Business Meaning
- Turn protocol operations from ad-hoc tasks into a visible pipeline.
- Make every review decision traceable for QA and leadership reporting.
- Shorten time from protocol change to operational action plan.
Workflow MVP+
Give CTM teams one clear daily loop: decide, act, review, and publish evidence.
Start with these items in order. Complex analytics can stay mocked at this phase.
1) Ingest
queuedDocument intake is registered with owner and version tag.
Clinical Ops · SLA same day
2) Extract
queuedJSON fields + evidence spans generated (mock/LLM).
AI Engine · SLA 15 min
3) Review
queuedHuman accept/edit/reject decisions recorded in audit log.
Medical + Ops · SLA 24 h
4) Validate
queuedCritical structural and consistency checks completed.
Standards QA · SLA same day
5) Publish
queuedUSDM / DDF artifacts and handoff package are available.
Platform · SLA same day
6) Feedback
queuedAmendment signals are linked back to design objects.
CTM · SLA weekly cycle
No live study found. You can still demo the full flow with mock mode.