Analysis execution

Dataset version → analysis population → specified method → diagnostics → estimates → interpretation

Flow diagram

Analysis executionAnalysis executionF1.S1Analysis plan and datasetversionsF1.S2Derive the analysis populationF1.S3Execute specified analysisF1.S4Assess diagnostics anddeviationsF1.S5Estimate effects and uncertaintyF1.S6Independent review andinterpretationF1.N1Analysis resultsEndpointPopulationEstimateIntervalTestresultMethodSourceEndpointF1.N2Plan and analysis provenanceF1.N3Departures from the plan

Steps

Analysis plan and dataset versions

Record the prespecified plan, amendments, dataset and cutoff.

Derive the analysis population

Apply population rules and document exclusions.

Execute specified analysis

Record method, code, software version, seed if applicable and execution context.

Assess diagnostics and deviations

Compare diagnostics to the plan; record departures and remediation.

Estimate effects and uncertainty

Produce estimates, intervals and tests consistent with the estimand.

Independent review and interpretation

Verify outputs and interpret with limitations and protocol deviations.

Tables and supporting information

Analysis results

Analysis resultsEndpointPopulationEstimateIntervalTestresultMethodSourceEndpoint

Enter completed outputs from the analysis source; missing values are not zero.

Plan and analysis provenance

Link the approved plan, data/code versions and execution record.

Departures from the plan

Document what changed, when, why and whether the change was prespecified.

Sources