Initial research question

• the first step of study creation
• hypothesis
• requires detailed knowledge and careful consideration of implications
• needs to be clear

Choosing a study design

• needs to answer the research question
• outline the desired output from the study (plots and figures)

development and importance of a study protocol

• “algorithm” for study
• states primary and secondary hypothesis (problem statement)

statement of design

• what will the study test?
• description of study participants
• exposure, strategy, intervention or treatment and endpoints

Study sample