caBIG Enterprise

社区发展活动： 四个领域的工作空间(综合癌症研究、临床试验管理系统、活体成像、组织库和病理学工具)、两个交叉架构和词汇/公共数据元素(VCDE)工作空间以及三个战略工作组(战略规划、文件和培训、数据共享和智力资本)在企业阶段继续开展活动，癌症研究界有更广泛的参与。这些活动对于维持一个支持数据共享的社区至关重要，并为确定癌症研究社区的信息技术和标准需求提供了一个重要机制。 与英国国家癌症研究所的合作继续进行，并在英国伦敦举行的联合会议上正式启动。此外，还启动了几个初步项目，包括美国和英国研究人员在成像信息学领域的合作。 软件开发活动： CaBIG方案继续开发与caBIG兼容的基础设施和以用户为中心的软件开发工具。2008财年在软件开发方面启动了两项重大发展： 临床试验互操作框架：这套软件系统利用现有的caBIG兼容应用程序(C3D、c3PR、caAERS、caXchange、CTods、PSC和caGrid框架)来创建管理临床试验进行的可互操作系统。该系统被设计成模块化的，这样特定的功能部分可以被癌症中心和合作小组已经存在的现有系统取代。目标发布日期为2008财年年中 生命科学分发：这个软件捆绑包旨在为进行基础生物医学研究提供一套预先打包的工具。该捆绑包包含caArray(微阵列储存库)、caTIssue(组织库工具)、NCIA(DICOM图像档案)、CTods(临床试验储存库)和caGwas(基因组广域协会研究数据集市)。该捆绑包旨在利用一组通用的底层技术，并且足够模块化，可以部署这五个组件的任何组合。预计部署日期为2008年2月。 临床试验工作组(CTWG)实施： 在2008财年期间，反恐工作组的四项信息学倡议开始认真执行。这些措施包括： 开发一个数据库，作为所有NCI赞助的临床试验的报告和信息共享的中心数据来源。向数据库提交的数据将通过统一的、基于网络的界面或门户向所有适当识别的用户提供。 制定和实施一项计划，使NCI支持的所有内部和外部临床试验系统能够以与NCI caBIG完全互操作的方式在NCI癌症研究社区无缝共享标准化信息。 通过利益攸关方协商一致(包括业界和食品和药物管理局)，建立统一和标准化的第二阶段和第三阶段病例报告表(CRF)核心图书馆，纳入共同数据要素(CDE)。 NCI、NCI赞助的机构和行业接受的安全储存库，作为一个单一储存库，存储所有研究人员和临床试验站点进行临床试验所需的和当前的凭据。 为了开始实施，在caBIG中设立了四个特别利益小组。第一个目标是报告/共享SIG的责任，第二个目标是互操作性SIG的责任，第三个目标是研究行为SIG的责任，第四个目标是规划/监测SIG的责任。设立了一个由外部专家组成的CTMS指导委员会，就与执行CTWG有关的活动向主承包商提供咨询。报告/共享SIG已经开始收集临床试验数据库(CTDB)的要求，研究行为SIG已经开始第一个CRF模块的工作。 数据共享和智力资本： DSIC工作区继续努力创建一套数据共享工具(在本例中为模型协议、政策文档等)。以实现各种程度的敏感数据的安全数据共享。主要的新活动是启动一个捆绑包，该捆绑包将与生命科学分发和临床试验互操作性框架一起发布。该捆绑包即数据共享和安全框架(DSSF)将与其他caBIG产品打包在一起，以提供实现大规模数据共享和互操作性的法律和政策框架。 安全： CaBIG企业计划创建了一个联合工作组(在DSIC和架构工作区之间)来处理安全策略问题。该小组已经采用了一套临时安全策略，目前正在创建caGrid将在企业阶段使用的策略。 企业支持网络： CaBIG计划启动了企业支持网络(ESN)，该网络将在caBIG过渡到更广泛的网络时为其提供可扩展的支持解决方案。最终，ESN将由一组NCI资助的知识中心和计划办公室以及NCI认可(但未资助)的支持服务提供商组成。该网络最初的活动是创建caBIG青铜兼容流程，该流程允许非caBIG开发的软件被认证为与青铜兼容

Community development activities: The activities of the four domain workspaces (Integrative Cancer Research, Clinical Trials Management Systems, in vivo Imaging, and Tissue Banks and Pathology Tools), the two cross-cutting Architecture and Vocabulary/Common Data Elements (VCDE) workspaces and the three strategic workgroups (Strategic Planning, Documentation and Training, and Data Sharing and Intellectual Capital) have continued in the Enterprise phase with broader participation from the cancer research community. These activities are essential to the maintenance of a community that supports data sharing, and provides an important mechanism for ascertaining the information technology and standards needs of the cancer research community. The collaboration with the UK National Cancer Research Institute continued with a formal launch at a joint conference in London, UK. In addition, several initial projects have been launched, including a collaboration between US and UK researchers in the area of imaging informatics. Software Development Activities: The caBIG program has continued the development of caBIG compatible infrastructure and user centered software development tools. Two significant developments were initiated during FY2008 with regard to software development: Clinical Trials Interoperability Framework: This bundle of software systems utilizes existing caBIG compatible applications (C3D, C3PR, caAERS, caXchange, CTODS, PSC and the caGrid framework) to create an interoperable system for managing the conduct of clinical trials. The system is designed to be modular, so that particular pieces of functionality can be replaced by existing systems already present at cancer centers and cooperative groups. The target date for release is the middle of FY2008 Life Sciences Distribution: This bundle of software is designed to provide a pre-packaged suite of tools for the conduct of basic biomedical research. This