[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR54.6]

[Page 299]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 54--FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS--Table of Contents
 
Sec. 54.6  Recordkeeping and record retention.

    (a) Financial records of clinical investigators to be retained. An 
applicant who has submitted a marketing application containing covered 
clinical studies shall keep on file certain information pertaining to 
the financial interests of clinical investigators who conducted studies 
on which the application relies and who are not full or part-time 
employees of the applicant, as follows:
    (1) Complete records showing any financial interest or arrangement 
as described in Sec. 54.4(a)(3)(i) paid to such clinical investigators 
by the sponsor of the covered study.
    (2) Complete records showing significant payments of other sorts, as 
described in Sec. 54.4(a)(3)(ii), made by the sponsor of the covered 
clinical study to the clinical investigator.
    (3) Complete records showing any financial interests held by 
clinical investigators as set forth in Sec. 54.4(a)(3)(iii) and 
(a)(3)(iv).
    (b) Requirements for maintenance of clinical investigators' 
financial records.
    (1) For any application submitted for a covered product, an 
applicant shall retain records as described in paragraph (a) of this 
section for 2 years after the date of approval of the application.
    (2) The person maintaining these records shall, upon request from 
any properly authorized officer or employee of FDA, at reasonable times, 
permit such officer or employee to have access to and copy and verify 
these records.