This is a ready-to-use completeness checklist for an initial Investigational New Drug (IND) application, mapped to the content requirements in 21 CFR 312.23. It is a pre-submission gate: work each item to Yes, N/A with rationale, or a documented gap before the application goes to the FDA. Replace every <<FILL: ...>> placeholder. A filled specimen follows.
Checklist control
| Field | Entry |
|---|---|
| Checklist number | <<FILL: CHK-ID>> |
| Product / candidate | <<FILL: candidate code, no confidential name>> |
| IND type | Commercial / Research / Expanded access / Emergency |
| Target submission date | <<FILL>> |
| Completed by | <<FILL>> |
Section 1: Administrative and forms
| # | Item | Ref | Status (Y / N / NA) | Evidence / location |
|---|---|---|---|---|
| 1.1 | Form FDA 1571 (cover sheet) complete and signed by the sponsor | 312.23(a)(1) | <<FILL>> | <<FILL>> |
| 1.2 | Form FDA 1572 (Statement of Investigator) for each clinical investigator | 312.23(a)(6), 312.53 | <<FILL>> | <<FILL>> |
| 1.3 | Table of contents and correct eCTD structure | 312.23(a)(2) | <<FILL>> | <<FILL>> |
| 1.4 | Introductory statement and general investigational plan for the coming year | 312.23(a)(3) | <<FILL>> | <<FILL>> |
Section 2: Investigator’s Brochure and protocol
| # | Item | Ref | Status | Evidence / location |
|---|---|---|---|---|
| 2.1 | Investigator’s Brochure per ICH E6, current and complete | 312.23(a)(5) | <<FILL>> | <<FILL>> |
| 2.2 | Reference safety information in the IB is defined and consistent | 312.23(a)(5) | <<FILL>> | <<FILL>> |
| 2.3 | Clinical protocol: objectives, design, population, dosing, endpoints | 312.23(a)(6) | <<FILL>> | <<FILL>> |
| 2.4 | Safety monitoring and explicit stopping rules stated | 312.23(a)(6) | <<FILL>> | <<FILL>> |
| 2.5 | IRB and informed-consent plans confirmed (Parts 56 and 50) | 312.23(a)(6), Part 50/56 | <<FILL>> | <<FILL>> |
| 2.6 | Statistical considerations described | 312.23(a)(6) | <<FILL>> | <<FILL>> |
Section 3: Chemistry, Manufacturing, and Controls (Module 3)
| # | Item | Ref | Status | Evidence / location |
|---|---|---|---|---|
| 3.1 | Drug substance: description, manufacture, control, characterization | 312.23(a)(7) | <<FILL>> | <<FILL>> |
| 3.2 | Drug product: composition, manufacture, control | 312.23(a)(7) | <<FILL>> | <<FILL>> |
| 3.3 | Specifications and analytical methods appropriate to phase | 312.23(a)(7) | <<FILL>> | <<FILL>> |
| 3.4 | Stability data covering the planned trial duration | 312.23(a)(7) | <<FILL>> | <<FILL>> |
| 3.5 | Labeling for investigational use (caution statement) | 312.23(a)(7), 312.6 | <<FILL>> | <<FILL>> |
| 3.6 | Environmental assessment or claim of categorical exclusion | 312.23(a)(7)(iv)(e) | <<FILL>> | <<FILL>> |
| 3.7 | (Biologic) comparability plan flagged where process may change | ICH Q5E | <<FILL>> | <<FILL>> |
Section 4: Pharmacology and toxicology (Module 4)
| # | Item | Ref | Status | Evidence / location |
|---|---|---|---|---|
| 4.1 | Pharmacology and mechanism of action summarized | 312.23(a)(8) | <<FILL>> | <<FILL>> |
| 4.2 | GLP-compliant toxicology to the route and duration supporting the planned dosing | 312.23(a)(8), Part 58 | <<FILL>> | <<FILL>> |
| 4.3 | Safety pharmacology and toxicokinetics as applicable | 312.23(a)(8), ICH S7/M3 | <<FILL>> | <<FILL>> |
| 4.4 | First-in-human dose justification (NOAEL to human-equivalent dose, safety factor) documented and internally consistent | 312.23(a)(8) | <<FILL>> | <<FILL>> |
| 4.5 | GLP compliance statement or explanation of non-compliance | Part 58 | <<FILL>> | <<FILL>> |
Section 5: Previous human experience and other
| # | Item | Ref | Status | Evidence / location |
|---|---|---|---|---|
| 5.1 | Previous human experience summarized (prior trials, foreign marketing) | 312.23(a)(9) | <<FILL>> | <<FILL>> |
| 5.2 | Any additional information (dependence, radioactive drugs) as applicable | 312.23(a)(10) | <<FILL>> | <<FILL>> |
| 5.3 | Pre-IND meeting held and agreements reflected in the submission | 312.47 | <<FILL>> | <<FILL>> |
Sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| Regulatory lead | <<FILL>> | ||
| CMC lead | <<FILL>> | ||
| Nonclinical lead | <<FILL>> | ||
| QA | <<FILL>> |
Filled specimen
Illustrative extract for a first-in-human commercial IND. Candidate and references are examples.
| # | Item | Status | Evidence / location |
|---|---|---|---|
| 1.1 | Form FDA 1571 signed | Y | m1/us/1571.pdf, signed 12 Jun 2026 |
| 4.2 | GLP 28-day repeat-dose tox in two species | Y | m4/tox, studies TX-101, TX-102, GLP-compliant |
| 4.4 | FIH dose justification: NOAEL 50 mg/kg, HED with 10x safety factor, start 3 levels below MRSD | Y | Introductory statement section 3; cross-checked to m4 |
| 3.4 | Stability: 6 months at 5 C and 25 C, covers 4-month trial | Y | m3/3.2.P.8, ongoing |
| 3.6 | Environmental: categorical exclusion claimed | Y | m1 environmental claim |
| 2.4 | Stopping rules at grade 2 or higher drug-related AE | Y | Protocol section 6.4 |
Item 4.4 is the one reviewers scrutinize hardest for a first-in-human IND: if the dose-justification arithmetic in the introductory statement does not tie to the Module 4 toxicology, expect an information request that puts the 30-day clock under pressure.
Common gaps this checklist prevents
- Dose-justification narrative that does not reconcile with the Module 4 NOAEL.
- Stability data that does not cover the full planned trial duration.
- Missing or unsigned Form 1572 for a named investigator.
- Toxicology route or duration that does not support the proposed dosing.
- Treating the 30-day period as an approval rather than a default-effective clock.
How to adapt this checklist
- Set the checklist number and candidate code in the control block.
- Add rows for modality-specific content (cell and gene therapy: vector, cell bank, potency; combination product: device-constituent and human factors).
- Point each evidence cell to the actual eCTD leaf location.
- Confirm the current regulation and ICH references before you rely on them; this is educational guidance, not regulatory advice.