CNPR - Chapter 11
According to NIH ethical guidelines, which of the following is the most important criteria in selecting
subjects for clinical studies? - Answer-scientific objectives
Which statement about the IRB is INCORRECT? - 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? - 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? - 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 risk factors? - Answer-case-control study
Which measure of central tendency is the sum of all observations divided by the number of
observations? - Answer-mean
According to NIH ethical guidelines, which of the following is the most important criteria in selecting
subjects for clinical studies? - Answer-scientific objectives
Which statement about the IRB is INCORRECT? - 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? - 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? - 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 risk factors? - Answer-case-control study
Which measure of central tendency is the sum of all observations divided by the number of
observations? - Answer-mean
