Secondary Data Reporting Handoff Checklist ========================================= StatMedAnalysis | Original checklist | 6 November 2026 Purpose Use this checklist when an analysis of existing observational data moves from the analysis team to manuscript drafting. It checks whether a reader can trace the reported question, cohort and results. It is not STROBE, RECORD, an official reporting guideline, a quality score or approval of the study design. Instructions Save a working copy. For each item record PASS, ACTION NEEDED or NOT APPLICABLE with a reason, then name the exact evidence location. Do not award points or add items into a quality score. Complete the applicable official reporting guideline separately. Use only public, hypothetical or aggregate information in this file. Retain patient records and confidential evidence in the approved environment. Manuscript/version: __________________ Analysis freeze: __________________ Prepared by role/date: _______________ Independent check: _________________ QUESTION AND DESIGN 1. Can the intended target quantity be stated without relying on a model name? Status / evidence / action: ________________________________________________ 2. Are causal, associational, descriptive or predictive aims distinguished? Status / evidence / action: ________________________________________________ 3. Are the source population, target population and calendar period explicit? Status / evidence / action: ________________________________________________ 4. Do eligibility, exposure assignment and follow-up start use compatible timing? Status / evidence / action: ________________________________________________ 5. Are data-source access conditions and relevant approvals accurately described? Status / evidence / action: ________________________________________________ COHORT AND MEASUREMENT 6. Can every cohort exclusion be traced to a reproducible rule and aggregate count? Status / evidence / action: ________________________________________________ 7. Are entity linkage, duplicate resolution and any validation limits explained? Status / evidence / action: ________________________________________________ 8. Are exposure and outcome code lists, thresholds and assessment windows defined? Status / evidence / action: ________________________________________________ 9. Are recorded proxies distinguished from the clinical constructs they represent? Status / evidence / action: ________________________________________________ 10. Are changes in instruments, coding systems or data capture addressed? Status / evidence / action: ________________________________________________ 11. Are eligible, observed and missing denominators reconciled for each analysis? Status / evidence / action: ________________________________________________ 12. Are censoring and competing events described in relation to the target quantity? Status / evidence / action: ________________________________________________ ANALYSIS AND RESULTS 13. Is the adjustment set justified by variable roles and measurement timing? Status / evidence / action: ________________________________________________ 14. Are the model/estimator, coding, functional forms and contrast reproducible? Status / evidence / action: ________________________________________________ 15. Are dependence, uncertainty methods and sparse-data limitations addressed? Status / evidence / action: ________________________________________________ 16. Are missing-data and loss-to-follow-up assumptions named and examined? Status / evidence / action: ________________________________________________ 17. Are model diagnostics and material failures reported without claiming certainty? Status / evidence / action: ________________________________________________ 18. Are planned analyses, later changes and exploratory results distinguishable? Status / evidence / action: ________________________________________________ 19. Do tables state population, units, reference groups, time windows and intervals? Status / evidence / action: ________________________________________________ 20. Do sensitivity analyses identify which assumptions or questions they change? Status / evidence / action: ________________________________________________ CLAIMS AND RELEASE 21. Does the abstract use the same frozen counts and estimates as the main results? Status / evidence / action: ________________________________________________ 22. Does interpretation acknowledge residual confounding, measurement and selection? Status / evidence / action: ________________________________________________ 23. Are target-population limits, uncertainty and clinically meaningful values clear? Status / evidence / action: ________________________________________________ 24. Are data/code access statements accurate and consistent with permissions? Status / evidence / action: ________________________________________________ 25. Are software versions, contributor roles, funding and conflicts documented? Status / evidence / action: ________________________________________________ 26. Has a reviewer traced each main claim to its source output and recorded gaps? Status / evidence / action: ________________________________________________ Hypothetical worked case A fictional manuscript reports 420 participants in its abstract but 408 in the primary analysis table. Item 21 is ACTION NEEDED. The team traces the difference to 12 observations lacking the required outcome. It corrects the abstract or clarifies enrolled versus analyzed counts as appropriate, documents missingness, and checks every dependent percentage. Matching counts alone would not validate the missing-data assumptions. Decision rule Do not treat all PASS entries as proof of validity. Resolve material gaps that prevent readers from identifying the cohort, reproducing the analysis or judging the claims. Keep justified limitations visible in the manuscript and record remaining actions before submission. A NOT APPLICABLE response needs a reason. Open material issues: ______________________________________________________ Action / owner / due date: _________________________________________________ Handoff decision and scope: ________________________________________________ Primary guidance checked 6 November 2026 STROBE official checklists: https://www.strobe-statement.org/checklists/ RECORD statement (original publication): https://pmc.ncbi.nlm.nih.gov/articles/PMC4595218/ ICMJE recommendations: https://www.icmje.org/recommendations/ These sources inform the questions above. This original operational checklist does not reproduce or replace their official checklist items.