NAPSR Exam Chapter 11 with
100%Correct Answers
According to NIH ethical guidelines, which of the following is the most important criteria
in selecting subjects for clinical studies? - correct answer-scientific objectives
Which statement about the IRB is INCORRECT? - correct answer-The members of the
IRB/IEC must be experts in the topic of the study
Which phases of clinical studies are "open label" and which are blinded? - correct
answer-Phase I and IV trials are often open label, but Phase II and III are double
blinded or at least blinded
If it is not possible to measure the direct effects of a drug, what is used instead? -
correct answer-surrogate markers such as blood pressure and cholesterol levels
Which of the following is an observational study that first identifies a group of subjects
with a certain disease and a control group without the disease, and then looks to back in
time (e.g. via chart reviews) to find exposure to risk factors? - correct answer-case-
control study
Which measure of central tendency is the sum of all observations divided by the number
of observations? - correct answer-mean
Which measurement describes the number of new events that occur during a specified
period of time in a population at risk for the event (e.g., lung infections per year)? -
correct answer-incidence
Which of the following measures is used to describe the variability of the population
mean? - correct answer-standard error of the mean
Which of the following terms denotes the extent to which a test actually measures what
it is supposed to be measuring, or what we think it is measuring? - correct answer-
validity
What are the Kaplan-Meier analysis and Cox proportional hazards analysis? - correct
answer-methods of survival analysis
What section of a clinical paper describes subjects' entry and exclusion criteria? -
correct answer-methods
100%Correct Answers
According to NIH ethical guidelines, which of the following is the most important criteria
in selecting subjects for clinical studies? - correct answer-scientific objectives
Which statement about the IRB is INCORRECT? - correct answer-The members of the
IRB/IEC must be experts in the topic of the study
Which phases of clinical studies are "open label" and which are blinded? - correct
answer-Phase I and IV trials are often open label, but Phase II and III are double
blinded or at least blinded
If it is not possible to measure the direct effects of a drug, what is used instead? -
correct answer-surrogate markers such as blood pressure and cholesterol levels
Which of the following is an observational study that first identifies a group of subjects
with a certain disease and a control group without the disease, and then looks to back in
time (e.g. via chart reviews) to find exposure to risk factors? - correct answer-case-
control study
Which measure of central tendency is the sum of all observations divided by the number
of observations? - correct answer-mean
Which measurement describes the number of new events that occur during a specified
period of time in a population at risk for the event (e.g., lung infections per year)? -
correct answer-incidence
Which of the following measures is used to describe the variability of the population
mean? - correct answer-standard error of the mean
Which of the following terms denotes the extent to which a test actually measures what
it is supposed to be measuring, or what we think it is measuring? - correct answer-
validity
What are the Kaplan-Meier analysis and Cox proportional hazards analysis? - correct
answer-methods of survival analysis
What section of a clinical paper describes subjects' entry and exclusion criteria? -
correct answer-methods
