caBIG Enterprise

caBIG企业

• 批准号: 7593002
• 负责人: Kenneth H Buetow
• 金额: $ 821.66万
• 依托单位: DIVISION OF BASIC SCIENCES - 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/7593002
• 关键词: Academia; Administrator; Adoption; Advisory Committees; Animals; Architecture; Class; Clinical; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Clinical trial protocol document; Code; Communities; Complement 3d; Credentialing; Data; Data Sources; Databases; Development; Drops; Electronics; End Date; End Point; Generic Drugs; Goals; Government; Health Status; Healthcare; Industry; Information Systems; Investments; Java; Malignant Neoplasms; Maps; Mission; Modeling; Online Systems; Organ; Outcome; Paper; Participant; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Process; Protocols documentation; Registries; Regulation; Reporting; Reproduction spores; Research; Research Activity; Research Infrastructure; Research Personnel; Resources; Secure; Semantics; Series; Services; Site; Software Tools; Speed; Standards of Weights and Measures; Structure; System; Terminology; Time; Title; Toxic effect; Translational Research; Treatment Protocols; United States Food and Drug Administration; Update; Validation; Vision; Vocabulary; Work; abstracting; anticancer research; authority; base; biomedical informatics; cancer Biomedical Informatics Grid; cost; data management; data modeling; digital; information gathering; interoperability; member; microbial alkaline proteinase inhibitor; oncology; performance site; programs; prototype; repository; special interest group; tool; tool development; transmission process

The first enterprise effort was undertaken under the auspices of the Interagency Oncology Task Force (IOTF) partnership between the NCI and FDA. A key component of IOTF is the development of common biomedical informatics platforms with the FDA which support regulatory submissions. The efforts represent an enterprise infrastructure called the. CRIX is a collaborative effort among government, industry and academia to implement a common, standards based electronic infrastructure for regulatory data and document submission to and review by regulatory authorities. CRIX is creating an infrastructure for regulatory data and document management services with the goal of speeding new research discoveries to the public. This vision is to build an infrastructure that: Allows secure transmission of clinical research information between sponsors, researchers, and regulatory authorities; Facilitates the adoption of electronic data standards, standardized terminologies, e-transactions, and e-submissions; Reduces the overall cost, both financial and time investment, of information gathering and submissions development processes as well as review and analysis of information Is accessible to all Development is occurring through an open community process involving academia, government, and industry and is leveraging NCIs caCORE and caBIG infrastructure development, tools and capabilities. The projects are being piloted with NCI and FDA, expanding in later phases to develop the community requirements and perform operational pilots the non-government community. There are currently three CRIX development projects: Firebird/SAFE Global Investigator Registry for commonly used/referenced data: Firebird automates the existing FDA Form 1572 registration process and enable investigators to register online with NCI and other sponsors, including pharmaceutical companies, thus removing paper based latencies and infrastructure costs and allowing investigators to centrally maintain and manage all their 1572 registrations. Through a single web-based platform, investigators will be able to maintain a secure profile of the most