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Diabetic Retinopathy Clinical Research Network Operations Center

糖尿病视网膜病变临床研究网络运营中心

基本信息

批准号：
8391221
负责人：
Neil Michael Bressler
金额：
$ 15.45万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-30 至 2013-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8391221
关键词：
Adherence Adverse event Ancillary Study Applications Grants Automatic Data Processing Blindness Budgets Certification Clinical Research Clinical Trials Code Collaborations Communication Communities Concept Review Conflict of Interest Consent Forms Data Data Collection Dedications Development Diabetic Retinopathy Disease Educational workshop Enrollment Fellowship Foundations Freedom Funding Future Goals Grant Guidelines Human Resources Image Image Analysis Impairment Individual Industry Industry Collaboration Institutional Review Boards Insulin-Dependent Diabetes Mellitus International Investigation Leadership Manuals Manuscripts Mediation Medical Mentors Methodology Methods Minor Monitor Newsletter Ophthalmology Performance Pharmaceutical Preparations Phase Policies Principal Investigator Procedures Process Protocols documentation Quality Control Reading Reporting Research Research Infrastructure Research Personnel Resources Retina Retinal Review Committee Role Safety Site Site Visit Specialist Specific qualifier value Staging Teleconferences Third-Party Payer Time Training Training Support United States United States National Institutes of Health Universities Vision Visual Acuity Writing base clinical research site community based practice cost diabetic electronic data financial conflict of interest follow-up interest macular edema meetings member minority subjects operation organizational structure primary outcome programs protocol development working group

项目摘要

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.

描述（由申请人提供）：糖尿病视网膜病变临床研究网络 (DRCR.net) 的目标是开发和维护一个协作网络，以促进对糖尿病视网膜病变、糖尿病黄斑水肿及相关病症的多中心临床研究，这些疾病是美国和全世界视力损伤和失明的主要原因和日益增长的原因。其优先事项包括参与基于社区的实践以及基于大学的中心，并与行业合作以促进调查和机会，否则不可能，但这样做的方式符合网络致力于学术诚信和最佳临床试验绩效的方式。在下一个资助周期内，该网络建议完成预计在资助期开始时正在进行的 5 个协议，启动大约 10 个新协议，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，通过征求新站点的参与和鼓励最近完成研究员培训的研究人员的参与来继续扩大 DRCR.net，继续对 DRCR.net 研究者进行临床研究原理教育，并指导选定的视网膜专家成为临床试验的领导者。该网络运营中心（OC）的具体目标是负责协议开发的科学监督。它还就科目注册程序提供建议；为统计分析计划提供输入；协助网络协调中心 (CC) 制定特定于协议的招募增强计划和特定于协议的收尾计划；监督负责大多数网络手稿、演示文稿、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）；为网络主席和礼宾主席提供基础设施；与外部实体（行业、FDA、基金会、其他网络）合作；认证视力检查员；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，其中许多活动已从 CC 转移到网络主席办公室。该应用程序将未来 5 年的这些活动集中在约翰·霍普金斯大学网络运营中心内。