#1
Which organization oversees the regulation of clinical trials in the United States?
Food and Drug Administration (FDA)
ExplanationFDA oversees the regulation of clinical trials in the United States.
#2
What is the primary purpose of regulatory oversight in clinical trials?
To protect the rights, safety, and well-being of study participants
ExplanationRegulatory oversight in clinical trials is primarily to protect the rights, safety, and well-being of study participants.
#3
Which regulatory agency oversees clinical trials in the European Union?
European Medicines Agency (EMA)
ExplanationEuropean Medicines Agency (EMA) oversees clinical trials in the European Union.
#4
Which phase of clinical trials involves testing the drug or treatment on a larger group of people to assess its efficacy, monitor side effects, and collect information for safe use?
Phase 3
ExplanationPhase 3 involves testing the drug or treatment on a larger group of people to assess its efficacy, monitor side effects, and collect information for safe use.
#5
What does the term 'informed consent' mean in the context of clinical trials?
Participants are informed about the potential risks and benefits of the trial and voluntarily agree to participate
ExplanationInformed consent means participants are informed about the potential risks and benefits of the trial and voluntarily agree to participate.
#6
What is the purpose of the Institutional Review Board (IRB) in clinical trials?
To ensure the safety and welfare of human participants in research studies
ExplanationThe purpose of the Institutional Review Board (IRB) in clinical trials is to ensure the safety and welfare of human participants in research studies.
#7
In which phase of clinical trials are the safety and efficacy of a drug tested on a small group of healthy volunteers?
Phase 1
ExplanationPhase 1 involves testing the safety and efficacy of a drug on a small group of healthy volunteers.
#8
What is the purpose of a placebo in a clinical trial?
To provide a baseline for comparison against the active treatment
ExplanationThe purpose of a placebo in a clinical trial is to provide a baseline for comparison against the active treatment.
#9
Which of the following is NOT a common reason for a clinical trial to be terminated prematurely?
Early achievement of desired outcomes
ExplanationEarly achievement of desired outcomes is NOT a common reason for a clinical trial to be terminated prematurely.
#10
What is the purpose of blinding in a clinical trial?
To prevent bias in the assessment of study outcomes
ExplanationBlinding in a clinical trial is done to prevent bias in the assessment of study outcomes.
#11
What is the purpose of the Declaration of Helsinki?
To ensure the ethical treatment of human subjects in medical research
ExplanationThe purpose of the Declaration of Helsinki is to ensure the ethical treatment of human subjects in medical research.