Exempt research under the code of federal regulations

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Reference no: EM132264558

1. Which of the following would likely qualify as exempt research under the Code of Federal Regulations?

Study of a new indication for a drug already approved by the FDA

Survey of 16 year-olds about drug use

Hospital chart review of de-identified patient records

The study of a newly developed topical cream for the treatment of Eczema

2. Which of the following statements about p-values is true?

p-values help with random error but not systematic error

Variance plays no role in calculating p-values

A p of 0.001 is more clinically meaningful than a p of 0.05

p-values are not influenced by the number of observations

3. What term describes randomization of subjects based upon known potential confounding variables to ensure equal numbers of such cases in both experimental and control groups?

Computerized

Block

Stratified

Concealed

4. What is the best way to report the outcome of a dichotomous measure?

Mean (SE)

Median (IQR)

Relative frequencies

Effect size

5. Which of the following procedures adjusts the p value by dividing it by the number of comparisons to avoid p value inflation?

Wilcoxon

Bonferroni

Hotelling

Rasch

6. What phase of clinical research gathers long-term safety data?

Phase I

Phase II

Phase III

Phase IV

7. An investigator studying condom use in college students collects data at the university's health fair. She asks every third student who comes to her booth to complete an exit survey and mail it back in a previously stamped envelope. What form of bias may have occurred?

Instrument

Selection

Observer

Maturation

8. What may occur if an investigator performs a prospective double blinded study comparing a new inhaled medication with placebo for asthma in Bolivian coal miners?

Internal validity threat

External validity threat

No threat

9. Which of the following requires post-hoc testing?

Significant paired t-test

Simple Linear regression

Significant ANOVA

Chi-square table

10. An investigator sets her alpha level at p<.05.

If her results are significant and she rejects the null hypothesis, when the null hypothesis was in fact true. What has happened?

She used the wrong statistical test

She should have set her p value to 0.10

She made a Type I error

She made a Type II error

Reference no: EM132264558

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