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ACRP Certified Professional Exam Sample Questions (Q46-Q51):
NEW QUESTION # 46
What is a systematic and independent examination of trial-related activities and documents todetermine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsors, SOPs, GCP, and the applicable regulatory requirements?
Answer: A
Explanation:
An audit is a systematic and independent examination of trial-related activities and documents. Its purpose is to determine whether the study was conducted in compliance with the protocol, GCP, and regulatory requirements. Audits are usually performed by the sponsor or an independent auditor and focus on evaluating data integrity and trial conduct.
GCP guidelines define an audit as a thorough examination to ensure adherence to protocol and regulatory requirements.
"An audit is a systematic and independent examination of trial-related activities to verify compliance with the protocol and regulatory standards." Objectives:
Ensure compliance and data integrity.
Identify any gaps in trial conduct.
NEW QUESTION # 47
The primary purpose for IRB/IEC approval of posters, fliers, social media posts, and promotional items is to:
Answer: B
Explanation:
The IRB/IEC's primary responsibility when reviewing recruitment materials such as posters, fliers, social media posts, and promotional items is to ensure that these materials safeguard the rights, safety, and well- being of potential participants. This includes ensuring that the information is presented ethically, clearly, and without coercion, maintaining compliance with ethical guidelines.
GCP guidelines require that any materials used for recruitment be reviewed to ensure they do not mislead participants and that they respect their rights and well-being.
"IRB/IEC review of recruitment materials ensures that they protect participants' rights and well-being and that the content is ethically appropriate." Objectives:
* Maintain ethical standards in recruitment.
* Protect potential participants from misleading or coercive information.
NEW QUESTION # 48
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?
Answer: D
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 # 49
Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?
Answer: A
Explanation:
Risk-based audits of CRO activities as delegated are considered the most efficient way of overseeing a CRO's management. This approach focuses on evaluating the critical risks that might impact data integrity and participant safety. It allows sponsors to allocate resources to areas with the highest potential for error or deviation, rather than performing exhaustive monitoring of all activities.
The answer is verified as per guidelines on risk-based monitoring strategies, emphasizing targeted and efficient oversight of CRO functions.
"Risk-based monitoring emphasizes focusing on critical study parameters and the risks that have the potential to affect data quality and subject safety." Objectives:
* Efficient management of outsourced clinical trial tasks.
* Ensuring data integrity through targeted audits.
NEW QUESTION # 50
The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?
Answer: C
Explanation:
When the IRB/IEC decides not to approve a clinical trial, they must notify the Principal Investigator (PI) in writing. This communication ensures that the PI is formally informed of the decision and cantake appropriate actions, such as revising the protocol or addressing the reasons for disapproval.
According to GCP guidelines, the IRB/IEC must communicate any decision regarding the approval status of a study directly to the PI, as the PI is responsible for the conduct of the trial.
"The IRB/IEC should promptly notify the investigator in writing of its decision to approve or disapprove the proposed research activity." Objectives:
* Maintain clear communication between the IRB/IEC and the investigator.
* Ensure timely notification of decisions affecting the study.
NEW QUESTION # 51
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