Interim monitoring and stopping
Information schedule → efficacy, futility or safety review → continue, modify or stop decision
Flow diagram
Steps
Monitoring and information schedule
Specify review timing, data maturity and authorized access.
Review accumulated information
Define independent review roles and blinded/unblinded access.
Efficacy assessment
Specify efficacy criterion and information basis.
Futility assessment
Specify predictive or conditional criteria and binding status if relevant.
Safety assessment
Specify events, exposure and risk review criteria.
Authorized monitoring decision
Apply prespecified rules with documented review rationale.
Continue to next planned review
Record continuation and next information point.
Permitted modification
Record authorized changes and their impact on inference.
Stop and transition to closure
Record stopping reason, follow-up obligations and final analysis implications.
Tables and supporting information
Monitoring boundaries and actions
Boundary cells remain blank; link to reviewed method or simulation evidence.
Review charter and evidence
Record charter, independence arrangements and method references.
Repeated review and final inference
Specify subsequent review schedule and control of repeated analysis opportunities.