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

• 批准号: 8212542
• 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
• 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/8212542
• 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

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）：糖尿病性视网膜病变临床研究网络（DRCR.NET）的目的是开发和维持一个协作网络，以促进有关糖尿病性视网膜病变，糖尿病性黄斑水肿，相关状况，领导和不断增长的原因和不断增长的原因和不断增长的病因和不断增长的原因和不断增长的原因和不断增长的原因。它的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，否则就无法做到，但以与网络对学术诚信和最佳临床试验表现一致的方式这样做。在下一个融资周期中，该网络建议完成5个方案，预计在资金开始时将进行，启动大约10个新协议，开发和实施新的方法来电子数据捕获视网膜图像，以促进糖尿病性视网膜病变临床试验的进行，并继续促进持续的临时培训，并通过延长fell.net的范围，并启动了新的参与，以促进新的参与，以使参与的参与度参与了参与，使得参与，并促进参与的参与。为了教育drcr.net研究人员有关临床研究原理的教育，导师选择的视网膜专家是临床试验的领导者。网络的运营中心（OC）具体目的是负责协议开发的科学监督。它还为受试者入学的程序提供建议；提供统计分析计划的意见；协助网络协调中心（CC），以特定于协议的招聘增强计划和协议特定的关闭计划；监督负责大多数网络手稿，演示，辅助研究，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，会议和电信会议（例如，设置议程，安排和提供电视会议和会议的会议记录）；为网络主席和协议主持人提供基础架构；与外部实体（行业，FDA，基金会，其他网络）合作；证明视力检查员；并提供有关视网膜图像获取和视网膜图像分析的专业知识。自2006年以来，这些活动中的许多活动已从CC转移到网络主席办公室。本申请将这些活动集中在接下来的5年中，在网络运营中心约翰·霍普金斯（Johns Hopkins）的网络运营中心。