Endpoint map
Objectives → primary, secondary, exploratory and safety endpoints → assessment definitions
Flow diagram
Steps
Study objectives
State the clinical questions.
Primary endpoint
Define primary outcome, assessment and estimand. Duplicate for additional primary endpoints.
Secondary endpoint
Define key secondary or secondary outcomes and their roles.
Safety endpoint
Define safety outcome and observation window.
Primary success criteria
Specify whether all or any primary endpoints must meet criteria.
Secondary testing strategy
Specify ordering and conditions for confirmatory claims.
Safety assessment and monitoring
Specify review frequency and link to monitoring decisions.
Exploratory endpoints
Record hypothesis-generating endpoints separately from confirmatory claims.
Tables and supporting information
Endpoint register
Add one row per endpoint; document joint success rules separately.
Endpoint selection evidence
Record clinical relevance and measurement evidence.