RGDS v1.2.0 — Explicit Risk Posture & Defensible Conditional Decisions
RGDS v1.2.0 strengthens decision defensibility in regulated, phase-gated workflows by making previously implicit judgment calls explicit, auditable, and condition-bound.
This release is grounded in real IND execution challenges surfaced by Syner-G practitioners and focuses on surgical schema additions rather than system redesign.
What’s new
- Explicit risk_posture
- Forces phase-appropriate risk tolerance and trade-off rationale to be stated, not implied.
- author_at_risk_items[]
- Formalizes placeholder drafting as a governed, owned risk with verification criteria and fallback.
- review_plan
- Captures reviewer triage decisions (required vs optional) under time pressure.
- scope_change_events[]
- Makes scope volatility and late discoveries auditable decision inputs.
- regulatory_interaction_decision
- Treats pre-IND and FDA interaction strategy as a first-class decision artifact.
- Required fallback_plan for conditional_go
- Ensures contingency planning is explicit before proceeding under uncertainty.
Canonical examples
- Conditional GO with author-at-risk drafting (execution / dependency management)
- GO with pre-IND regulatory interaction strategy (risk posture / FDA alignment)
What this is (and is not)
- ✅ Human-governed decision support
- ✅ Evidence-linked and schema-validated
- ✅ Designed for auditability and regulatory credibility
- ❌ Not an autonomous or agentic system
Compatibility
- Backward-compatible with v1.1 examples (additive schema changes only).
- All examples validated against updated schema.
Why this matters
RGDS v1.2.0 closes the gap between real execution decisions and what is typically left undocumented — scope trade-offs, reviewer routing, placeholder risk, and regulatory posture — without introducing automation risk or process overhead.
This release reinforces RGDS’s core purpose:
delivery → governance → decision confidence.