Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (d)
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| Document information | |
|---|---|
| Reference | USA 21 CFR Part 312 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | HM |
| Document name | 21 CFR Part 312 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 21 —Food and Drugs
Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter D—Drugs for Human Use Part 312 Investigational New Drug Application https://www.ecfr.gov/current/title-21 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.2.7 |
| Scope | HM |
| Document part | § 312.23
(6) (d) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Study design, Protocol, Investigational drug (IMP), Requirements |
Content
§ 312.23 IND content and format. […] (6) Protocols. [...] (d) A description of the design of the study, including the kind of control group to be used, if any, and a description of methods to be used to minimize bias on the part of subjects, investigators, and analysts. [...]
