1. Study design. Examples: prospective randomized trial, cohort, case-controlled
2. Subjects identification (if clinical). Include inclusion and exclusion criteria, subject recruitment, and setting. If the subjects are divided into groups, identify the different groups.
3. Materials identification (if basic science). Include items needed for the research, such as reagents, tissue, and lab resources.
4. Intervention or test. Identify all the independent variables that will be collected and tested.
5. Outcomes measures. Clarify the outcome or dependent variable. This is the test variable that is central to the research question and hypothesis.
6. Sample size estimate.
7. Statistical test. State the statistical test that will be used. Why was the particular test chosen? What is being compared to what? The hypothesis statement should set the stage for the statistical test choice.