[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: 21CFR54.4]
[Page 292-293]
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 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
[[Page 293]]
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]
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