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	FAQ's Ask your questions, and the answers will be posted here! info@ortsedu.com Q: "Our office is small and under-staffed making it difficult to go to the all day training lectures you provide. Do you offer any other forms of training?" A: Soon, Ophthalmic Research Training Services will have multiple ways for you to continue your research education. Our monthly newsletter will announce all the details. Q: "I can't attend the seminars on the dates scheduled. Is it possible to arrange another date?" A: Yes, another date can be arranged, this is frequently done. ORTS recognizes that each office has different schedules and needs. If you would like to schedule a different date please contact ORTS at 419-343-7384. We'll be happy to arrange a date that suits your needs. Q: "Where can I find the forms on financial disclosure and other forms that I need?" A: All FDA forms can be found at the FDA website; http://www.fda.gov/opacom/morechoices/fdaforms/cder.html Note that the forms are available in Microsoft Word or Adobe PDF formats. Q: "Is it required that a study coordinator be listed on the 1572?" A: In the past it has not been a requirement for study coordinators to be listed on the FDA Form 1572. But, recently it has been happening more frequently. The sponsor will let you know if it's part of their SOP's (Standard Operating Procedures) in which case, list yourself as you would any lab, photo fundus reading center or other sub investigators. But caution should be shown if asked to sign the FDA form 1572. Q: "As a study coordinator, do I need human subjects protection education? If so, where can I get this?" A: Yes, all members of your research team are under a federal mandate requiring human subjects protection education. There is a free, web-based course that presents information about the rights and welfare of human participants in research. This will satisfy the NIH human subjects training requirements. The link is: http://www.ncicirb.org/frameit.asp?url=http://cme.nci.nih.gov Q: "As office manager, I've been asked to 'look over' the budget for a potential trial. Does either course offered, cover the items that I need to look for to 'understand' what I'm looking for? A: "Both the Basic Training A-Z and the Intermediate Training A-Z offer information on this subject. The Intermediate Training A-Z actually goes into much more detail and shows examples of what mistakes you can avoid by knowing exactly what you are looking for in the proposed budget, as well as understanding how your office overhead plays into the equation as well." Q: "Our office is just entering clinical research, does this seminar provide any information on ways to attract trials to our office?" A: Yes, that information and much more is covered, including insight on how to solicit trials to your site and then determine if a budget for a project is substantial enough to cover the real costs of performing research. Q: "A sponsor has requested that I submit my SAEs to my IRB as they occur, but the IRB states that unless it's possibly related to the study drug, I should just submit the SAEs with my next scheduled submission. What should I do?" A: Follow the guidelines of your IRB and place a Note to File in your regulation binder along with a copy of your IRB regulations on SAE submissions. Send a copy to your sponsor as well. This should take care of the situation. You've proven to the sponsor that your IRB does not require such information at that time and you've created the proper paper trail for future referrence. Q: "Our site has been notified that we will be audited by the FDA. The sponsor is sending a team for an audit as well. Should I be worried that they will both audit our site?" A: Actually, you can be relieved if the sponsor is auditing first. This will help you prepare and know ahead of time if there will be any issues that need to be addressed. More often than not, if the sponsor has monitored your site adeptly there are few problems that will come up. Remember, high enrolling sites are usually target for FDA audits. If you have performed your job proficiently and the sponsor has monitored efficiently there should be no need to worry. Q: "Will ORTS hold any seminars for intermediate study coordinator training" A: Yes, ORTS offers both BASIC TRAINING and INTERMEDIATE TRAINING A-Z seminars for study coordinators! This information can be found on the services page.   Allow Ophthalmic Research Training Services to come into your office, educate your staff, organize your research regulatory documents and set a course for success!
	For more information on ways we can customize training to fit your needs, please contact us at:   419-343-7384 info@ortsedu.com

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