common information required when registering to participate in trials. Legally enforceable digital signatures compliant with Title 21 Regulations: FIREBIRD is being built as an open platform that will be able to accept most forms of legally enforceable digital signature applications with minimal configuration through a set of open APIs. SAFE will bridge to the federal DHHS credentialing service. CRIX Clinical Data Repository (CDR) Also called the Janus project, which is a collaborative effort with NCI, FDA and CRIX to develop a sustainable, secure and standards-based repository for electronic IND submissions of structured clinical data, protocols, analysis plans, animal toxicity data, etc. A tools layer built on top of the repository allows for easy analysis and reporting of submitted clinical trial data The pilot is based on the Janus data model, populated with Study Data Tabulation Model (SDTM) data, and accessible via BRIDG. SDTM and BRIDG are collaborative efforts with the cancer community, CDISC, NCI and FDA to standardize data submission in clinical research. The CRIX development efforts inform the Clinical Trials Working Group efforts to support NCI-specific Clinical Trials research activities. Clinical Protocols Portal The caBIG Clinical Protocols Portal is a web based application that allows researchers to share their clinical trial protocols among members of the caBIG community. In addition, the system collects data related to the trial including Primary Sites, Participating Sites, Endpoints, Start/End Dates, Accruals, Type, Phase, Organ site, Study medications, and Regimen. Users can then retrieve information about specific trials by searching the system for clinical trials based on various criteria including title and description keywords, phase, and performance site. Submitters may elect to allow other researchers to download their Protocol Document, or may choose to keep it private. Submitters and Administrators also have the ability to update and edit the information about the trial, including the accruals, as needed. Clinical Trials Object Model (CTOM) The Clinical Trials Object Model (CTOM) is a key component of the CBIIT Clinical Trials Infrastructure and is a part of the effort to model the clinical trials domain and provide patient de-identified clinical trials data to the cancer research community. CTOM, which is represented as a UML class diagram, provides a set of common generic classes representing the clinical trials domain which can be used to model data from any Clinical Trial Data Management System (CDMS) or other data source. CTOM has been developed using Enterprise Architect and the clinical trials data will be available via Java APIs, much like the CBIITs existing caBIO Java objects. CTOM is a reference implementation of the BRIDG model and the classes identified in CTOM are concrete instantiations of the abstract BRIDG classes. The intent of CTOM is to implement java APIs for legacy data systems to act as standardized nodes on the grid. A grid user can then use CTOM APIs to perform queries across all nodes. This allows for more efficient and more comprehensive data sharing based on standard objects . At present, CTOM is a reference implementation of only the Study Execution phase of BRIDG and is focused on a set of use cases for outcomes related queries. This will change as BRIDG evolves and matures and additional use cases for CTOM are identified. The first prototype data source is CBIITs C3D clinical trials data repository. caAdaptor The goal of caAdapter effort is to develop standards-based infrastructure components supporting interoperability across clinical trials data. Specifically, this involves providing software tools and frameworks