Disclosure of Compensation and Financial Interestspage 1

Disclosure of Compensation and Financial InterestsPage 1

Sponsor: / Protocol #: / Submission: / Initial Revised
Site: / Site #:
Investigator: / First Name: / Middle: / Last: / Suffix:
Definitions & Instructions: The term “Investigator” means the principal investigator or subinvestigator completing this form. The term “Sponsor” includes Sponsor’s parent, subsidiaries and affiliates, if any. The term “you” includes entities owned or acting on your behalf, including your employer. This form applies to the “Reporting Period” of the Study, starting with the signature date on the Investigator’s FDA Form 1572 or Statement of Investigator and concluding one year after the Investigator’s Study close-out visit. Submit this form to Sponsor during study start-up. If any significantchanges occur during the “Period of the Study,”promptly submit a new, updated form.
Questions about Compensation and Financial Interests
YES NO / 1. Do you, your spouse, and any dependent childrencollectively own or have an agreement to potentially own anystock, stock derivative, American Depository Receipt, or other equity interest in Sponsor with a value exceeding US$50,000, based on publicly available prices? If YES, list the equity interests, state their approximate value, and describe below.
YES NO / 2. Do you, your spouse, or a dependent child ownany stock, stock option, or other financial interest in Sponsor for which the value cannot be readily determined from publicly available prices? If YES,list the financial interests and describe below.
YES NO / 3. Do you, your spouse, or a dependent child have any proprietary or financial interest in the Study test article, such as a patent, trademark, copyright, royalty, license or compensation tied to product sales? If YES, describe below.
YES NO / 4. Do you, your spouse, or a dependent child have any bonus or other financial arrangement with Sponsor, the value of which might be favorably influenced by the outcome of the Study? If YES, describe below.
YES NO / 5. Have you, your spouse, or any dependent children received or contracted to receive grants to fund ongoing research; consulting, contracting, speaking, committee, advisory board, or market research fees, honoraria or retainers; equipment useful outside the Study; travel and entertainment that exceed reasonable expectations to conduct the study; gifts; or other payments from Sponsor, cumulatively exceeding US$25,000, excluding this and other clinical studies? If YES, describe below, including the date, approximate amount, and reason for each item.
YES NO / 6. Are you, your spouse, or a dependent child a full-time or part-time employee of Sponsor? If YES, describe below.
Description of Compensation and Financial Interests
Question # / Person / Compensation or Financial Interest
In accordance with US. Code of Federal Regulations 21 CFR 54, 312 and 812, I certify that the information on this form, to the best of my knowledge and belief, is true, correct and complete for the Reporting Period. I agree to follow the instructions above. I consent to the transfer of the information on this form to Sponsor or its applicable contractors in any country they are located, the U.S. Food and Drug Administration (FDA), other governmental regulatory authorities, including those outside the U.S. if legally required, and ethics committees (institutional review boards) to which Sponsor is required by law or ethics committee policy to disclose such information. Sponsor will otherwise keep this information confidential. The FDA and certain other governmental authoritiesmay disclose this information under certain legally permitted circumstances.
Investigator signature: Date: