Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi)
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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 2 — Unit 2.3.1 |
| Scope | HM |
| Document part | § 312.53
(c) (vi) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigator responsibilities, Protocol, Investigational drug (IMP), Amendment, FDA, Compliance |
Content
§ 312.53 Selecting investigators and monitors. […] (c) […] (vi) A commitment by the investigator that he or she: (a) Will conduct the study(ies) in accordance with the relevant, current protocol(s) and will only make changes in a protocol after notifying the sponsor, except when necessary to protect the safety, the rights, or welfare of subjects; (b) Will comply with all requirements regarding the obligations of clinical investigators and all other pertinent requirements in this part; (c) Will personally conduct or supervise the described investigation(s); (d) Will inform any potential subjects that the drugs are being used for investigational purposes and will ensure that the requirements relating to obtaining informed consent (21 CFR part 50) and institutional review board review and approval (21 CFR part 56) are met; (e) Will report to the sponsor adverse experiences that occur in the course of the investigation(s) in accordance with § 312.64; (f) Has read and understands the information in the investigator's brochure, including the potential risks and side effects of the drug; and (g) Will ensure that all associates, colleagues, and employees assisting in the conduct of the study(ies) are informed about their obligations in meeting the above commitments. […]
