Ophthalmic Research Training - Clinical Research Training Ophthalmologist & Ophthalmology

Ophthalmic Research Training
9050 Summerfield Rd
Temperance, MI 48182

Telephone:

(419) 343-7384

Industry Guidance

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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FDA Clinical Trial Guidance Documents: Click Here
Guidance For Industry: Investigator Responsibilities, Protecting the Rights, Safety and Welfare of Study Subjects (October 2009) Click Here
Guidance For Clinical Investigators, Sponsor's and IRB's: Adverse Event Reporting to IRB's, Improving Human Subject Protection (January 2009) Click Here
Information Sheet Guidance for Sponsor's, Clinical Investigator's and IRB's: Frequently Asked Questions Statement of Investigator (Form FDA 1572)(May 2010) Click Here
Information Sheet Guidance for Institutional Review Boards, Clinical Investigators and Sponsors: Clinical Investigator Administrative Actions- Disqualification (May 2010) Click Here
Guidance for Industry: Guidelines for the Monitoring of Clinical Investigations(January 1988) Click Here
Guidance for Industry: Part 11, Electronic Signatures- Scope & Application (August 2003) Click Here
Guidance Financial Disclosure by Clinical Investigators (May 2001) Click Here
Guidance for Industry: E6 Good Clinical Practice Consolidated Guidance (April 1996) Click Here
Guidance for Industry and Clinical Investigators: The Use of Clinical Holds Following Clinical Investigator Misconduct (September 2004) Click Here

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