[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: 21CFR54.4]

[Page 297-298]
 
                        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. 54.4  Certification and disclosure requirements.

    For purposes of this part, an applicant must submit a list of all 
clinical investigators who conducted covered clinical studies to 
determine whether the applicant's product meets FDA's marketing 
requirements, identifying those clinical investigators who are full-time 
or part-time employees of the sponsor of each covered study. The 
applicant must also completely and accurately disclose or certify 
information concerning the financial interests of a clinical 
investigator who is not a full-time or part-time employee of the sponsor 
for each covered clinical study. Clinical investigators subject to 
investigational new drug or investigational device exemption regulations 
must provide the sponsor of the study with sufficient accurate 
information needed to allow subsequent disclosure or certification. The 
applicant is required to

[[Page 298]]

submit for each clinical investigator who participates in a covered 
study, either a certification that none of the financial arrangements 
described in Sec. 54.2 exist, or disclose the nature of those 
arrangements to the agency. Where the applicant acts with due diligence 
to obtain the information required in this section but is unable to do 
so, the applicant shall certify that despite the applicant's due 
diligence in attempting to obtain the information, the applicant was 
unable to obtain the information and shall include the reason.
    (a) The applicant (of an application submitted under sections 505, 
506, 510(k), 513, or 515 of the Federal Food, Drug, and Cosmetic Act, or 
section 351 of the Public Health Service Act) that relies in whole or in 
part on clinical studies shall submit, for each clinical investigator 
who participated in a covered clinical study, either a certification 
described in paragraph (a)(1) of this section or a disclosure statement 
described in paragraph (a)(3) of this section.
    (1) Certification: The applicant covered by this section shall 
submit for all clinical investigators (as defined in Sec. 54.2(d)), to 
whom the certification applies, a completed Form FDA 3454 attesting to 
the absence of financial interests and arrangements described in 
paragraph (a)(3) of this section. The form shall be dated and signed by 
the chief financial officer or other responsible corporate official or 
representative.
    (2) If the certification covers less than all covered clinical data 
in the application, the applicant shall include in the certification a 
list of the studies covered by this certification.
    (3) Disclosure Statement: For any clinical investigator defined in 
Sec. 54.2(d) for whom the applicant does not submit the certification 
described in paragraph (a)(1) of this section, the applicant shall 
submit a completed Form FDA 3455 disclosing completely and accurately 
the following:
    (i) Any financial arrangement entered into between the sponsor of 
the covered study and the clinical investigator involved in the conduct 
of a covered clinical trial, whereby the value of the compensation to 
the clinical investigator for conducting the study could be influenced 
by the outcome of the study;
    (ii) Any significant payments of other sorts from the sponsor of the 
covered study, such as a grant to fund ongoing research, compensation in 
the form of equipment, retainer for ongoing consultation, or honoraria;
    (iii) Any proprietary interest in the tested product held by any 
clinical investigator involved in a study;
    (iv) Any significant equity interest in the sponsor of the covered 
study held by any clinical investigator involved in any clinical study; 
and
    (v) Any steps taken to minimize the potential for bias resulting 
from any of the disclosed arrangements, interests, or payments.
    (b) The clinical investigator shall provide to the sponsor of the 
covered study sufficient accurate financial information to allow the 
sponsor to submit complete and accurate certification or disclosure 
statements as required in paragraph (a) of this section. The 
investigator shall promptly update this information if any relevant 
changes occur in the course of the investigation or for 1 year following 
completion of the study.
    (c) Refusal to file application. FDA may refuse to file any 
marketing application described in paragraph (a) of this section that 
does not contain the information required by this section or a 
certification by the applicant that the applicant has acted with due 
diligence to obtain the information but was unable to do so and stating 
the reason.

[63 FR 5250, Feb. 2, 1998; 63 FR 35134, June 29, 1998, as amended at 64 
FR 399, Jan. 5, 1999]