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ACRP-CP Practice Questions

ACRP Certified Professional Exam

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Total Questions : 125

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Question # 31

A deferred consent can take place in which of the following situations?

Options:

A.  

Only when the PI approves such a consent process, regardless of the emergency situation described in the protocol.

B.  

In an emergency situation only, when this process is described in the protocol and has received permission from the ethics committee.

C.  

Only when the PI approves such a consent process immediately prior to patient enrollment, regardless of the situation being classed as emergency.

D.  

In an emergency situation only, even when this process is not described in the protocol, but the sponsor approves the consent process.

Discussion 0
Question # 32

In a quality management system, in which category do risk reduction activities belong?

Options:

A.  

Risk Evaluation

B.  

Risk Communication

C.  

Risk Review

D.  

Risk Control

Discussion 0
Question # 33

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?

Options:

A.  

Immediately unblind the entire trial to ensure patient safety.

B.  

Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.

C.  

Conduct an urgent protocol amendment to include specific monitoring for hepatotoxicity and submit to the IRB/IE

C.  

D.  

Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.

Discussion 0
Question # 34

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?

Options:

A.  

1.8 mg/dL

B.  

2.6 mg/dL

C.  

3.0 mg/dL

D.  

3.6 mg/dL

Discussion 0
Question # 35

Who ensures information regarding payments to subjects is documented in a written consent form?

Options:

A.  

Coordinator

B.  

IRB/IEC

C.  

PI

D.  

Sponsor

Discussion 0
Question # 36

A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

Options:

A.  

Yes, the PI has a sufficient patient population to take part in this study.

B.  

No, the PI does not have the resources to perform all protocol-required procedures.

C.  

Yes, the PI can perform other imaging scans instead of the PET scans.

D.  

No, the PI is taking part in too many ongoing studies to participate in this study.

Discussion 0
Question # 37

One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:

Options:

A.  

Recording the date and time each data element is entered onto the source document.

B.  

Comparing source document data to other data recorded in the same study time period.

C.  

Recording data on source documents at the time the data are collected during the conduct of the study.

D.  

Allowing real-time access for data review in the eCR

F.  

Discussion 0
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