Adaptive design decision plan
Planned looks → adaptation criteria → permissible changes → subsequent analysis
Flow diagram
Steps
Planned adaptation opportunities
Define timing, information maturity and data access.
Decision inputs and operating characteristics
Specify inputs and verify design behavior across simulation scenarios.
Apply prespecified adaptation criteria
Define the allowed decision set and who has authority.
Continue unchanged
Record rationale and next planned look.
Apply permitted adaptation
Specify allowed changes to sample size, arms or allocation without inventing a default adaptation.
Stop or close a component
Specify follow-up and final inference after stopping.
Final inference and decision record
Account for adaptation in estimation, testing and reporting.
Tables and supporting information
Simulation and operating characteristics
Enter externally verified simulation results and software versions.
Permitted adaptation rules
Do not infer authorization or a validated design from a drawn branch.
Simulation and design evidence
Attach method, simulation configuration and independent verification.
Operational safeguards
Specify confidentiality, review independence and implementation controls.