Sample size and decision rules

Specify precision thresholds and stopping

Justify precision or the complete decision rule, including any multistage stopping. A nominal one-sample test does not account automatically for uncertainty or changes in a historical benchmark.

Flow diagram

Steps

Define information objective

Choose estimation precision or a justified benchmark comparison.

Specify success and decision criteria

Define outcome scale, hypotheses if used and testing direction.

Evaluate size or precision scenarios

Record effect, variability or event assumptions, attrition and follow-up.

Address multiple decisions

Specify endpoint families, repeated looks and error control where applicable.

Specify stopping rules if used

Prespecify safety, futility or efficacy review and decision authority.

Document verified calculation and rationale

Record method, software/version and supporting evidence.