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Clinical Trials Management Systems (CTMS) Newcomer Information
Mission and Goals
I. Background
The cancer Biomedical Informatics Grid (caBIG®) initiative, overseen by the National Institute of Health’s (NIH) Center for Biomedical Informatics and Information Technology (CBIIT), was conceived to connect the cancer research and clinical community through open, interoperable technology that facilitates data sharing and collaboration, speeding the translation of discoveries from research to clinical care. Since its inception in 2004, caBIG® has successfully launched innovative tools; infrastructure and policy resources that enable individuals and organizations in the cancer community and beyond to move further down the path to realizing personalized medicine. The ultimate goal is to speed the delivery of innovative approaches for the prevention and treatment of cancer; however, the infrastructure and products of caBIG® are widely applicable outside the cancer and research communities. Over 1,000 individuals from more than 190 organizations are participating at the time of writing.
In 2008-2009, caBIG® has focused heavily on deploying compatible technology (based on the caBIG® developed caGrid infrastructure) to NCI sponsored cancer centers and other organizations. This has resulted in the creation of an interoperable grid with more than 100 services that provide data and/or analysis to the cancer research community. In addition to the benefits that accrue to the community at large, it has given CBIIT real-world experience in deploying large networks, has identified both the strong and weak points of the caGrid infrastructure, and has created a group of individuals in the cancer research community that are now experienced with and comfortable with the deployment of caBIG® compatible technology (specifically at the majority of NCI-designated cancer centers).
To accomplish its work, caBIG® has organized into workspaces, virtual teams that develop technologies in specific areas of interest. The workspaces serve as self-sustaining communities of partners in which tools and ideas are continually being developed, shared, and improved. The Clinical Trials Management Systems (CTMS) is one of those workspaces.
II. Mission
The ultimate goal of caBIG® is to speed the delivery of innovative approaches for the prevention and treatment of cancer; however, the infrastructure and products of caBIG® are widely applicable outside the cancer and research communities.
In service of this greater mission, the mission of the CTMS workspace is to deliver to the clinical research and care communities the ability to securely gather, exchange, explore, integrate, and reuse data and information within and among disciplines by:
- Supplying stewardship, convening the diverse communities of stakeholders participating in the evolution of caBIG®’s clinical portfolio and coordinating their activities within a fabric of shared purpose.
- Identifying gaps and unmet needs in existing standards, and collaborating with communities to curate and extend these standards, vocabularies, models, and architectures to exchange and integrate clinical data across heterogeneous domains.
- Acting as trusted facilitator for potential software development projects, coalescing and managing requirements for, and supporting the development and use of, software tools and infrastructure that adhere to established standards and models and address key gaps, enhancements, and unmet needs.
- Facilitating the broad availability of structured, interoperable clinical content by coordinating, documenting and following processes, policies and best practices to provide assurance of data provenance and interoperability within appropriate social, legal, ethical and security contexts.
- Fostering a culture of collaboration and sharing.
III. Vision
The vision of the CTMS Workspace is that caBIG® become the means by which the research and care communities gather, exchange, explore, integrate, and reuse clinical data and information to extend healthy life and reduce the burdens of illness and disability.
IV. How the CTMS Workspace Operates
The CTMS Workspace welcomes community participation from individuals and groups interested in the workspace mission and goals. Participant activities include attending regular teleconferences and periodic face-to-face meetings, commenting on products under development or review and conducting more in-depth work in pursuit of the CTMS Workspace objectives. Anyone with an interest in the activities of the CTMS Workspace is welcome to attend teleconferences and sign up for the listserv.
If you are interested in learning more you can join the next teleconference or contact the CTMS Workspace Lead or any of the project coordinators. The CTMS Contact Information section will provide you with their contact information.
Teleconferences: In addition to developing the caBIG Clinical Trials Suite, workspace participants meet regularly via teleconference to discuss issues and devise solutions. The CTMS Workspace has four regular monthly phone calls that allow community members and other interested parties to receive updates, provide input and discuss the ongoing work of the CTMS program. As you will see from the descriptions below each call has a different focus and purpose in an effort to avoid duplication of information and to encourage in-depth discussions. Each call is 90 minutes long and are open to the general public. The details for each call are listed below and can also be located on the Schedule . To see what the CTMS Workspace has been working on recently, you can also review the Meeting Notes from past teleconferences.
