Data Coordination and Biostatistics Center for the NORDIC Network

描述（由申请人提供）：该资助申请是Mark Kupersmith博士为神经-眼科学研究疾病研究者联盟（NORDIC）提交的申请的补充。该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的功能详列于附件的个别申请表。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协作。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、程序手册和知情同意模型；制定综合数据管理计划。其他项目协调任务包括：必要时从适用的监管机构（如FDA、加拿大卫生部）获得并保持适当的批准；相关规范性文件的识别和收集；培训现场人员；研究药品采购、包装和配送；跟踪和报告研究事件，与北欧项目所需的其他供应商签订合同并进行管理（例如，中央实验室）。其他数据管理活动包括：开发和提供电子病例报告表（eCRFs）；培训网站使用eResearch Technology的基于网络的电子数据采集系统；跟踪和清理项目数据库；并生成报告，保证数据收集的及时性和准确性。其他生物统计活动包括进行最后分析和为研究出版物撰稿；与DSMC联络，编制报告；进行和报告二次分析和探索性分析。临床和生物统计人员已成功合作超过150年的数十个多中心临床研究项目。这种经验将支持北欧项目的成功实施。从公共卫生的角度来看，与DCBC、VFRC和PRC一起创建北欧网络具有重要意义，因为它为开展广泛的前瞻性研究提供了必要的基础设施，这些研究将正确评估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.