Code of Federal Regulations (21 CFR 312.23) clearly defines content and format for INDs. In addtion, FDA maintains guidance documents on the format and content of these applications to assist applicants in their preparation. The major outline of content and format for INDs is listed below:

1. Cover sheet (Form FDA-1571)
2. A table of contents
3. Introductory statement and general investigational plan (including the broad objectives and planned duration of the proposed clinical investigation)
4. [Reserved]
5. Investigator's brochure (drug substance and the formulation, pharmacological and toxicological effects, pharmacokinetics and biological disposition, information relating to safety and effectiveness, and possible risks and side effects)
6. Protocols (in general, protocols for Phase 1 studies may be less detailed and more flexible than protocols for Phase 2 and 3 studies)
7. Chemistry, manufacturing, and control (CMC) information (including the composition, manufacture, and control of the drug substance and the drug product)
8. Pharmacology and toxicology information (pharmacological and toxicological studies of the drug involving laboratory animals or in vitro, on the basis of which the sponsor has concluded that it is reasonably safe to conduct the proposed clinical investigations)
9. Previous human experience with the investigational drug (summary of previous human experience known to the applicant, either in the United States or other countries)
10. Additional information (e.g. Pediatric study plans for assessing pediatric safety and effectiveness)