ALLOCATION COUNT PLANNING WORKSHEET StatMedAnalysis | 1 November 2026 Purpose: Translate an approved ratio into feasible arm counts; this sheet does not randomize participants. Instructions: Save a working copy. Complete each prompt using aggregate summaries or design decisions. Do not include patient identifiers, actual allocation sequences, or confidential records. Write NOT REPORTED, NOT APPLICABLE (with reason), or UNRESOLVED instead of silently leaving a field blank. Resolve flagged issues before using outputs in a report. This is an original planning aid, not a validated instrument or approval certificate. 1. Study design, arms and approved sample-size rationale: Response: __________________________________________________________ Evidence/action: ___________________________________________________ 2. Minimum total target and whether it already includes loss allowance: Response: __________________________________________________________ Evidence/action: ___________________________________________________ 3. Intended arm A:arm B ratio and clinical/operational rationale: Response: __________________________________________________________ Evidence/action: ___________________________________________________ 4. Reduced integer ratio and smallest whole ratio unit: Response: __________________________________________________________ Evidence/action: ___________________________________________________ 5. Rounded total, per-arm counts and extra participants above minimum: Response: __________________________________________________________ Evidence/action: ___________________________________________________ 6. Strata and whether allocation is managed separately within each: Response: __________________________________________________________ Evidence/action: ___________________________________________________ 7. Block-size policy and unpredictability assessment by authorized statistician: Response: __________________________________________________________ Evidence/action: ___________________________________________________ 8. Sequence generation method, software/version and independent validation: Response: __________________________________________________________ Evidence/action: ___________________________________________________ 9. Access restrictions: who generates, enrolls, assigns and audits? Response: __________________________________________________________ Evidence/action: ___________________________________________________ 10. Concealment mechanism; do not put the actual allocation sequence here: Response: __________________________________________________________ Evidence/action: ___________________________________________________ 11. Deviations, incomplete blocks and reporting plan: Response: __________________________________________________________ Evidence/action: ___________________________________________________ 12. Protocol version, source, approval/check roles and dates: Response: __________________________________________________________ Evidence/action: ___________________________________________________ Related guide and tool: https://www.statmedanalysis.com/resources Keep the completed copy in your approved research workspace.