[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: 21CFR54.2]

[Page 296-297]
 
                        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. 54.2  Definitions.

    For the purposes of this part:
    (a) Compensation affected by the outcome of clinical studies means 
compensation that could be higher for a favorable outcome than for an 
unfavorable outcome, such as compensation that is explicitly greater for 
a favorable result or compensation to the investigator in the form of an 
equity interest in the sponsor of a covered study or in the

[[Page 297]]

form of compensation tied to sales of the product, such as a royalty 
interest.
    (b) Significant equity interest in the sponsor of a covered study 
means any ownership interest, stock options, or other financial interest 
whose value cannot be readily determined through reference to public 
prices (generally, interests in a nonpublicly traded corporation), or 
any equity interest in a publicly traded corporation that exceeds 
$50,000 during the time the clinical investigator is carrying out the 
study and for 1 year following completion of the study.
    (c) Proprietary interest in the tested product means property or 
other financial interest in the product including, but not limited to, a 
patent, trademark, copyright or licensing agreement.
    (d) Clinical investigator means only a listed or identified 
investigator or subinvestigator who is directly involved in the 
treatment or evaluation of research subjects. The term also includes the 
spouse and each dependent child of the investigator.
    (e) Covered clinical study means any study of a drug or device in 
humans submitted in a marketing application or reclassification petition 
subject to this part that the applicant or FDA relies on to establish 
that the product is effective (including studies that show equivalence 
to an effective product) or any study in which a single investigator 
makes a significant contribution to the demonstration of safety. This 
would, in general, not include phase l tolerance studies or 
pharmacokinetic studies, most clinical pharmacology studies (unless they 
are critical to an efficacy determination), large open safety studies 
conducted at multiple sites, treatment protocols, and parallel track 
protocols. An applicant may consult with FDA as to which clinical 
studies constitute ``covered clinical studies'' for purposes of 
complying with financial disclosure requirements.
    (f) Significant payments of other sorts means payments made by the 
sponsor of a covered study to the investigator or the institution to 
support activities of the investigator that have a monetary value of 
more than $25,000, exclusive of the costs of conducting the clinical 
study or other clinical studies, (e.g., a grant to fund ongoing 
research, compensation in the form of equipment or retainers for ongoing 
consultation or honoraria) during the time the clinical investigator is 
carrying out the study and for 1 year following the completion of the 
study.
    (g) Applicant means the party who submits a marketing application to 
FDA for approval of a drug, device, or biologic product. The applicant 
is responsible for submitting the appropriate certification and 
disclosure statements required in this part.
    (h) Sponsor of the covered clinical study means the party supporting 
a particular study at the time it was carried out.

[63 FR 5250, Feb. 2, 1998, as amended at 63 FR 72181, Dec. 31, 1998]