CCTS 2.0 Vision and Scope

From CTMS_WIKI

Vision

The caBIG Clinical Trials Suite (CCTS) is an enterprise clinical trials system designed to facilitate clinical workflows and data sharing in single and multi-site settings. It makes it easier to support clinical research by providing a bundled set of core clinical trials applications, reduces the burden of data entry by sharing data amongst IT modules that support clinical research, and facilitates clinical care and research by streamlining user workflows across applications.

Being designed primarily for use in trial sites, the suite is comprised of a collection of interoperable modules covering a broad range of key areas in cancer clinical trials management. These include:

• Protocol, person, and organization management via COPPA
• Subject registration via C3PR
• Patient scheduling via PSC
• Adverse events reporting via caAERS
• Lab analysis via LabViewer
• Clinical data management via C3D

These products are integrated through a messaging infrastructure choreographed by caXchange. The service-oriented nature of the architecture and detailed interface/data/semantic specifications make it possible to plugin external systems to replace an existing component or participate in the messaging. Data is shared amongst these modules within institutional boundaries to facilitate clinical workflows and is shared across sites to facilitate multi-site trial workflows. Messaging is based upon the caGrid infrastructure, leveraging GAARDS to provide a robust security infrastructure.

The products are integrated not only through data sharing, but also through a portal that integrates the web applications. This further facilitates clinical workflows by providing cross-application views of data and reports, as well as allowing users to seamlessly move between the applications.

The suite can be deployed all or in part locally, as well as leveraged centrally at NCI or another coordinating center. Users and organizations are able to securely access studies, subject, and other data that fall within their organization's purview.

Scope

CCTS 2.0 will implement the following features:

Service-oriented Architecture

• Service-oriented Architecture: CCTS will follow a service-oriented architecture paradigm whereby data exchanged between components will flow through well structured, semantically annotated services. Components will be identified as being the source of truth for particular data entities, and each other component will accept data creation and updates only from the source of truth. The data entities will minimally include Research Staff and Investigators (Persons), Organizations, Studies, Patients/Subjects, Registrations, and Labs. As use cases arise, new data entities and sources of truth must be identified and implemented.

• Integration with COPPA Services: CCTS will integrate with the COPPA services for creation and updating of Studies, Research Staff, Investigators, and Organizations.

Security

• Centralized Security Architecture: CCTS will provide for central provisioning of users and their roles such that once provisioned centrally, they need not be provisioned within components again. CCTS will also continue to leverage the caGrid infrastructure for trust, authentication, authorization, delegation, and single sign-on. The NCI production grid will be used for Dorian, CDS, and GTS.

• Central User Interface for Managing Users and Roles: CCTS will provide a centralized web application that plugs into the portal that will handle the managing of users (create, update, remove) and their roles. This user interface will be intuitive for CCTS functionality - that is it will manage users and roles across organizations and studies.

• Hosted Environment Mode: CCTS will function in a shared or dedicated hosted mode such that users from different organizations can login to CCTS and perform clinical activities. These activities must be performed in a secure manner. Users from different organizations should not be able to see or update data from those of other organizations unless specifically determined by use cases. In addition, multi-site trials should accordingly be implemented such that the clinical workflows for coordinating, participating, and other organizations are appropriately implemented. Note: this does not include validation and independent, 3rd party auditing of proposed hosted solution

• Add authorization to grid services: CCTS will support the appropriate user authorization at all public interfaces, including grid service.

• Definition and Implementation of Legal Security Requirements: the CCTS team will work with the legal security working group to define a set of legal security requirements and then will implement them.

Portal

• Portal: CCTS will provide a portal solution for wrapping the components into a single web application. The Portal will provide a central point to login (through WebSSO) and a cross-application dashboard to display cross-application views of data. Furthermore, the Portal will allow for users to navigate across applications in a seamless way.

• Ad-hoc Reporting: CCTS will enable cross-application ad-hoc reporting through a 3rd-party module (e.g. JReport). Example reports should be provided.

Functionality

• New interoperability Use Cases: CCTS will continue to engage subject matter experts and implement new cross-component functionality. Whenever new use cases are implemented, they will follow the CCTS 2.0 Vision and Scope (e.g. the implementation will follow the SOA approach, security approach, etc.).

• New features in modules via inclusion of latest application releases: CCTS functionality will be prioritized over new application features that do not contribute to the goals laid out in the CCTS 2.0 Vision and Scope. However, as resources allow, projects teams will continue developing new application functionality that will be rolled into CCTS and be considered core to CCTS adoption.

Infrastructure

• Improved Auditing and Error Handling Framework: CCTS will have business and technical errors appropriately thrown, coded (i.e. with a coding system), documented, passed through the middleware, logged, and handled by the applications.

• Enhanced Transaction Control: CCTS will refactor the current transaction control to leverage appropriate pessimistic or optimistic transaction control with as much configurability as possible and appropriate.

• Reduction of Impact of Local Grid Deployment and Administration: CCTS will leverage the NCI production grid to minimize the installation and configuration grid components locally. Organizations must still have the option to manage security (and other grid functions) locally, as well as keep the instances of their components within their firewall.

• Single database with multiple schemas: CCTS will be optionally deployable into a single database instance with multiple schemas (i.e. one for each component). This is to minimally include the CTMS applications and need not include other, cursory components such as caGrid components.

• Continuous Integration: CCTS will provide a common continuous integration environment to perform unit and integration tests automatically. This system will in an automated way build and test each component, deploy each component, and test the interoperability of each component.

• Upgrade to caGrid 1.3: CCTS will upgrade to caGrid 1.3 in order to stay current with the CBIIT and caBIG technology stack. This will involve integration with the caGrid 1.3 production grid at NCI.

Semantics

• Harmonized with BRIDG 2.1: each component in CCTS will have their domain and implementation models harmonized with BRIDG 2.1, and all messages exchanged between applications will be BRIDG 2.1 harmonized. This includes harmonizing the with structure, semantics, and datatypes of BRIDG 2.1.

Outreach

• Cross-domain Hotlinking: CCTS will provide the functionality for hotlinking from CCTS applications to tissue banking and imaging application through the use of common identifiers. These hotlinks should be placed at appropriate places within the applications per cross-domain use cases.

• Integration with CDMS systems: CCTS will integrate with C3D, OpenClinica, and other CDMSes through the use of general CDMS interfaces (connectors).

• Packaging CCTS with an Open Source CDMS: CCTS will optionally be bundled with OpenClinica for integration with an open source CDMS. This should include all integration functionality that C3D and other applications support (e.g. create study, register subject, load labs, etc.).

• Browser Support: CCTS will continue to support the latest web browsers, which includes Internet Explorer 8 and Firefox 3.

• Adoption Support: CCTS will continue to support the adoption efforts of the community by answering technical questions related to suite installation, functionality, and customization.

• Validation/Certification by 3rd party auditors: in order to comply with FDA and other federal regulations, CCTS should undergo a 3rd party validation/certification process.