National Eye Institute Support (NEIS)

The overall objective of this project is to provide the NEI with a Statistical and Clinical Coordinating and Monitoring Center to maintain support of ongoing and upcoming vision clinical trials and epidemiologic research. Specific objectives of this project include: (1) Application and development of new or superior study design and statistical analysis methodologies facilitating timely reporting and publication of clinical study results; (2) Maintaining mutually rewarding collaborations between EMMES professionals and NEI investigators; (3) Development, preparation and revision of manuals of procedures, study forms, and procedures across a spectrum of disease areas and research groups; (4) Storage, tracking, grading and reporting of ophthalmic imaging including digital transmission of images and grading protocols for new or experimental imaging; (5) Facilitating communication, site monitoring, and clinical staff training in GCP and study-specific requirements; (6) Maintaining NEI’s high standards for Data Quality Assurance, including integration of EDC and EHR systems for seamless submission of clinical data from the NEI; (7) Supporting preclinical requirements for the submission of Investigational New Drug requests (IND) to the FDA enabling NEI to foster translational research.