Clinical Workflow
Stage-bound execution with independent validation and human review.
A staged clinical statistics workflow connecting approved inputs, repeatable execution, independent validation, and professional review.
Product Owner · Statistician · Systems Architect · Primary Builder
01 / The work problem
Specifications, programs, outputs, validation, and review can drift into separate tools and informal hand-offs, making state and accountability difficult to reconstruct.
02 / Workflow change
Each clinical stage begins with approved inputs and a defined scope, then moves through execution, independent validation, professional review, and a documented hand-off to the next stage.
03 / From input to review
Inputs, execution, validation, and review remain traceable.
- 01
Identify the working stage from the current Study state
- 02
Assemble the approved specification and relevant context
- 03
Run repeatable tasks and organize the stage results
- 04
Check source relationships, result structure, and execution records
- 05
Complete professional review and confirm the stage deliverable
04A / Professional judgment
Statisticians and reviewers own stage decisions, specifications, exception handling, scientific interpretation, and result approval.
04B / System support
The system turns approved specifications into repeatable tasks, organizes results and consistency checks, prepares review materials, and records relationships between stages.
05 / Verified evidence
Current capabilities verified against project sources.
- 01
The current foundation defines ten clinical statistics stages spanning Protocol, SAP, SDTM, ADaM, TFL, QC, and Submission, with action selection, review records, and knowledge-version references.
Source · clinical-workflow · PROJECT_SPEC.md - 02
The stages follow clinical-statistics business dependencies, with connected inputs, results, and review status.
Source · clinical-workflow · PROJECT_GUIDE.md - 03
Specifications, execution, result checks, and run records now share one traceable flow that is being exercised through representative clinical deliverables.
Source · clinical-workflow · PROJECT_SPEC.md - 04
Professional review decisions are retained with their context, processing record, and project state.
Source · clinical-workflow · PROJECT_SPEC.md
06 / Project status
Implemented capabilities and planned extensions.
Current
- Fixed clinical stages, action selection, structured review, knowledge-version references, and representative deliverable flows
Exploring
- Continuous run records, stage specifications, repeatable execution, independent validation, and stage-delivery management
Long-term
- A complete Study workflow connecting reviewed knowledge, statistical decisions, program execution, and quality review
07 / Workflow foundation
- Clinical stages and business dependencies
- Versioned specifications and run records
- Independent validation and professional review
- Traceable stage delivery
Workflow context
View complete workflow →