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v1.3.0 — IND delivery alignment

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@mj3b mj3b released this 28 Dec 17:43
· 141 commits to main since this release
v1.3.0
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Learn about vigilant mode.

Overview

v1.3.0 aligns RGDS with real-world IND execution by making delivery and
regulatory decisions explicit, auditable, and phase-appropriate.

This release is grounded in observed IND program realities:
late-arriving data, complex dependencies, reviewer bottlenecks,
and the need to accept controlled risk without losing regulatory trust.

Highlights

  • IND-aware decision log schema extensions (optional, governance-controlled)
  • Explicit modeling of:
    • risk posture
    • author-at-risk drafting
    • reviewer triage
    • scope changes
    • dependency and data-readiness status
    • publishing lock points
  • Role → decision → artifact matrix covering PMs, writers, regulatory,
    CMC, ops, quality, and Principal AI Business Analysts
  • Updated governance and documentation
  • No agent autonomy; human accountability preserved

Intended audience

  • Principal AI Business Analysts
  • Program and delivery leaders in regulated environments
  • Regulatory, quality, and governance stakeholders

Compatibility

All existing RGDS examples remain valid and pass schema validation.

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