Data Coordination and Biostatistics Center for the NORDIC Network

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DESCRIPTION (provided by applicant): This grant application is a companion to the application submitted by Dr. Mark Kupersmith for the Neuro-Ophthalmology Research Disease Investigator Consortium (NORDIC). This application describes a Data Coordination and Biostatistics Center (DCBC), a Visual Field Reading Center (VFRC) and a Photography Reading Center (PRC) that together will provide the crucial infrastructure for the conduct of the NORDIC projects described in Dr. Kupersmith's application. The functions of the VFRC and PRC are detailed in the attached individual applications. The DCBC will provide all project coordination, data management and biostatistical collaboration for all NORDIC projects. DCBC personnel will play a central role in the formulation of each project including: refining study hypotheses and analytic plans; concretizing the project in a study protocol, manual of procedures, and model informed consent; and developing an integrated data management plan. Additional project coordination tasks include: obtaining and maintaining appropriate approvals from applicable regulatory agencies (e.g., FDA, Health Canada) as necessary; identification and collection of relevant regulatory documents; training of site personnel; study drug procurement, packaging and distribution; tracking and reporting study events, contracting with and managing other vendors needed in NORDIC projects (e.g., central laboratory). Additional data management activities include: developing and providing access to electronic Case Report Forms (eCRFs); training sites in the use of electronic web-based data capture system from eResearch Technology; tracking and cleaning project databases; and generating reports of data collection timeliness and accuracy. Additional biostatistical activities include conducting final analyses and contributing to study publications; liaising with the DSMC for report generation; and conducting and reporting secondary and exploratory analyses. The clinical and biostatistical personnel of the DCBC have successfully collaborated for over >15 years on dozens of multicenter clinical research projects. This experience will support the successful conduct of NORDIC projects. The creation of the NORDIC Network with the DCBC, VFRC, and PRC is significant from a public health standpoint in that it provides the essential infrastructure to perform wide reaching prospecitve research that will properly evaluate potential treatments in neuro-ophthalmalogic disorders that collectively affect millions of people.