The monthly calls are as follows:
CTMS Bi-Monthly Workspace Call
(2nd and 4th Tuesday of every month from 12:00 - 1:30 pm EST)
Teleconference Information: Dial in: 888-748-4891 Passcode: 99353
Adobe Connect Information: URL: http://cbiit.acrobat.com/ctmscalls
This call will provide community members updates on the CTMS workspace as a whole including items such as its goals, mission, and objectives. This call will also cover overarching items such as NCI mandates, the caBIG annual meeting, interactions with the FDA, and the caBIG CDMS program. The final 30 minutes of this call will always be devoted to an "open forum" discussion where community members may ask questions, make comments or provide feedback regarding the CTMS workspace and its efforts.
CTMS Knowledge Center: The CTMS Knowledge Center provides a centralized, authoritative repository of knowledge, information, and web-based support to facilitate the deployment and ongoing development of caBIG ® tools, standards, and infrastructure in the CTMS domain. Key services provided by the Knowledge Center include:
- Providing domain expertise related to clinical trials management systems
- Posting up-to-date installation packages for CTMS tools
- Maintaining technical and end-user documentation
- Fostering open source development of caBIG ® tools by the community
- Collecting and monitoring defect reports, feature requests, and end-user requirements
Listserv: Between teleconferences the CTMS mailing list is the primary means of collaboration for participants. Discussions, teleconference agendas and dial-in information as well as cancellations are sent out on the mailing list, so signing up is a good way to keep up-to-date. Anyone with an interest in the activities of the CTMS Workspace is welcome to attend teleconferences and sign up for the mailing list.
Face-to-Face Meetings: In addition to the teleconferences, the CTMS Workspace gathers for face-to-face meetings periodically over the course of the year. These meetings provide the opportunity for members to tackle specific issues that are best accomplished together in real time, receive updates, and discuss accomplishments, upcoming tasks and future goals. These are announced in What's BIG This Week and distributed through the caBIG ® Announce mailing list . To see what has been discussed at previous CTMS face-to-face meetings, click here .
V. Achievements and Activities
Tools
The Clinical Trials Management Systems (CTMS) Workspace of caBIG® has developed, and is continuing to develop, modular, interoperable and standards-based software tools, known as the “caBIG® Clinical Trials Suite”, which are designed to meet diverse clinical trials management needs. The tools developed are configurable to meet the needs of trial sites with little or no clinical data management systems in place as well as those with robust systems, and take into account the diversity of clinical research activities and local practices that exist among trial sites
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 clinical trials management. These include:
- Study participant registration (via C3PR)
- Patient scheduling (via PSC)
- Adverse event management and reporting (via caAERS)
- Exchange of clinical laboratory data and other clinical data (via and LabViewer)
- Protocol, person, and organization management (via NCI Enterprise Services)
- Integration with clinical data management systems (via a series of Connectors)
These tools enable management of tasks such as: screening and registering patients for accrual to clinical trials; scheduling and tracking of patient activities during the course of a study; integrating laboratory results with the patient record; tracking and managing adverse events; capturing, storing, analyzing and routing clinical data in a meaningful manner.
These products are integrated through an enterprise service bus messaging infrastructure choreographed by caBIG Integration Hub (formerly caXchange), a configurable hub for exchanging clinical trial information between applications and systems. caBIG Integration Hub (formerly caXchange) also provides the Suite with the ability to exchange clinical trials information in an audited and controlled manner. Data are shared amongst the 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 Grid Authentication and Authorization with Reliably Distributed Services (GAARDS) to provide a robust security infrastructure.
The Suite components are:
caBIG Integration Hub (formerly caXchange)
The Cancer Data Exchange (caBIG Integration Hub (formerly caXchange)) system is the clinical data exchange component of the Suite, providing a configurable hub for exchanging clinical trial information between applications and systems. caBIG Integration Hub (formerly caXchange) provides the Suite with the ability to exchange clinical trials information in an audited and controlled manner. For instance, caBIG Integration Hub (formerly caXchange) can be used to map and transfer laboratory data from non-standard clinical care systems into a standard format suitable for receipt by clinical trials databases. caBIG Integration Hub (formerly caXchange) uses standard service hub protocols and messaging formats to receive, route, log, and send messages and data between applications.
caAERS
The Cancer Adverse Event Reporting System (caAERS) is an open source, standards-based, web application for documenting, managing, reporting, and analyzing adverse events (AEs). The system operates as both a repository for capturing and tracking routine and serious AEs and as a tool for preparing and submitting expedited AE reports to regulatory agencies. Currently, caAERS works with cancer prevention and therapeutic trials and can accommodate a range of intervention types, including investigational and commercial agents, radiation, surgery, and medical devices. Adverse events can be coded in caAERS using either CTCAE or MedDRA.
