Based on 21 CFR Part 312 · CDER/CBER Reviewer Standards · ICH E6(R3) GCP — updates in real time as you fill the Checklist
| Section | Total Items | Complete | In Progress | Not Started | Critical Gaps | Score % | RAG Status |
|---|
This preview includes Section 1 in full + previews of 8 more sections. Full version: 120+ items across 9 sections.
Section 1 — Administrative & Cover Sheet (15 items, fully unlocked)
Section 2 — Table of Contents (3 sample items shown)
Sections 3–9 — locked previews with item counts & descriptions
Cover page, legend, and phase applicability guide
FDAMap training program overview
Phase 1 — First-in-human safety & PK studies
Phase 2 — Dose ranging & initial efficacy
Phase 3 — Pivotal confirmatory trials
Status Legend: ☐ Not started · ◑ In progress · ✓ Complete · 🔒 Locked — full version
Score = # of items marked Complete ÷ total items × 100.
90–100% — Inspection Ready: Strong readiness posture.
70–89% — On Track: Good progress, no critical items outstanding.
50–69% — At Risk: Significant gaps — escalate to team lead.
0–49% — Critical / Do Not Submit: Multiple blocking gaps remain.
Items marked CRITICAL are the checklist items most frequently cited by FDA as grounds for a clinical hold. The full version flags all 42 of them.
See the cost breakdown below — a single hold can cost $50K–$500K+ per month in trial delays.
Who fills in what? (full version)
QA / RA: Sections 1, 2, 3, 8, 9
Clinical / Biostatistics: Section 5
CMC / Pharm Sci: Section 6
Toxicologist: Section 7
Medical Officer / PI: Section 4
📅 Get the full checklist for $149 — or Get it FREE when you book a 30-Minutes consultation for $299 on any regulatory or clinical trial issues.
Write to info@FDAMap.com if you need any of these services.