NAPSRX__Quiz_Chapter_11

According to NIH ethical guidelines, which of the following is the most important criteria in selecting subjects for clinical studies? Which statement about the IRB is INCORRECT? Which phases of clinical studies are “open label” and which are blinded? If it is not possible to measure the direct effects of a drug, what is used instead? 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? Which measure of central tendency is the sum of all observations divided by the number of observations? 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)? Which of the following measures is used to describe the variability of the population 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? What are the Kaplan-Meier analysis and Cox proportional hazards analysis? What section of a clinical paper describes subjects’ entry and exclusion criteria? Which document sets out how a trial is to be conducted (i.e., the study’s general design and operating features)? When designing and performing clinical trials, several ethical constraints must be considered. Which of the following is NOT one of these ethical constraints?