Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.52

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 2.2.1
Scope	HM
Document part	§ 312.52
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	CRO, Sponsor responsibilities, Sponsor, Written agreement

Content

§ 312.52 Transfer of obligations to a contract research organization. (a) A sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract research organization. Any such transfer shall be described in writing. If not all obligations are transferred, the writing is required to describe each of the obligations being assumed by the contract research organization. If all obligations are transferred, a general statement that all obligations have been transferred is acceptable. Any obligation not covered by the written description shall be deemed not to have been transferred. (b) A contract research organization that assumes any obligation of a sponsor shall comply with the specific regulations in this chapter applicable to this obligation and shall be subject to the same regulatory action as a sponsor for failure to comply with any obligation assumed under these regulations. Thus, all references to “sponsor” in this part apply to a contract research organization to the extent that it assumes one or more obligations of the sponsor.