[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.52]

[Page 82]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
        Subpart D--Responsibilities of Sponsors and Investigators
 
Sec. 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.