StochStack

prototype 13

CSR Drafting from BDS + TFL/RTF

Generate CSR draft blocks by separating data-independent and data-dependent sections from protocol synopsis, BDS, and TFL/RTF inputs.

Protocol Synopsis

BDS Summary

TFL/RTF Content

update log

Prototype Change Log

  1. 2026-03-01 · v0.3.0

    Data Anchoring and Consistency Validation Added

    • - Added numeric data-anchor extraction from CSR draft sections with anchor status (exact/approximate/missing).
    • - Added draft-vs-TFL numeric consistency checks with pass/warn/fail outputs.
    • - Added validation panel for unresolved anchors and section-level traceability completeness.

  2. 2026-03-01 · v0.2.0

    ICH E3 Assembly + TFL Traceability Added

    • - Added auto assembly for ICH E3 Sections 9-14.
    • - Added table/figure/listing placeholder list from parsed TFL references.
    • - Added section-level traceability linking CSR statements to TFL identifiers.

  3. 2026-03-01 · v0.1.0

    CSR Drafting Prototype Added

    • - Added workflow to generate CSR draft sections from protocol synopsis + BDS + TFL/RTF.
    • - Separated output into data-independent and data-dependent narrative blocks.
    • - Added JSON export for downstream medical writing and review workflows.