Study drug A versus Standard of care

Study drug A versus Placebo

Study drug A versus Standard of care

Select one of the studies.

PART 1: (10 points)

In your own words define:

The Null hypothesis (2.5 points)

The Alternative hypothesis (2.5 points)

For the study you have selected write the null and the alternative hypotheses (2.5 points)

For the study you have selected, explain if the investigator should use a one-sided or a two-sided statistical test and why? (2.5 points)

PART 2: (10 points)

Study drug A versus Standard of care

Explain in brief with examples, CRF and non-CRF data. (5 points)

There are majorly two ways of data capture: Paper CRFs (which is now getting rare) and electronic CRFs. Explain in detail the advantages and disadvantages of the two types. When you answer this, keep in mind how it would matter to the data entry personnel, the data manager and the principal investigator.