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.
