Biometrical support and information infrastructure for the Priority Research Program "Age-related Macular Degeneration; biometrics, data management, and monitoring of the clinical study "MARAN - Surgical Management of Subfoveal Choroideal Membranes in AMD

该项目旨在实现三个目标：1.；建立跨项目数据库，以标准化和匿名的方式收集数据。该数据库的任务是：建立表型、遗传和成像信息的高质量文档，收集对未来临床研究计划有用的信息，支持未来AMD领域的质量保证活动，并编纂优先研究项目的临床经验，以便未来的研究人员用于meta分析等活动。其目的是激发优先研究计划项目之间的协同效应，设计跨项目研究问题，并改善各个项目之间的信息交流。2. 在优先研究计划中安装高质量的方法支持；改进病理过程的建模；引入基于模型的形态学数据与功能、生化和组织学过程结果的融合；对预后、遗传流行病学以及影像学和功能参数之间的对应关系等方面的汇总数据进行分析；支持基础研究成果向临床概念的转变（I期、II期研究）。3. 确保临床研究MARAN按照国际人用药品注册技术要求协调会议（ICH）良好临床实践指南（GCP）进行。这一目标包括方法学和生物计量学支持、数据管理和监测。

This project aims at three goals: 1. The establishing of a cross-project database which collects the data in a standardized and anonymous way. The tasks of this database are: To establish a high-quality documentation of phenotypes, genetic and imaging information, to collect information useful for the planning of future clinical studies, to support future quality assurance activities in the field of AMD, and to codify the clinical experience of the priority research program in a way to be used by future researchers for activities like meta-analyses. It is intended to stimulated synergistic effects between the projects of the priority research program, to design cross-project research problems, and to improve the exchange of information between the individual projects. 2. The installing of a high-quality methodological support within the priority research program; to improve the modelling of pathological processes; to introduce model based merging of morphological data and findings in functional, biochemical and histological processes; to initiate the analysis of pooled data with respect to problems of prognosis, genetic epidemiology, and the correspondence between imaging and functional parameters; to support the transition of results in basic research to clinical concepts (Phase I, Phase II studies). 3. To ensure that the clinical study MARAN is conducted according to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline for Good Clinical Practice (GCP). This goal consists in methodological and biometrical support, data management, and monitoring.