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ACRP Certified Professional Exam Sample Questions (Q66-Q71):

NEW QUESTION # 66
Who takes responsibility for initiating a clinical trial?

A. Sponsor
B. CRO
C. Investigator
D. IRB/IEC

Answer: A

Explanation:
The sponsor is responsible for initiating a clinical trial. This involves developing the protocol, securing funding, selecting study sites, and obtaining regulatory approvals. The sponsor also oversees the conduct of the trial to ensure compliance with GCP and regulatory requirements.
According to GCP guidelines, the sponsor is the entity that initiates, manages, and finances the clinical investigation.
"The sponsor is responsible for initiating, managing, and financing the clinical trial, including protocol development and site selection." Objectives:
* Understand the sponsor's role in trial initiation.
* Ensure compliance from the outset of the study.

NEW QUESTION # 67
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. Conduct an urgent protocol amendment to include specific monitoring for hepatotoxicity and submit to the IRB/IEC.
B. Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.
C. Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.
D. Immediately unblind the entire trial to ensure patient safety.

Answer: C

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 # 68
Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?

A. 3.0 mg/dL
B. 2.6 mg/dL
C. 1.8 mg/dL
D. 3.6 mg/dL

Answer: A

Explanation:
To calculate the maximum allowable creatinine level, multiply the upper limit of normal (1.2 mg/dL) by 2.5.
1.2 x 2.5 = 3.0 mg/dL
Therefore, the maximum creatinine level that a participant can have to remain eligible for the trial is 3.0 mg
/dL.
GCP guidelines specify that eligibility criteria, including lab values, must be strictly followed to maintain protocol compliance.
"The protocol specifies that laboratory values must not exceed the defined limits to ensure participant safety and data integrity." Objectives:
* Maintain accurate interpretation of laboratory criteria.
* Ensure compliance with protocol-defined inclusion/exclusion criteria.

NEW QUESTION # 69
A root cause analysis should be:

A. Focused on issues of non-compliance.
B. Written by the investigator.
C. Specific to a clinical trial.
D. Validated before use in a CAPA.

Answer: A

Explanation:
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.

NEW QUESTION # 70
In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?

A. CRC
B. Investigator
C. CRA
D. Sponsor

Answer: B

Explanation:
The Principal Investigator (PI) holds ultimate responsibility for ensuring that all study-related functions are conducted by qualified and trained personnel. The PI must verify that staff have the necessary qualifications and training to perform their assigned tasks as outlined in the protocol. This responsibility is crucial for maintaining compliance with GCP and ensuring data integrity.
According to GCP guidelines, the PI must ensure that all staff assisting with the trial are adequately trained and qualified for their roles.
"The investigator is responsible for ensuring that all persons assisting with the trial are qualified by education, training, and experience to perform their respective tasks." Objectives:
* Maintain compliance with GCP requirements.
* Ensure qualified personnel conduct study tasks.

NEW QUESTION # 71
......

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