Ophthalmic Research Training - Clinical Research Training Ophthalmologist & Ophthalmology

Ophthalmic Research Training
9050 Summerfield Rd
Temperance, MI 48182

Telephone:

(419) 343-7384

Frequently Asked Questions

Ophthalmology is a branch of medicine which deals with the diseases and surgery of the visual pathways, including the eye, hairs, and areas surrounding the eye, such as the lacrimal system and eyelids. The term ophthalmologist is an eye specialist for medical and surgical problems. Since ophthalmologists perform operations on eyes, they are considered to be both a surgical and medical specialty. The word ophthalmology comes from the Greek roots ophthalmos meaning eye and logos meaning word, thought or discourse; ophthalmology literally means "the science of eyes". Ophthalmic Research Training Services provides Clinical Research Training for this medical discipline.

Ophthalmologists are medical doctors (M.D.) or Doctors of Osteopathic Medicine (D.O.) who have completed a college degree, medical school, and an additional four years of postgraduate training in ophthalmology in many countries. Many ophthalmologists also undergo additional specialized training in one of the many subspecialities. Ophthalmology was the first branch of medicine to offer board certification, now a standard practice among all specialties. Ophthalmic Research Training Services provides Clinical Research Training for this medical discipline.

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Q:	"How can I get the training I need?"

A:	Ophthalmic Research Training Services has multiple ways for you to continue your research education. On Site Training - we'll come to your office and train the research team. Seminars - all day events in our training facility. Training Modules - workbook, templates and 3 - 1 hour - one on one training sessions to maximize the training module. Self Learning Training Modules - CDs and workbooks designed for those who prefer the self taught approach.

Q:	"We've heard horror stories of audits... how do we prevent becoming one?"

A:	Simple, perform each aspect of clinical research the right way following GCPs and your SOPs and you won't have a thing to worry about. If you know you're lacking or worse yet don't know about GCPs or SOPs for clinical research or they are weak... NOW is the time to obtain the training you need to shine in the performance department and fly through any audit with flying colors!

Q:	"Where can I find the guidance documents on specific things?"

A:	All FDA Guidance Documents can be found at the FDA website; http://www.fda.gov/RegulatoryInformation/Guidances/default.htm

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. The FDA recently released clarification guidance and can be found on the Industry Guidance page.

Q:	"As a PI, Sub Investigator or Study Coordinator, do I need human subject's protection education? If so, where can I get this?"

A:	Yes, all members of your research team are under a federal mandate requiring human subject's 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:	Ophthalmic Research Training Services offers many ways to obtain specific training in that area. (THIS SHOULD BE LINKED OT THE TRAINING BARS for SEMINARS)

Q:	"Our office is just entering clinical research, do these seminars/trainings 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 reference.

Q:	"Help! We have a horrible monitor. What do we do?"

A:	Sadly this does occur from time to time, more common I hear that the monitor does not have any ophthalmic background which cause many ophthalmic study coordinators concern. There are many things you can do to help ease the situation. Learn more about the GCPs for Monitors. (located on our Industry Guidance page) We also offer a Training Module designed to help you prepare for the monitor visit, track the success and follow through so that each interim monitoring visit is painless for the site and the monitor!

Q:	"Do we really need research SOPs?"

A:	ABSOLUTELY!!!! Besides needing them, if your site already has them in place, it's in your best interest to review and up date them. Recent QA Audits indicate that although many sites have them they are considered to be very weak. Our Training Modules offer the help to make your Standard Operating Procedures Robust!

Q:	"I have a confidential question, how can I reach you to speak personally about this?"

A:	Click on the Contact Us bar and you can email or call with your confidential questions.

Get started on the right Clinical Research Training plan today. It's so easy, just email or call me for a free confidential consultation of your research needs.