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Changelog

All notable changes to the RGDS framework and this study are documented here.

[1.4] — 2026-01-09

Documentation

  • Final ten-question study published to GitHub Pages via MkDocs Material
  • Bibliography confirmed at 96 entries with full source verification
  • Appendix A financial methodology documented with Tier 1 / Tier 2 citation structure
  • Methods and Technical Notes page added with full AI disclosure and validation procedures
  • Results Overview synthesized across all ten questions with confidence-stratified ROI table

Framework

  • Non-agentic AI governance principle articulated as a core design constraint
  • aiassistance object documented for FDA 7-step credibility framework alignment (Q9)
  • Regulatory trajectory framing finalized: Phase 1 (2026–27) voluntary, Phase 2 (2027–28) anticipated mandate (Q10)

[1.3] — 2025-12-20

Research

  • Q7 ROI model revised to three-tier confidence structure: operational (high), regulatory (medium), financial (excluded)
  • Q8 implementation roadmap extended to 24-month phased structure with explicit pilot validation gates
  • Cross-functional alignment analysis added to Q6 (baseline cycle time lost to misaligned assumptions: 4–6 weeks)

Schema

  • Decision log schema decision-log.schema.json drafted with semantic invariants
  • Example logs RGDS-DEC-0001 through RGDS-DEC-0006 produced covering Data Readiness Gates, Risk Assessment, Manufacturing Strategy, and Study Go/No-Go decisions
  • GitHub Actions CI/CD validation pipeline implemented

[1.2] — 2025-12-01

Research

  • Q4 FDA deficiency prevention analysis sharpened: 25–30% of CRLs are reconstructability-driven; realistic reduction of 12–25% total deficiency rate
  • Q5 decision cycle time baseline established: 45–90 days; RGDS target 20–35 days
  • Q9 AI governance disclosure structured against FDA January 2025 draft guidance seven-step framework

[1.1] — 2025-11-20

Research

  • Q1 reconstructability crisis framing established: 50% FDA CRL "insufficient information" finding as primary motivating statistic
  • Q2 AI accountability framework outlined: aiassistance object prototype
  • Q3 integration analysis begun: RACI, CPM, TPP, tiered QA, status meetings mapped to decision log consolidation

Infrastructure

  • MkDocs site structure initialized
  • Bibliography building begun via Perplexity AI deep research, verified against primary sources

[1.0] — 2025-11-01

Project initiation. Independent study scope defined: ten research questions spanning reconstructability, AI accountability, FDA compliance, ROI, and regulatory trajectory in biopharma/biotech phase-gated development. Research period: November 2025 – January 2026.