supporting: The implementation of Health Level Seven (HL7) v3 messaging in clinical trials applications The mapping of existing clinical trials data to the HL7 v3 standard in support of semantic interoperability in clinical healthcare and translational research The implementation of clinical trials infrastructure components leveraged by NCI and the participants of the cancer Biomedical Informatics Grid (caBIG) program caAdapter has a component based architecture that offers a tool set to support these efforts. It has 2 major components the Core Engine and the Mapping Tool. The Core Engine is built on top of the HL7's Java Special Interest Group (Java SIG) code base. It provides a Java based API to HL7 v3 components, such as RIM classes, HL7 data type classes and HL7 Meta Data classes. In addition, it contains a utility package to support HL7 v3 message building and parsing. It also provides additional services of vocabulary validation of the HL7 structural attributes by integrating with the CBIIT's Enterprise Vocabulary Services (EVS). The Mapping Tool component has a GUI based front-end application for mapping clinical data to HL7 version 3 specification(s). It has a drag-and-drop interface and also provides some data transformation functions. The caAdapter supports caBIGs mission of developing a translational research infrastructure and building a clinical research network by providing a common platform for sharing data.

第一次企业努力是根据NCI和FDA之间的机构间肿瘤学工作组（IOTF）伙伴关系的主持人进行的。 IoTF的关键组成部分是通过FDA的开发常见的生物医学信息学平台，该平台支持监管提交。 这些努力代表了企业基础架构称为The。 CRIX是政府，行业和学术界之间的合作努力，以实施基于标准的电子基础设施，以进行监管数据，并由监管机构提交和审查文件。 CRIX正在创建用于监管数据和文档管理服务的基础架构，目的是向公众加速新的研究发现。这个愿景是建立一个基础设施： 允许在赞助商，研究人员和监管机构之间安全传输临床研究信息； 促进了采用电子数据标准，标准化术语，电子过渡和电子释放； 降低信息收集和提交开发过程的整体成本，包括财务和时间投资，以及审查和分析信息 所有人都可以访问 发展是通过涉及学术界，政府和行业的开放社区流程进行的，并利用NCIS Cacore和Cabig基础设施开发，工具和能力。这些项目正在使用NCI和FDA进行试验，并在以后的阶段扩展，以发展社区要求并执行非政府社区的运营飞行员。目前有三个CRIX开发项目： 火鸟/安全 全球研究者注册表的常用/参考数据：Firebird自动化现有的FDA表格1572注册过程，并使研究人员能够在NCI和其他赞助商（包括制药公司）在线注册，从而删除基于纸张的潜伏期和基础设施成本，并允许研究人员在中心维护和管理其1572个注册。通过一个基于Web的平台，调查人员将能够保留注册参加试验所需的最常见信息的安全概况。 合法可执行的数字签名符合标题21规定：Firebird是一个开放平台，它将能够通过一组开放的API接受大多数形式的合法可执行的可执行数字签名应用程序，并以最小的配置。 Safe Will Will将桥梁到联邦DHHS凭证服务。 CRIX临床数据存储库（CDR） 也称为Janus Project，这是与NCI，FDA和CRIX的合作努力，以开发可持续，安全且基于标准的基于标准的存储库，用于对结构化临床数据，协议，分析计划，动物毒性数据等进行电子IND提交。 在存储库之上构建的工具层可以轻松分析和报告提交的临床试验数据 飞行员基于Janus数据模型，该模型填充了研究数据制表模型（SDTM）数据，并可以通过BRIDG访问。 SDTM和BRIDG是与癌症社区，CDISC，NCI和FDA的合作努力，以在临床研究中标准化数据提交。 CRIX开发工作为临床试验工作组提供了支持，以支持NCI特定的临床试验研究活动。 临床方案门户 Cabig临床协议门户网站是一个基于Web的应用程序，可让研究人员在Cabig社区成员之间共享其临床试验方案。此外，该系统还收集与试验有关的数据，包括主要站点，参与站点，端点，开始/结束日期，应计，类型，相位，器官，器官，研究药物和方案。然后，用户可以通过根据各种标准搜索系统进行临床试验来检索有关特定试验的信息，包括标题和描述关键字，阶段和性能站点。提交者可以选择允许其他研究人员下载其协议文档，或者可以选择将其私有化。提交者和管理员还可以根据需要更新和编辑有关试验的信息，包括应计。 临床试验对象模型（CTOM） 临床试验对象模型（CTOM）是CBIIT临床试验基础设施的关键组成部分，并且是对临床试验领域进行建模并为癌症研究社区提供去识别的临床试验数据的努力的一部分。 CTOM表示为UML类图，提供了一组代表临床试验域的常见通用类，可用于模拟任何临床试验数据管理系统（CDMS）或其他数据源的数据。 CTOM是使用企业建筑师开发的，临床试验数据将通过Java API获得，就像CBIITS现有的Cabio Java对象一样。 CTOM是BRIDG模型的参考实现，CTOM中标识的类是抽象BRIDG类的具体实例。 CTOM的目的是实现Java API，以使旧数据系统充当网格的标准化节点。然后，网格用户可以使用CTOM API在所有节点上执行查询。这允许根据标准对象进行更有效，更全面的数据共享。 目前，CTOM是BRIDG的研究执行阶段的参考实现，并专注于与结果相关查询的一组用例。随着Bridg的发展和成熟以及确定CTOM的其他用例，这将发生变化。 第一个原型数据源是CBIITS C3D临床试验数据存储库。 Caadaptor CAAdapter努力的目的是开发基于标准的基础设施组件，以支持临床试验数据中的互操作性。 具体而言，这涉及提供支持的软件工具和框架： 在临床试验申请中，健康级别七（HL7）V3消息传递的实施 现有的临床试验数据映射到HL7 V3标准，以支持临床医疗保健和转化研究中的语义互操作性 NCI利用临床试验基础设施组件和癌症生物医学信息学网格（CABIG）计划的实施 CAADAPTER具有基于组件的体系结构，该体系结构提供了一个工具集来支持这些工作。它具有2个主要组件的核心引擎和映射工具。 核心引擎建立在HL7的Java特殊兴趣组（Java Sig）代码基础上。它为HL7 V3组件提供了基于Java的API，例如RIM类，HL7数据类型类和HL7 META数据类。此外，它还包含一个实用程序包，以支持HL7 V3消息构建和解析。它还通过与CBIIT的企业词汇服务（EVS）集成来提供HL7结构属性词汇验证的其他服务。 映射工具组件具有基于GUI的前端应用程序，用于将临床数据映射到HL7版本3规范。它具有拖放接口，还提供了一些数据转换功能。 CAAdapter支持Cabigs的使命，即通过提供共享数据的共同平台来开发转化研究基础架构并建立临床研究网络。