Ophthalmic Clinical Trial Training and Certification (OCTTC)

Coordinating Center
Additional Information

The service area of Ophthalmic Training and Certification at The EMMES Corporation offers proven solutions for the training and certification of visual function examiners participating in Ophthalmic clinical trials.
Our clients consist of pharmaceutical companies that are conducting phase I-III ophthalmic clinical trials who wish to ensure the data for the primary outcome of their study is collected in a standardized way. The use of the Early Treatment Diabetic Retinopathy Study (ETDRS) protocols for performing manifest refraction and assessing visual acuity serve as the leading industry standard in the conduct of ophthalmic clinical trials. These protocols help to assure uniformity of measurements when gathering these important outcome data. Our study sponsors are assured that personnel at clinical centers are applying protocols correctly.
In addition to using the ETDRS protocols, The EMMES Corporation trains and certifies in these other ophthalmic tasks which include: Electronic Visual Acuity (EVA)system, Pelli-Robson Contrast Sensitivity testing, NEI Visual Function Questionnaire 25(NEI VFQ-25), Standard of Life Questionnaire 36 (SF-36), Tonometry and Humphrey Visual Fields. EMMES offers a variety of certification options to accommodate our sponsors certification needs. Site certification visits, training and certification meetings and grandfathering existing EMMES certified ophthalmic staff are a few ways to obtain certification. The EMMES Corporation also trains sponsor Clinical Research Associates (CRA) to certify ophthalmic examination lanes to help studies commence.
EMMES maintains a database that includes more than 600 clinical centers world- wide(both academic institutions and private practices) and the certification status of each of these clinical centers. Site certification is included in the EMMES database after a site visit, training/certification meeting or grandfathered certification has been completed.
The EMMES Corporation employs full-time ophthalmic certification staff who have extensive experience in ophthalmic clinical trials in academic institutions and private practice settings. In addition, EMMES has contracted with 14 consulting certifiers located throughout the continental US, Europe and Australia. EMMES ophthalmic certifiers are highly credentialed and many serve on the faculties of national organizations involved in the training and certification of allied health professionals. All EMMES certifiers are expected to adhere to the highest professional standards in the conduct of research and to represent our sponsors with objectivity, uniformity and integrity.

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