These are illustrative RGDS decision records (v2.0.0 whitepaper-aligned) intended to show how the Decision Log schema is used in practice across common phase-gate scenarios in regulated delivery.
Each example represents a single, concrete decision with explicit ownership, evidence linkage, risk posture, and governance controls.
v2.0.0 alignment note
Examples include:
- mandatory
options_considered - evidence completeness per evidence item (
evidence.evidence_items[].completeness_state) - explicit
risk_postureand structured residual risk (risk_assessment.residual_risk_items) - structured AI assistance disclosure when
ai_assistance.used=true
The following examples are considered canonical because they collectively demonstrate the full RGDS operating model across common decision outcomes.
-
rgds-dec-0001.json— Canonical conditional_go
Go decision with explicit, owned conditions, governance approvals, and clearly bounded follow-up actions. -
rgds-dec-0002-no-go.json— Canonical no_go
Defensible refusal with documented rationale, risks, and a defined re-entry path. -
rgds-dec-0003-defer-required-evidence.json— Canonical defer / abstain
Decision deferred pending required evidence, with explicit gaps and re-review criteria. -
rgds-dec-0004-regulatory-interaction.json— Canonical regulatory interaction / escalation
Pre-IND or agency-facing decision framing, including questions, strategy, and governance rationale. -
rgds-dec-0005-ind-conditional-go-author-at-risk.json— Canonical IND-style conditional_go
IND readiness decision demonstrating author-at-risk drafting, reviewer triage, and publishing lock points. -
rgds-dec-0006-ai-assisted-conditional-go.json— Canonical AI-assisted conditional_go
Conditional-go decision demonstrating bounded AI assistance with explicit disclosure, preserved human authority, and full auditability.
rgds-dec-0006-ai-assisted-conditional-go.json is the only example in this
repository that demonstrates AI-assisted decision preparation.
All other examples are fully human-authored and remain valid demonstrations of the RGDS operating model without any AI involvement.
This is intentional: RGDS is designed to be AI-optional, and all decisions must remain defensible in the absence of AI assistance.