Ophthalmic Research Training - Clinical Research Training Ophthalmologist & Ophthalmology

Ophthalmic Research Training
9050 Summerfield Rd
Temperance, MI 48182

Telephone:

(419) 343-7384

Standard Operating Procedures for the Clinical Research Office - More Than Just a Manual!

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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Ophthalmic Research Training Services - Clinical Research Training

The first question of many FDA audits begins with... "Can I see your SOP's?" Be prepared for this question with Standard Operating Procedures in your office.

Too frequently this question is answered with a deer in the headlights look. Prevent problems before they occur with careful SOP preparation. If poorly written, SOPs are of little value. If well written but not followed by all members of the staff, well, they fall into the same category as poorly written SOPs.

With new guidance by the FDA on Principle Investigator responsibility and delegation authority, it's more important than ever before to have current SOPs that reflect the guidelines set out by the FDA.

Whether you choose an in depth detailed version or a generalized format, just make sure you have all the bases covered. This seminar shows you samples of each including the pitfalls of too much or too little information.

Standard Operating Procedures not only act as guidance for the sponsor, but for the investigative site and the research staff as well.

SOPs detail the work processes that are conducted in the clinical research practice. When used as part of the training and direction for new employees, or as performance evaluations, or guidance on office policies. SOPs are an important part of any practice and shouldn't be overlooked.

Ultimately, the value of SOPs is a reduced work effort along with improved data comparability as well as creditability and legal defensibility.

What You Will Learn

In this seminar you will:

Understand the elements of the well-developed Standard Operating Procedures.
Basic content requirements for Standard Operating Procedures.
Why and how SOP's can be utilized in the research practice.
Outline the key points and how to make the most of your SOP's.
Ways to make SOP's a part of your daily research activities.
Templates to create your own SOPs that are professional.

Bonuses

The Tools & Templates Guide is part of the registration fee and the training manual is part of the class materials provided.

Length of Seminar

This seminar is a full 8-hour training session.

Location of Seminar

This seminar is held at our Training Facility in Dundee, MI.

Or, it can be held in your office or any city in the country.

Please contact us at 419-343-7384 for more information.