olympus corporation of the americas 3500 corporate parkway, p.o. box 610, center valley, pa 18034-0610 telephone (484) 896-5000 cnxxxxxxxcv fm-sop-032-03
FINANCIAL DISCLOSURE FORM This form must be completed by each Sponsor-Investigator to ensure compliance with 21 CFR Parts 54, 312, 314, 320, 330, 601, 807, 812, 814 and 860. Title of Study/ Protocol (the Study): Company (the Company): Olympus Corporation of the Americas After reading each of the questions below, please mark the appropriate answer box to the right of the question. *Note that the term "you" below also applies to your spouse and each dependent child QUESTION YES NO 1. Are you* a direct employee of the Company on a part-time or full-time basis? 2. Do you* have any financial arrangement with the Company whereby the value of compensation to the Investigator could be influenced by the outcome of the Study (e.g. higher compensation for a favorable outcome than for an unfavorable outcome whereby compensation may be in the form of monetary payment, equity interest in Company, compensation tied to Product sales such as a royalty interest)? 3. In addition to the Company's payment for the conduct of the Study, do you* or your institution receive other significant payments from the Company (such as a grant to fund other on-going research, compensation in the form of equipment, retainer for consultation or honoraria) in support of your activities in an amount totaling more than US $25,000.00 during the time you are carrying out the Study or for 1 year following the completion of the Study? 4. Do you* have any proprietary interest in the Product(s) being tested in the Study (such as patent, trademark, copyright or license rights)? 5. Do you* have any significant equity interest in the Company (such as ownership, stock options or other financial interest whose value cannot be readily determined through reference to public prices) that has a monetary value of more than US $50,000.00 during the time you are carrying out the Study and for 1 year following the completion of the Study? If you have answered YES to any of the above questions, please elaborate on the dollar value(s) and nature of the arrangement(s) and describe any steps that are taken to minimize the potential for bias resulting from any of the disclosed arrangements, interests and/or payments: ______________________________________________________________________________________________ ______________________________________________________________________________________________ Please append accurate documents to confirm such arrangement(s) and/or course(s) of action, as needed. I certify that the foregoing responses and information are complete and accurate. I hereby acknowledge that this information will be provided to the Company for preparation and submission to the FDA (as applicable) for the clinical investigator financial interest certification and disclosure statements required under 21 CFR Part 54. I shall promptly provide the Company any update to this information if any relevant changes occur in the course of the Study and for a period of one (1) year following the completion of the Study. Name of Sponsor-Investigator [Please print] Signature of Sponsor-Investigator Date ______________________________________ __________________________ _____________ OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY, P.O. BOX 610, CENTER VALLEY, PA 18034-0610 TELEPHONE (484) 896-5000 CNXXXXXXXCV FM-SOP-032-03Microsoft Word 2016 Microsoft Word 2016