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 |
|---|
Go to the ✅ Checklist tab — your main working sheet with all 128 items pre-loaded across 9 sections, each with Regulatory Cite and Critical? columns.
Update the Status column — choose from the dropdown: Not Started → In Progress → Complete → N/A. Every change auto-updates the Dashboard.
Fill in Owner — assign each item to the responsible team member by name or initials.
Set Due Dates — enter target completion dates. Build backward from your submission date.
Add Notes — log document references, SOP numbers, file paths, or blockers in the Notes column.
Monitor the 📊 Dashboard tab — your readiness % and all 9 section scores update in real time. Check it in every team meeting.
Score = # of items marked Complete ÷ total items × 100. Critical items are flagged separately.
90–100% — Inspection Ready: Strong readiness posture. Review remaining gaps and confirm evidence is on file before submission.
70–89% — On Track: Good progress. Confirm 'In Progress' items have firm due dates and owners. No outstanding critical items should remain.
50–69% — At Risk: Significant gaps. Escalate to team lead. Request a Pre-IND meeting with FDA if key sections are incomplete.
0–49% — Critical / Do Not Submit: Multiple blocking gaps. Do not submit until all critical items are resolved. Seek qualified regulatory counsel immediately.
Items marked CRITICAL (red rows) are the checklist items most frequently cited by FDA as grounds for a clinical hold or outright rejection. Missing even one can block your IND.
There are 42 critical items across 9 sections. The Dashboard shows how many remain incomplete in real time.
You can mark a CRITICAL item N/A if genuinely not applicable — but you must document a clear justification in the Notes column. FDA may ask during review.
Who fills in what?
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
All: Final review before submission
Weekly review cadence: 30-minute weekly team sync to walk through the Dashboard. Flag items at risk of missing due dates. Red section scores = escalate immediately.
Submission countdown: Enter your target submission date in the Dashboard. The tracker automatically calculates days and weeks remaining.
Training Programs:
IND Application Preparation Workshop · Pre-IND Meeting Strategy · CMC for Early-Phase Trials · Clinical Hold Prevention & Response · GCP & ICH E6(R3) · FDA Drug Development Regulatory Pathway · Sponsor-Investigator IND Obligations
📅 Book a free 30-minute regulatory consultation at fdamap.com and receive the full IND Checklist document at no charge.