[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: 21CFR54.2]
[Page 291-292]
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 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,
[[Page 292]]
(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]
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