Data Coordination and Biostatistics Center for the NORDIC Network

描述(由申请者提供)：这项拨款申请是马克·库珀史密斯博士向北欧眼科研究疾病调查员联盟提交的申请的一部分。本申请描述了一个数据协调和生物统计中心(DCBC)、一个视野阅读中心(VFRC)和一个摄影阅读中心(PRC)，它们将共同为Kupersmith博士的申请中描述的北欧项目的实施提供关键的基础设施。VFRC和PRC的功能在所附的个别申请中有详细说明。DCBC将为所有北欧项目提供所有项目协调、数据管理和生物统计合作。DCBC人员将在每个项目的制定中发挥核心作用，包括：完善研究假设和分析计划；将项目具体化为研究方案、程序手册和模式知情同意；以及制定综合数据管理计划。其他项目协调任务包括：必要时获得和维护适用监管机构(例如FDA、加拿大卫生部)的适当批准；确定和收集相关监管文件；培训现场人员；研究药品采购、包装和分销；跟踪和报告研究事件；与北欧项目所需的其他供应商(例如中央实验室)签约并进行管理。其他数据管理活动包括：开发和提供电子案例报告表；培训网站如何使用eResearch Technology基于网络的电子数据采集系统；跟踪和清理项目数据库；生成数据收集及时性和准确性报告。其他生物统计活动包括：进行最终分析并为研究出版物作出贡献；与生物统计中心联络以生成报告；进行和报告二次和探索性分析。DCBC的临床和生物统计人员在数十个多中心临床研究项目上成功合作了15年。这一经验将有助于北欧项目的成功实施。从公共卫生的角度来看，与DCBC、VFRC和PRC建立北欧网络具有重要意义，因为它为执行广泛的前瞻性研究提供了必要的基础设施，这些研究将适当地评估共同影响数百万人的神经眼科疾病的潜在治疗方法。

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.