[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.56]

[Page 83-84]
 
                        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. 312.56  Review of ongoing investigations.

    (a) The sponsor shall monitor the progress of all clinical 
investigations being conducted under its IND.
    (b) A sponsor who discovers that an investigator is not complying 
with the signed agreement (Form FDA-1572), the

[[Page 84]]

general investigational plan, or the requirements of this part or other 
applicable parts shall promptly either secure compliance or discontinue 
shipments of the investigational new drug to the investigator and end 
the investigator's participation in the investigation. If the 
investigator's participation in the investigation is ended, the sponsor 
shall require that the investigator dispose of or return the 
investigational drug in accordance with the requirements of Sec. 312.59 
and shall notify FDA.
    (c) The sponsor shall review and evaluate the evidence relating to 
the safety and effectiveness of the drug as it is obtained from the 
investigator. The sponsors shall make such reports to FDA regarding 
information relevant to the safety of the drug as are required under 
Sec. 312.32. The sponsor shall make annual reports on the progress of 
the investigation in accordance with Sec. 312.33.
    (d) A sponsor who determines that its investigational drug presents 
an unreasonable and significant risk to subjects shall discontinue those 
investigations that present the risk, notify FDA, all institutional 
review boards, and all investigators who have at any time participated 
in the investigation of the discontinuance, assure the disposition of 
all stocks of the drug outstanding as required by Sec. 312.59, and 
furnish FDA with a full report of the sponsor's actions. The sponsor 
shall discontinue the investigation as soon as possible, and in no event 
later than 5 working days after making the determination that the 
investigation should be discontinued. Upon request, FDA will confer with 
a sponsor on the need to discontinue an investigation.

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 
FR 9586, Mar. 4, 2002]