National Eye Institute Support (NEIS)

Coordinating Center
Project Status
Active
Project Lifespan
08/31/1996
Objective

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.

Population

Individuals diagnosed with one of the following conditions:
Age-related Macular Degeneration, Autoimmune Retinopathy, Diabetic Macular Edema, Macular Telangiectasia, Chorioretinopathy, Retinal Vein Occlusion, Uveitis, Graft vs. Host Disease, Von Hippel-Lindau Syndrome and Retinoschisis.

Phase
I
II
III
Pre-Clinical
Centers

National Eye Institute (NEI)

Products
AdvantageEDC
GlobalTrace
Services
Data Analysis and Reporting
Independent Data and Safety Monitoring Board Services
Medical Monitoring
Meeting Coordination and Support
Protocol Monitoring
Project Management
Regulatory Affairs
Site Selection and Contracting
Statistical Leadership and Project Management
Study Design/Protocol Development
Subject Recruitment
Training and Certification
Web-based Data Collection and Reporting Systems