bundle contains caArray (microarray repository), caTissue (tissue banking tool), NCIA (DICOM image archive), CTODS (clinical trials repository) and caGWAS (Genome Wide Association Study data mart). The bundle is designed to utilize a common set of underlying technology and to be modular enough to deploy any combination of the five components. Expected deployment date is Feb 2008. Clinical Trials Working Group (CTWG) Implementation: During FY2008, the implementation of the four informatics initiatives of the CTWG were begun in earnest. These initiatives are: Development of a database to serve as a central source of data for reporting and information sharing on all NCI-sponsored clinical trials. Data submitted to the database will be available to all properly identified users through a unified, web-based interface or portal. Development and implementation of a plan that will enable all NCI-supported internal and external clinical trials systems to seamlessly share standardized information across the NCI cancer research community in a manner that is fully interoperable with NCIs caBIG. Establishment of a core library of harmonized and standardized Phase II and III Case Report Forms (CRFs), incorporating Common Data Elements (CDEs), through stakeholder consensus (including industry and FDA). A secure repository that is accepted by NCI, NCI-sponsored institutions and industry as a single repository for all required and current credentials for investigators and clinical trial sites to conduct clinical trials. In order to begin implementation, four Special Interest Groups or SIGs were created in caBIG. The first goal is the responsibility of the Reporting/Sharing SIG, the second of the Interoperability SIG, the third of the Study Conduct SIG and the fourth the responsibility of the Planning/Monitoring SIG. A CTMS Steering Committee composed of outside experts was created to advise the prime contractor on activities related to the CTWG implementation. The Reporting/Sharing SIG has begun to collect requirements for the clinical trials data base (CTDB) and the Study Conduct SIG has begun work on the first CRF module. Data Sharing and Intellectual Capital: The DSIC workspace has continued its efforts to create a set of data sharing tools (in this case model agreements, policy documents, etc.) to enable secure data sharing of data of a variety of degrees of sensitivity. The major new activity was the initiation of a bundle that will be released with the Life Sciences Distribution and Clinical Trials Interoperability Framework. This bundle, the Data Sharing and Security Framework (DSSF) will be packaged with other caBIG offerings to provide the legal and policy framework to enable data sharing and interoperability on a large scale. Security: The caBIG Enterprise program has created a joint working group (between the DSIC and Architecture Workspaces) to deal with questions of security policy. This group has adopted a set of interim security policies and is currently engaged in creating the policies that caGrid will use during the Enterprise phase. Enterprise Support Network: The caBIG program has launched the Enterprise Support Network (ESN) that will provide a scalable support solution for caBIG as it transitions to the wider network. Ultimately, the ESN will comprise a set of NCI funded Knowledge Centers and Program Offices as well as NCI recognized (but not funded) support service providers. The initial activity of this network was the creation of the caBIG Bronze Compatibility Process that allowed non-caBIG developed software to be certified as Bronze Compatible