6 Attach 5B Financial Disclosure DCP

Investigational Agent Accountability Record Forms in the Conduct of Investigational Trials in Cancer Treatment (NCI)

Attach_5B-Financial Disclosure_DCP - Copy

Financial Disclosure Form (Attachments 5A or 5B)

OMB: 0925-0613

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National Cancer Institute, Division of Cancer Prevention (NCI, DCP)
FINANCIAL DISCLOSURE FORM

Form Approved: OMB No. 09125-0613
Expiration Date: XX/XX/2016

TO BE COMPLETED BY INVESTIGATOR

Collection of this information is authorized under 21 CFR 54.4. The use of this information is to disclose or certify information concerning
the financial interests of the clinical investigators associated with clinical studies. This information may be disclosed to sponsors of clinical
trials, National Cancer Institute, Food and Drug Administration’s Center for Drug Evaluation and Research and Center for Biologics
Evaluation and Research, and the Department of Health and Human Services.Submission of this information is voluntary, however, in
order for us to qualify you to conduct a study in accordance with the relevant, current protocol(s), you must complete all fields.
Public reporting burden for this collection of information is estimated to average 5 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. 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. Send comments regarding this burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974,
Bethesda, MD 20892-7974, ATTN: PRA (0925-0613). Do not return the completed form to this address.

The following information concerning
participating as a clinical investigator in the study:

who is

is submitted in accordance with 21 CFR part 54. Indicate by marking YES or NO if any of the financial interests or
arrangements as described below apply to you, your spouse, or dependent children cumulatively. If the information changes
during the course of the study or within one year after completion of the study, please notify NCI, DCP.

YES

NO
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 (For example,
compensation that is explicitly greater for a favorable outcome, or compensation to the investigator in the
form of an equity interest in the sponsor or in the form of compensation tied to sales of the product, such as
a royalty interest.) If yes, please attach details on a separate sheet.
Any significant payments of other sorts made on or after February 2, 1999, from the sponsor of the covered
study, excluding the costs of conducting this or any other clinical studies. This could include payments
made to the investigator or institution to support activities that have a cumulative monetary value greater
than $25,000 (i.e., a grant to fund ongoing research, compensation in the form of equipment, retainer for
ongoing consultation, or honoraria). If yes, please attach details on a separate sheet.
Any proprietary or financial interest in the product tested in the covered study such as a patent, trademark,
copyright, or licensing agreement. If yes, please attach details on a separate sheet.
Any significant equity interest in the sponsor, defined in 21 CFR 54.2(b), as 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
one year following completion of the study

OR

I hereby certify that none of the financial interests or arrangements listed above exist for myself, my
spouse, or my dependent children.

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)


File Typeapplication/pdf
File TitleSUGGESTED
Authorljo
File Modified2015-09-11
File Created2010-11-02

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