[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR54.6]
[Page 293-294]
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.
[[Page 294]]
(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.
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