Diabetic Retinopathy Clinical Research Network Operations Center

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DESCRIPTION (provided by applicant): The objective of the Diabetic Retinopathy Clinical Research Network (DRCR.net) is to develop and maintain a collaborative network to facilitate multicenter clinical research on diabetic retinopathy, diabetic macular edema and associated conditions, leading and growing causes of vision impairment and blindness in the United States and throughout the world. Its priorities include involvement of community-based practices as well as university-based centers and to collaborate with industry to facilitate investigations and opportunities otherwise not possible, but to do so in a manner consistent with the Network's dedication to academic integrity and optimal clinical trial performance. During the next funding cycle, the Network proposes to complete 5 protocols that are expected to be in progress at the time the funding period begins, initiate approximately 10 new protocols, develop and implement new methods for electronic data capture of retinal images to facilitate the conduct of diabetic retinopathy clinical trials, continue to expand the DRCR.net by soliciting the participation of new sites and encouraging the involvement of investigators who recently have completed fellowship training, continue to educate the DRCR.net investigators on the principles of clinical research, and mentor selected retina specialists to be leaders in clinical trials. The Network's Operations Center (OC) specific aims are to be responsible for the scientific oversight of protocol development. It also advises on procedures for subject enrollment; provides input to statistical analysis plans; assists the Network's Coordinating Center (CC) with protocol-specific recruitment enhancement plans and protocol- specific closeout plans; oversees members responsible for most Network manuscripts, presentations, ancillary studies, financial conflicts of interest, quality control, and protocol concepts; coordinates most Network committees, meetings, and teleconferences (e.g., setting up agendas, arranging and providing minutes for teleconferences and meetings); provides infrastructure for the Network Chair and Protocol Chairs; collaborates with outside entities (industry, FDA, foundations, other networks); certifies visual acuity examiners; and provides expertise regarding retina image acquisition and retina image analysis. Many of these activities have transferred from the CC to the office of the Network Chair since 2006. This application centralizes these activities during the next 5 years within the Network's Operations Center at Johns Hopkins.