Simulation probability precision plan StatMedAnalysis | Verified 2026-11-04 Instructions: Save a copy, replace blanks, and retain the completed version with your analysis plan. Use synthetic examples or approved aggregate counts only; do not add patient identifiers. Record unresolved decisions rather than inventing answers. This worksheet documents decisions and does not provide clinical advice. Project/version: __________ Date: __________ Prepared by: __________ 1. DEFINE THE EXPERIMENT Aim and data-generating scenario: ____________________ Estimand, method and success criterion (for example interval coverage): ____ Seed strategy and independent replicate generation: ____________________ What counts as a failed replicate and how it is reported: ______________ Fixed replicate count or separately justified stopping rule: ____________ 2. PLAN PRECISION ON THE PROBABILITY SCALE Target Monte Carlo SE: ______ (0.005 means 0.5 percentage points) Conservative required replicates=ceil(0.25/targetSE^2): _________________ Planned compute time and storage: ____________________ This rule is for independent Bernoulli replicate indicators, not dependent MCMC draws. 3. RECORD COMPLETED RESULTS Attempted runs: ____ failed runs: ____ denominator used R: ____ Successes k: ____ probability k/R: ____ Plug-in MCSE=sqrt(p(1-p)/R): ____ 95% Wilson interval for simulation probability: ____________________ At k=0 or k=R, zero plug-in MCSE does not mean zero uncertainty. Explain exclusions, target shortfalls and how failure rates affect interpretation: ____ Simulation uncertainty is separate from uncertainty in an individual clinical estimate. Final review Arithmetic checked by/process: __________ Date: __________ Unresolved limitations and next action: ____________________ Guide: https://www.statmedanalysis.com/blog/monte-carlo-simulation-precision