Multi-arm Outcomes Analysis
A study of 240 adults in 3 treatment arms with patient-reported outcomes at 12 weeks needs a specified plan from the protocol, analysis code, an independent check and a write-up. In most cores that is three people and several weeks.
Teams need the plan stated before anything runs, the objections raised and answered up front, the analysis executed and independently re-derived, and a report a clinician can read and a reviewer can trace.
Done by hand, the plan lives in email, the code in one person's folder, the check is a second look at the same output, and the write-up is reconstructed weeks later.
Every number derived twice
An independent validation regenerates the analysis from the approved plan alone, in Python, without reading the analysis code, and reconciles the two before results are shown.
Plan approved before anything runs
The estimand, the plan, its deviations and the objection ledger are hashed and signed; execution refuses an unsigned plan.
41 practice rules applied
A statistical-practice rulebook with citations marks what blocks, what must be declared and what is advisory, including a declared multiplicity correction.
How it works
Extract the plan from the protocol: outcomes, covariates, the model, the handling of missing data and the multiplicity correction, each stated and named.
Review the objections and approve: an objection pass writes the ledger before plan review; open questions arrive as one question with two to four options and a recommendation.
Run and validate independently: the analysis executes in Python or R from the signed plan, and the validation re-derives every number from the plan alone.
Report with the record: Answer, Limits, What this means, Methods, study design, Missing data and Results tables, with an APA Word file, figures and a sealed reproducibility bundle, plus what the published literature says on the question.