The Study Design Organizer

Q1: Is the study primarily collecting or analyzing data from or about individual humans? YES

Q2: What is the primary mode of inquiry? QUANTITATIVE

Q3: Does the investigator assign one or more interventions? YES

Q4: Are there one or more control groups? YES

Q5: Does the participant act as his/her own control? NO

Q6: Is the unit of assignment a single human? YES

Your Study Design Is...

• Non-Clustered Interventional Study

Add additional descriptor here:

Statistical intent (superiority, non-inferiority, equivalence) 

Sequence generation (random, blocking, stratification, etc see spreadsheet)

Allocation method (central, sequentially numbered and identical, etc. see spreadsheet)

Are participants assigned to more than one intervention group (ie arm)? (yes = factorial, no=parallel group)

Blinding/Masking (of participant, investigator, outcomes assessor, statistician)

Control group type (active, placebo, sham, usual care, dose comparison, historical?)

Study phase (Phase 0, I, II, III, IV)