caBIG Enterprise

caBIG企业

• 批准号: 8158470
• 负责人: Kenneth Buetow
• 金额: $ 81.93万
• 依托单位: OFFICE OF THE DIRECTOR, NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8158470
• 关键词: Adopted; Agreement; Architecture; Area; Biological Sciences; Biomedical Research; Cancer Center; Capital; Case Report Form; Clinical Trials; Collaborations; Common Data Element; Communities; Community Developments; Complement 3d; Computer software; Conduct Clinical Trials; Consensus; Contractor; Credentialing; Data; Data Reporting; Data Set; Databases; Development; Documentation; Funding; Goals; Image; Industry; Informatics; Information Systems; Information Technology; Institution; Joints; Knowledge; Legal; Libraries; London; Maintenance; Methods; Modeling; Monitor; Pathology; Penetration; Phase; Policies; Process; Provider; Reporting; Research Infrastructure; Research Institute; Research Personnel; Security; Services; Site; Solutions; Source; Strategic Planning; System; Technology; Tissue Banking; Tissue Banks; Training; Translational Research; Vocabulary; Work; anticancer research; biological research; caGrid; cancer Biomedical Informatics Grid; design; genome wide association study; image archival system; imaging informatics; in vivo; interoperability; programs; repository; software development; software systems; special interest group; symposium; tool; working group

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

社区发展活动： 四个领域的活动（综合癌症研究、临床试验管理系统、体内成像、组织库和病理学工具）、两个跨领域架构和词汇/通用数据元素（VCDE）工作空间以及三个战略工作组（战略规划、文件编制和培训，以及数据共享和知识资本）在企业阶段继续进行，癌症研究界更广泛地参与其中。这些活动对于维护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计划继续开发与caBIG兼容的基础设施和以用户为中心的软件开发工具。2008财政年度，在软件开发方面启动了两项重大进展： 临床试验互操作性框架：该软件系统捆绑包利用现有的caBIG兼容应用程序（C3 D、C3 PR、caAERS、caXchange、CTODS、PSC和caGrid框架）创建一个可互操作的系统，用于管理临床试验的开展。该系统被设计为模块化的，因此特定的功能可以被癌症中心和合作团体现有的系统所取代。发布的目标日期为2008财年中期 Life Sciences Distribution：该软件包旨在为基础生物医学研究提供一套预打包的工具。该软件包包含caArray（微阵列存储库）、caTissue（组织库工具）、NCIA（DICOM图像存档）、CTODS（临床试验存储库）和caGWAS（全基因组协会研究数据集市）。该捆绑包旨在利用一组通用的底层技术，并具有足够的模块化，可以部署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财政年度，科技工作组的四项信息学举措得到认真实施。这些倡议是： 开发一个数据库，作为所有NCI申办的临床试验报告和信息共享的中心数据来源。提交数据库的数据将通过统一的网络界面或门户网站提供给所有适当确定的用户。 制定和实施一项计划，使所有NCI支持的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癌症研究界无缝共享标准化信息。 通过利益相关者共识（包括行业和FDA），建立统一和标准化的II期和III期病例报告表（CRF）核心库，纳入通用数据元素（CDE）。 NCI、NCI申办的机构和行业接受的安全存储库，作为研究者和临床试验中心进行临床试验所需的所有和当前凭证的单一存储库。 为了开始实施，在caBIG中成立了四个特别兴趣小组。第一个目标是报告/共享SIG的职责，第二个目标是互操作性SIG的职责，第三个目标是研究实施SIG的职责，第四个目标是规划/监测SIG的职责。成立了一个由外部专家组成的CTMS指导委员会，就与CTWG实施有关的活动向主承包商提供建议。报告/共享SIG已开始收集临床试验数据库（CTDB）的要求，研究实施SIG已开始第一个CRF模块的工作。 数据共享和知识资本： DSIC工作空间继续努力创建一套数据共享工具（在此为示范协定、政策文件等）。以实现各种敏感度的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销和临床试验互操作性框架一起发布。这个捆绑包，数据共享和安全框架（DSSF）将与其他caBIG产品打包，以提供法律的和政策框架，从而实现大规模的数据共享和互操作性。 安全性： caBIG企业计划已经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。这个小组已经采用了一组临时安全策略，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计划已经启动了企业支持网络（ESN），该网络将为caBIG过渡到更广泛的网络提供可扩展的支持解决方案。最终，ESN将由一系列NCI资助的知识中心和项目办公室以及NCI认可的（但不是资助的）支持服务提供商组成。该网络的最初活动是创建caBIG青铜兼容性过程，允许非caBIG开发的软件被认证为青铜兼容