1. Draw up a protocol.

   • What are we trying to study? Will this study generate new knowledge on this topic?

   • Detailing the standards of the study, including the inclusion and exclusion criteria, sample size required, what treatments will be implemented, deciding the environment the study will be conducted in, how and when the results will be collected, will we implement blinding to further reduce bias?

2. Select the study population.

   • What is our reference or target population? Who will be affected with the outcome of the study?

   • Who will be included or excluded from the study population? Is it possible to randomly select from the target population?

   • Ensure informed consent is obtained if they are eligible.

3. Randomization.

   • Selected participants are randomly allocated into either the intervention groups or control group. This is the most important aspect of a RCT to reduce bias and generate confidence in the results.

4. Implement intervention or manipulation of variable.

   • The independent variable is implemented (i.e. drug, vaccine, procedure, health advice) as per original protocol.

5. Follow-up and data collection.

   • Examination of all participants at defined intervals under similar circumstances.

6. Assessment of outcomes.

   • Final assessment of the outcome and comparison of results between treatment groups and control group.

   • Through statistical analysis, is there a d ifference between the groups? A change in disease rates, symptoms, or mortality if the study has taken over several years?

(Aryal, 2022)