FORM FDA 3455 UCM048310
User Manual: 3455
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
DISCLOSURE: FINANCIAL INTERESTS AND
ARRANGEMENTS OF CLINICAL INVESTIGATORS
Form Approved: OMB No. 0910-0396
Expiration Date: March 31, 2019
TO BE COMPLETED BY APPLICANT
The following information concerning
Name of clinical investigator
, who participated
as a clinical investigator in the submitted study
Name of
clinical study
is submitted in accordance with 21 CFR part 54. The
named individual has participated in financial arrangements or holds financial interests that are
required to be disclosed as follows:
Please mark the applicable check boxes.
any financial arrangement entered into between the sponsor of the covered study and the clinical
investigator involved in the conduct of the covered study, whereby the value of the compensation
to the clinical investigator for conducting the study could be influenced by the outcome of the
study;
any significant payments of other sorts made on or after February 2, 1999, 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;
any proprietary interest in the product tested in the covered study held by the clinical
investigator;
any significant equity interest, as defined in 21 CFR 54.2(b), held by the clinical investigator in
the sponsor of the covered study.
Details of the individual’s disclosable financial arrangements and interests are attached, along with a
description of steps taken to minimize the potential bias of clinical study results by any of the
disclosed arrangements or interests.
NAME TITLE
FIRM/ORGANIZATION
SIGNATURE Date (mm/dd/yyyy)
This section applies only to the requirements of the Paperwork Reduction Act of 1995.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. Public reporting burden for this
collection of information is estimated to average 5 hours per response, including time for reviewing
instructions, searching existing data sources, gathering and maintaining the necessary data, and
completing and reviewing the collection of information. Send comments regarding this burden estimate
or any other aspect of this collection of information to the address to the right:
Do NOT send your completed form to
the PRA Staff email address below.
Department of Health and Human Services
Food and Drug Administration
Office of Operations
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
FORM FDA 3455 (3/16) PSC Publishing Services (301) 443-6740 EF
