Phase 4 — Biostats and TLF
Close the loop with statistical analysis planning and table/listing/figure generation. Highest-stakes work — gated on a double-programming sign-off.
| Workstream | Status | Shipped |
|---|---|---|
Biostats SAP authoring agents/22-sap-drafting drafts the Statistical Analysis Plan with cited references back to the protocol, ICH E9, and CDISC standards. Agents: 22-sap-drafting | planned | — |
TLF generation with double-programming gate agents/23-tlf-primary and agents/24-tlf-validator produce two independently programmed copies. Promotion to live requires a numeric-equality gate plus a human signature — the double-programming gate. Agents: 23-tlf-primary, 24-tlf-validator | planned | — |