To help organizations stay in compliance with AE reporting regulations, the caAERS application comes loaded with a full complement of industry-standard AE reports, including the FDA MedWatch 3500A form, the CTEP AdEERS reports, the NCI-DCP SAE form, and CIOMS. In addition, the caAERS system features a powerful, state-of-the-art rules engine, which can capture a range of sponsor, institution, and protocol-level reporting requirements.
Using these rules, caAERS can automatically determine if an adverse event requires expedited reporting and when and to whom the report must be submitted -- for any of an organization's trials. The business rules used by caAERS can be authored within the application itself or imported from a library of approved rule sets. caAERS also features an advanced email-based alert system that can be customized along a number of dimensions (message content, recipients, delivery times) to ensure that notifications and reminders are sent out as needed. Also included as part of caAERS is an easy-to-use report template generator, which allows users to build and customize reports. caAERS can be deployed as a stand-alone application or as an integrated module within the caBIG® Clinical Trials Suite.
C3PR
The Cancer Central Clinical Participant Registry (C3PR) is a web-based application used for end-to-end registration of patients to clinical trials. This includes capturing the consent signed date, eligibility criteria, stratification, randomization, and screening. Clinical workflows are enabled by both subject- and study-centric views into the registration process. C3PR can be run in a standalone mode where study definitions, investigators, study personnel, and sites are entered into the system, or C3PR can be run in an integrated mode with the caBIG® Clinical Trials Suite. C3PR also enables multi-site clinical trials where registration information is entered locally at affiliate sites and the registration is completed by call-out to the coordinating site.
Patient Study Calendar
The Patient Study Calendar (PSC) is an open source, standards-compliant software application intended for use by organizations that manage patients on clinical trials. PSC is a web-based application providing the ability to create and edit study calendar templates, generate and view prospective calendars of patient activities, track activities as they occur, and manage patient calendars as they change during a study. PSC accommodates all types of studies and facilitates management of the screening process, registration, active monitoring, and long-term follow-up. PSC supports multi-site environments as well as the ability to share templates between instances of PSC.
LabViewer
The Lab Viewer facilitates the automatic capture, translation and import of data from clinical systems into caBIG®- compatible clinical trials databases by allowing the viewing of clinical laboratory data imported from clinical chemistry and other lab systems (e.g., by caBIG Integration Hub (formerly caXchange)). Data can be searched by Medical Record Number (MRN) and data range, and selected for loading into clinical trials databases. The Lab Viewer also automatically flags lab values that may indicate toxicities.
These systems and tools are interoperable, modular, validated, open source, and freely available. In addition, caBIG®'s Applications Support provides technical support for caBIG® tools via several mechanisms (phone, email, web form) and many of these tools have supporting training modules in the Access caBIG® Training section.
In addition to the new tools and technologies being introduced by the CTMS Workspace, efforts are underway to address four informatics-focused recommendations made by the NCI's Clinical Trials Working Group (CTWG), a national body of cancer research experts, in their June 2005 report.
Work being done on these four recommendations include a core library of harmonized and standardized Phase II and III electronic case report forms (eCRFs) to speed data capture and enable the comparison and aggregation of information across the NCI's clinical trials portfolio, a clinical trials database that will contain information on all NCI-supported clinical trials, an investigator and site credential repository, and the implementation of technologies to enable NCI internal and external systems to more easily share information.
Infrastructure
Biomedical Research Integrated Domain Group (BRIDG) Model
The BRIDG Model is a comprehensive domain analysis model representing biomedical/clinical research.
The BRIDG Model is a collaborative effort of stakeholders from the Clinical Data Interchange Standards Consortium (CDISC), the HL7 Regulated Clinical Research Information Management Technical Committee (RCRIM TC), the National Cancer Institute (NCI), and the US Food and Drug Administration (FDA) to produce a shared view of the dynamic and static semantics that collectively define a shared domain-of-interest, i.e. the domain of clinical and pre-clinical protocol-driven research and its associated regulatory artifacts.
The BRIDG model is an instance of a Domain Analysis Model (DAM). As such, it depicts a shared representation of the dynamic and static semantics of a particular domain-of-interest. In the case of the BRIDG model, the domain is defined as:
Protocol-driven research and its associated regulatory artifacts, i.e. the data, organization, resources, rules, and processes involved in the formal assessment of the utility, impact, or other pharmacological, physiological, or psychological effects of a drug, procedure, process, or device on a human, animal, or other biologic subject or substance plus all associated regulatory artifacts required for or derived from this effort.
VI. Policies, Guidelines, & Whitepapers
To see a list of all caBIG® policies and guidelines, visit the Policies, Guidelines & Whitepapers section.
