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ACRP Certified Professional Exam Sample Questions (Q60-Q65):

NEW QUESTION # 60
When designing a clinical trial, why is it important to define the study population?

A. To determine the study objectives
B. To support the study objectives
C. To support subject recruitment to the study
D. To determine where to conduct the study

Answer: B

Explanation:
Defining the study population is crucial because it ensures that the trial targets the appropriate group for evaluating the investigational product (IP). A well-defined population supports the study objectives by providing reliable and interpretable data that can address the research questions.
GCP guidelines emphasize the need for a clearly defined study population to ensure the generalizability and accuracy of trial results.
"The study population must be clearly defined to ensure that the trial data are relevant and applicable to the intended patient group." Objectives:
* Enhance the scientific validity of clinical trial outcomes.
* Support the accurate interpretation of efficacy and safety data.

NEW QUESTION # 61
The process of ensuring and documenting that an electronic data processing system conforms to the sponsor's established requirements for completeness, accuracy, reliability, and consistent intended performance is called:

A. Quality Assurance
B. Validation
C. Quality Control
D. Programming

Answer: B

Explanation:
Validation is the process of ensuring that an electronic data processing system meets the sponsor's specifications for completeness, accuracy, reliability, and consistent performance. It involves systematic testing and documentation to demonstrate that the system functions as intended, especially in the context of capturing, processing, and managing clinical trial data.
GCP guidelines specify that validation of electronic systems is crucial to maintain data integrity and compliance with regulatory standards.
"Validation ensures that electronic data systems function according to the sponsor's requirements, maintaining data accuracy and reliability." Objectives:
Maintain data integrity and reliability.
Demonstrate system compliance with regulatory requirements.

NEW QUESTION # 62
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. In an emergency situation only, when this process is described in the protocol and has received permission from the ethics committee.
C. In an emergency situation only, even when this process is not described in the protocol, but the sponsor approves the consent process.
D. Only when the PI approves such a consent process, regardless of the emergency situation described in the protocol.

Answer: B

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 # 63
A clinical trial is conducted to measure the effectiveness of music therapy to reduce anxiety in intensive care unit patients. Patients are randomly assigned to receive headphones with music of their choice or headphones with white noise. The group receiving the white noise headphones is considered which type of control group?

A. Placebo
B. Active control
C. Alternate dose
D. No treatment

Answer: A

Explanation:
In this trial, the white noise group acts as a placebo control. While they are receiving an intervention (white noise), it is not the active therapeutic intervention (music therapy) being tested. Placebo controls help in assessing the effect of the active intervention by comparing it to a neutral or non-therapeutic alternative.
GCP guidelines state that a placebo control is a neutral intervention used to compare the effects of an active treatment.
"A placebo group is one that receives a neutral intervention, used to measure the efficacy of the active intervention by comparison." Objectives:
* Differentiate between active and placebo control groups.
* Evaluate therapeutic efficacy objectively.

NEW QUESTION # 64
A study protocol must contain which of the following elements?

A. Description of statistical methods
B. Data management plan
C. Participant reimbursement details
D. Chemical structure of the IP

Answer: A

Explanation:
A clinical study protocol must include a clear description of the statistical methods to be used in analyzing the collected data. This ensures that the analysis plan is predefined, unbiased, and statistically sound. The statistical methodology must address how the primary and secondary endpoints will be evaluated.
GCP guidelines require that the protocol clearly outlines statistical methods to ensure accurate and unbiased analysis of trial data.
"The protocol should include a detailed description of the statistical methods employed to ensure the validity of the trial results." Objectives:
* Maintain transparency in data analysis.
* Ensure scientific rigor in evaluating study outcomes.

NEW QUESTION # 65
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