业务意义
- 把协议运营从零散任务变成可见的流水线。
- 让每次审阅决策都可追溯,便于 QA 与管理层复盘。
- 缩短从 protocol 变更到运营动作落地的时间。
Workflow MVP+
给 CTM 团队一个清晰的日常闭环:决策、执行、审阅、发布证据。
按顺序推进即可。当前阶段复杂分析可以先用 mock 支撑演示。
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
当前未发现 live study,你仍可用 mock 模式完整演示流程。