Mark-up Attachment E03 CTEP Financial Disclosure

Form Approved: OMB No. 0925-0753
Expiration Date: 7/31/2021
Collection of this information is authorized under 21 CFR: Part 54 [sections 2 and 4] and Part 312 [sections 53(c)(4) and 64(d)] 312.53. The primary use is to identify qualified investigators to participate in clinical
investigations at the National Cancer Institute 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 researchers for research purposes, sponsors of clinical trials, the applicable Institutional Review Board, 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 to qualify to conduct studies in accordance with the relevant regulatory
requirements, you must complete all fields.
Public reporting burden for this collection of information is estimated to average5 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 conductor 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
ClearanceBranch,6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0753). Do not return the completed form to this address.

CONFIDENTIAL
FINANCIAL DISCLOSURE FORM
The following confidential financial disclosure information is being collected for all investigators in accordance with 21
CFR: part 54 and Part 312 [sections 53(c)(4) and 64(d)]. Any pharmaceutical or medical device company that submits
a marketing application for any drug, biologic product, or device is required to submit certain information concerning
the compensation to, and financial interests of, any clinical investigator participating in any clinical study submitted in
the marketing application. The Cancer Therapy Evaluation Program (CTEP) is collecting this confidential information
annually for all CTEP-registered investigators and sub-investigators.
*Please indicate below if note that ‘You’ below refers to you, your spouse, or dependent children have regarding any
of the following disclosable financial arrangements.

Yes

No

Do yYou* currently have or have you at any time in the past year had any financial
arrangement with a pharmaceutical, biologic, or medical device company whereby the
value of the compensation could be influenced by the outcome of the study
outcomes?

Yes

No

Have Do yYou* currently have or have you at any time in the past year had any significant
payments of other sorts totaling $25,000 or more made on or after February 2, 1999, as
defined in 21 CFR 54.2(f), made to you or to your institution from a pharmaceutical,
biologic, or medical device company, such as a grant to fund ongoing research,
compensation in the form of equipment, retainer for ongoing consultation, or honoraria?

Yes

No

Do yYou* currently have or have you at any time in the past year had any
proprietary interest in any drug, biologic product, or medical device?

Yes

No

Do yYou* currently have or have you at any time in the past year had any significant
equity interest, as defined in 21 CFR 54.2(b), in a pharmaceutical, biologic, or medical
device company?

If you answered “Yes” to any of the questions above, please provide the name of the pharmaceutical, biologic, or
medical device company or companies with whom the financial arrangement exists.
PHARMACEUTICAL, BIOLOGIC, OR MEDICAL DEVICE COMPANY OR COMPANIES
CTEP Company Code

Company Name

Company Address

ACKNOWLEDGEMENT



AGREEMENT: By signing this Electronic Signature Acknowledgment Form, I attest to the accuracy and integrity of this document and agree
that my electronic signature is the legally binding equivalent to my handwritten signature. Whenever I execute an electronic signature, it has
the same validity and meaning as my handwritten signature. I will not, at any time in the future, repudiate the meaning of my electronic
signature or claim that my electronic signature is not legally binding.
The complete NCI registration documents will by maintaining by the Pharmaceutical Management Branch, CTEP as part of your
confidential investigator registration file and will be kept private, under the Privacy Act. This I Information collected on this form will only
be provided (1) to a pharmaceutical company which has an agreement (e.g., a Clinical Trials Agreement [CTA] or a Cooperative Research
and Development Agreement [CRADA]) with CTEP if CTEP is notified that a licensing application is being prepared by that company, (2) to
a Network or Group of which you are a member if CTEP is notified that a clinical trial is being developed by that Network or Group and a
pharmaceutical company with whom you have indicated a financial arrangement, or (3) the Food and Drug Administration. You may be
contacted in the future by a pharmaceutical company representative or by your Network or Group administrative staff for additional
information.

FORM FDA 3455 (Rev. 31-JUL-2018)

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SIGNATURE

DATE

This is an electronic signature and is the legally binding equivalent to a handwritten signature.

(WARNING: A willfully false statement is a criminal offense. U.S.C. Title 18, Sec.1001.)

FORM FDA 3455 (Rev. 31-JUL-2018)

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