[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: 21CFR312.50]

[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. 312.50  General responsibilities of sponsors.


    Sponsors are responsibile for selecting qualified investigators, 
providing them with the information they need to conduct an 
investigation properly, ensuring proper monitoring of the 
investigation(s), ensuring that the investigation(s) is conducted in 
accordance with the general investigational plan and protocols contained 
in the IND, maintaining an effective IND with respect to the 
investigations, and ensuring that FDA and all participating 
investigators are promptly informed of significant new adverse effects 
or risks with respect to the drug. Additional specific responsibilities 
of sponsors are described elsewhere in this part.