Trial flow and follow-up reconciliation worksheet
StatMedAnalysis | Version 2026-10-31

Purpose: Complete a separate copy for each outcome and time point. Use aggregate counts only. Arithmetic balance does not validate the analysis population.

Instructions: Save a working copy, fill each prompt, and retain source locations. Use NOT REPORTED, NOT APPLICABLE or UNRESOLVED rather than an ambiguous blank. Do not enter patient identifiers. This worksheet is an original planning aid, not a validated instrument.

1. Protocol, analysis-plan version and selected outcome/time
Response: ______________________________

2. Screened count and source
Response: ______________________________

3. Pre-randomization exclusions with mutually exclusive primary reasons
Response: ______________________________

4. Randomized total and allocation counts by group
Response: ______________________________

5. Received versus did not receive assigned intervention in each allocated group
Response: ______________________________

6. Follow-up completion, missing follow-up and reasons by group
Response: ______________________________

7. Analyzed versus not analyzed for this outcome, both starting from allocation
Response: ______________________________

8. Reason categories: overlap check and rules for primary reason
Response: ______________________________

9. Intercurrent events versus missing data: record separately
Response: ______________________________

10. Reconciliation gaps and source-record corrections
Response: ______________________________

11. Planned analysis population and deviations; do not silently remove people
Response: ______________________________

12. Independent review, date, open issues and approval of final counts
Response: ______________________________

Next action / owner / due date: ______________________________