[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.62]

[Page 77-78]
 
                        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. 312.62  Investigator recordkeeping and record retention.

    (a) Disposition of drug. An investigator is required to maintain 
adequate records of the disposition of the drug, including dates, 
quantity, and use by subjects. If the investigation is terminated, 
suspended, discontinued, or completed, the investigator shall return the 
unused supplies of the drug to the sponsor, or otherwise provide for 
disposition of the unused supplies of the drug under Sec. 312.59.
    (b) Case histories. An investigator is required to prepare and 
maintain adequate and accurate case histories that record all 
observations and other data pertinent to the investigation on each 
individual administered the investigational drug or employed as a 
control in the investigation. Case histories include the case report 
forms and supporting data including, for example, signed and dated 
consent forms and medical records including, for example,

[[Page 78]]

progress notes of the physician, the individual's hospital chart(s), and 
the nurses' notes. The case history for each individual shall document 
that informed consent was obtained prior to participation in the study.
    (c) Record retention. An investigator shall retain records required 
to be maintained under this part for a period of 2 years following the 
date a marketing application is approved for the drug for the indication 
for which it is being investigated; or, if no application is to be filed 
or if the application is not approved for such indication, until 2 years 
after the investigation is discontinued and FDA is notified.

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 61 
FR 57280, Nov. 5, 1996; 67 FR 9586, Mar. 4, 2002]