Protocol-to-SAP Handoff Kit
An editable crosswalk connecting protocol objectives and estimands to analysis specifications, diagnostics, outputs, owners, and deviations before programming.
On this page
What this is
A working handoff from a study protocol to its statistical analysis plan (SAP). Stable traceability IDs connect each research question with its target quantity, implementation record, analysis, and table or figure. The protocol and SAP remain separate controlled documents.
When to use
Use after defining the study question and while resolving the analysis specification, before programming or outcome-dependent choices. Start with the relevant protocol template. Route randomized trials, indirect comparisons, and economic analyses to the matching design-specific plan rather than applying observational assumptions to every study.
What it requires
For every objective, distinguish the estimand from the estimator and recorded variables. Specify population, treatment strategies, endpoint, time horizon, intercurrent events, effect scale, covariates, missingness, inference, diagnostics, and output IDs. Name the owner of unresolved decisions and retain the version and timing of any change.
When not to use
A filled crosswalk is not a complete SAP, a scientific approval, or proof that choices were prespecified. It does not choose the estimand, adjustment set, or censoring strategy. A sensitivity analysis that changes the target question must say so.
How it maps to the catalog
Pair with protocol templates, protocol and SAP elements, and the claims specification worksheet. HARPER and STaRT-RWE support reproducible specification; reporting checklists have a different role.
Downloads
Word template · Markdown · Build prompt · Review prompt
Model assistance
Complete kit ZIP · Instructions · Portable SKILL.md. Keep the folder together. Use the separate review prompt on the actual completed artifacts; the model must preserve missing facts and unapproved choices as unresolved.
Checklist
- Link every primary and key secondary objective to a stable traceability ID and governing protocol version.
- Specify the estimand separately from the estimator, observed fields, diagnostics, and output.
- Record unresolved choices, named owners, decision dates, and result-awareness in the change log.
- Attach the relevant design-specific analysis modules and implementation records before programming.
Citations
- [1]Wang SV, Pottegård A, Crown W, et al. HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: a good practices report of a joint ISPE/ISPOR task force. Pharmacoepidemiology and Drug Safety. 2023;32(1):44-55.
- [2]Wang SV, Pinheiro S, Hua W, et al. STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies. BMJ. 2021;372:m4856.