Diabetic Retinopathy Clinical Research Network Operations Center

描述（由申请人提供）：糖尿病视网膜病变临床研究网络（DRCR.net）的目标是发展和维护一个合作网络，以促进糖尿病视网膜病变、糖尿病黄斑水肿和相关疾病的多中心临床研究，这些疾病是美国和世界各地视力损害和失明的主要和日益增长的原因。其优先事项包括参与以社区为基础的实践以及以大学为基础的中心，并与工业界合作，以促进调查和机会，否则是不可能的，但要以与网络致力于学术诚信和最佳临床试验性能一致的方式这样做。在下一个资助周期，该网络建议完成预计在资助期开始时正在进行的5项方案，启动大约10项新方案，开发和实施视网膜图像电子数据捕获的新方法，以促进糖尿病视网膜病变临床试验的进行。通过邀请新站点的参与和鼓励最近完成奖学金培训的研究人员的参与，继续扩大DRCR.net，继续对DRCR.net研究人员进行临床研究原则的教育，并指导选定的视网膜专家成为临床试验的领导者。网络运营中心（OC）的具体目标是负责对协议开发进行科学监督。它还就受试者登记的程序提供建议；为统计分析计划提供输入；协助网络协调中心（CC）制定特定协议的招聘增强计划和特定协议的关闭计划；监督负责大多数网络手稿、演示、辅助研究、财务利益冲突、质量控制和协议概念的成员；协调大多数网络委员会、会议和电话会议（例如，制定议程、安排电话会议和会议并提供会议记录）；为网络主席和协议主席提供基础设施；与外部实体（行业，FDA，基金会，其他网络）合作；为视力检验师签发证明书；并提供有关视网膜图像采集和视网膜图像分析的专业知识。自2006年以来，许多此类活动已从协调委员会转移到网络主席办公室。该应用程序在未来5年内将这些活动集中在约翰霍普金斯大学的网络运营中心内。

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.