Core D - Human Subjects and Analytical Core

项目总结（见说明）： 在过去的几年里，人类受试者研究的复杂性大大增加，对隐私保护，研究道德行为以及仔细和可用的数据采集的需求有了更大的认识。调查人员在启动研究方面面临一些额外要求，往往导致项目进展的过度拖延和损害。此外，随着数据集变得更加复杂并且经常与从患者获取生物样本相关联，对改进的数据收集、样本获取以及与临床数据的关联的需求日益增加。认识到人类受试者研究的巨大复杂性和个体研究者面临的障碍，我们在RDRCC内开发了一个中央核心来导航和解决这些问题。人类受试者研究和分析核心的总体目标是简化和集中RDRCC内人类受试者研究的启动和实施过程。 核心的具体目标是：1）。从研究开始阶段开始，通过各种批准步骤、研究启动和持续的监管要求，为人类受试者研究的监管和操作过程提供帮助; 2.）为研究者提供临床和转化研究设计的中心资源，以便考虑适当的统计学因素。 3.）第三章提供一个系统，用于数据库开发和维护，以及创建数据表单并使用基于Teleform的平台将其与数据库连接，并通过安全的基于Web的平台和平板电脑平台直接获取数据;以及为标本编码、存档、跟踪和检索提供一个通用平台和中央资源，并通过集成条形码系统与临床数据相关联。 该核心由克利夫顿宾厄姆博士和乔纳森艾伦博士领导，汇集了两名经验丰富的临床和翻译研究人员，他们在人类受试者研究的各个方面都有经验，包括纵向队列研究，生物标志物分析，人类病理组织研究，干预研究，临床结局测量和人类疾病的跨学科研究。所提供的服务将与其他RDRCC核心和风湿病中心整合。该核心将与约翰霍普金斯的其他资源对接，为研究者提供额外的咨询和培训。

PROJECT SUMMARY (See instructions): In the last several years, the complexity of human subjects research has increased substantially with a greater appreciation of the need for privacy protection, ethical conduct of research, and careful and usable data acquisition. Investigators face a number of additional requirements to initiate studies, often leading to excessive delays and impairment of progress on projects. Moreover, as datasets become more complex and are frequently linked with the acquisition of biological specimens from patients, there are increasing demands for improved data collection, sample acquisition, and linkage to clinical data. Recognizing the great complexity of human subjects research and the barriers faced by individual investigators, we have developed a Central Core within the RDRCC to navigate and address these concerns. The overall goal of the Human Subjects Research and Analytical Core is to streamline and centralize the process for the initiation and operationalization of human subject research within the RDRCC. The Specific Aims of the Core are: 1 .)To provide assistance for the regulatory and operational process of human subject research beginning at the study inception phase, through various approval steps, study initiation, and continuing regulatory requirements; 2.)To provide a central resource to investigators for clinical and translational study design so that appropriate statistical considerations are taken into account. 3.) To provide a system for database development and maintenance, and the creation of data forms and their linkage with databases using a Teleform-based platform and direct data acquisition via secure Web based and tablet computer platforms; and 4.)To provide a common platform and central resources for specimen coding, archiving, tracking and retrieval, and linkage with clinical data through an integrated barcoding system. This core is led by Dr. Clifton Bingham and Dr. Jonathan Ellen bringing together two seasoned clinical and translational researchers with experience in various aspects of human subjects research, ranging from longitudinal cohort studies, biomarker analysis, studies of human pathological tissues, interventional studies, clinical outcome measurements, and interdisciplinary investigations of human disease. The services provided will integrate with other RDRCC Cores and Rheumatology Disease centers. This Core will interface with other resources at Johns Hopkins to provide additional consultation and training for investigators.