Study arms and assignments

Eligible participant → assignment approach → study arms → intervention or comparator

Flow diagram

Study arms and assignmentsStudy arms and assignmentsF1.S1Eligible study populationF1.S2Assignment approachF1.S3Study arm AF1.S4Study arm BF1.S5Intervention delivery planF1.S6Comparator delivery planF1.S7Common assessment planF1.N1Assignment and maskingArmStrategyAssignment ruleMaskingExceptionsArm AArm BF1.N2Assignment rationale

Steps

Eligible study population

Define eligibility and readiness for assignment.

Assignment approach

Specify randomized or nonrandomized assignment, stratification, concealment and ratio.

Study arm A

Describe assigned strategy; rename and add arms as needed.

Study arm B

Describe comparator strategy. Remove if the study has a single arm.

Intervention delivery plan

Specify dose, duration, adherence and permitted concomitant treatment.

Comparator delivery plan

Specify comparator delivery, adherence and permitted concomitant treatment.

Common assessment plan

Define arm-specific and shared assessment windows.

Tables and supporting information

Assignment and masking

Assignment and maskingArmStrategyAssignment ruleMaskingExceptionsArm AArm B

Add or remove arms; no allocation ratio is assumed.

Assignment rationale

Record the source and rationale for assignment and masking decisions.

Sources