patient enrollment, regardless of the situation being classed as emergency.
B. Only when the PI approves such a consent process, regardless of the emergency situation described in the protocol.
C. In an emergency situation only, even when this process is not described in the protocol, but the sponsor approves the consent process.
D. In an emergency situation only, when this process is described in the protocol and has received permission from the ethics committee.

Answer: D

Explanation:
Deferred consent is permissible in emergency situations where immediate intervention is necessary and obtaining prior consent is not feasible. However, this practice must be explicitly described in the protocol and approved by the ethics committee. This ensures that the rights of patients are protected even in urgent circumstances.
GCP guidelines emphasize that deferred consent is only allowed when pre-approved by the ethics committee as part of the protocol for emergency interventions.
"In emergencies, deferred consent is permitted only if outlined in the protocol and approved by the ethics committee, ensuring compliance with ethical standards." Objectives:
* Protect patient rights in emergency research.
* Ensure ethical approval for deferred consent.

NEW QUESTION # 123
......

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