Clinical Trials Management Systems (CTMS) Newcomer Information

Mission and Goals

The Clinical Trials Management Systems (CTMS) workspace is developing a comprehensive set of modular, inter-operable and standards-based tools designed to meet the diverse clinical trials management needs. The tools developed will be configurable to meet the needs of Cancer Centers with little or no clinical data management systems in place as well as those with robust systems, and will take into account the diversity of clinical research activities and local practices that exist among Cancer Centers. Examples of these tools include an adverse event reporting module, a clinical trials participant registry, a patient study calendar, and a lab information exchange module.

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. For more information on the CTWG's four informatics-focused recommendations, click here. 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.

Additional overview materials:

• Overview of the Clinical Trials Management Systems Workspace (June 2007).
• Enabling the Patient-Centric Molecular Medicine Revolution (May 2007).
• CTMS Glossary of Terms
• Looking for information on how caBIG™ helps facilitate clinical data management and data sharing? Check out the Clinical Trials Compatibility Framework
• You can see who is involved in the CTMS Workpace on the list of CTMS Participating Organizations.

How the CTMS Workspace Operates

The CTMS Workspace welcomes participation in the workspace and SIG activities from individuals 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 by emailing the CTMS Workspace coordinator or project manager to get the toll free dial-in number and access code. The CTMS Contact Information section provides contact information for the CTMS Workspace Lead and NCI Coordinators.

Teleconferences: Workspace participants meet regularly via teleconference to discuss issues and devise solutions. The CTMS Workspace meetings are held monthly and listed on the Schedule. To see what the CTMS Workspace has been working on recently, you can review the Meeting Notes from past teleconferences.

Listserv: Between teleconferences the NIH CTMS Listserv is the primary means of collaboration for participants. Discussions, teleconference agendas and dial-in information as well as cancellations are sent out on the listserv 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 listserv.

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, discuss accomplishments, upcoming tasks and future goals. These are announced in What's BIG This Week and distributed through the caBIG™Announce Listserv. To see what has been discussed in previous CTMS face-to-face meetings, click here.

Special Interest Groups (SIGs): The CTMS Workspace has several SIGs that address specific needs. The CTMS SIGs are listed below. To learn more about the SIGs, click on the links in the list below. Each of the four SIGs have an associated task force which will focus on the implementation of one of the four CTWG informatics initiatives and will define high-level functional capability requirements for the tools and applications necessary to implement the relevant initiative. Each task force will also work closely with the teams charged with developing these tools and applications and will serve as the interface between the development teams and the SIG. Additionally, each task force will report periodically to the CTMS Steering Committee on the progress of its respective CTWG Informatics Initiative project. Lastly, each task force will have responsibility for providing direction and input to all other activities and projects being undertaken within its SIG.

What have they done (products)

Tools

The list below provides examples of the informatics systems and tools produced by the CTMS Workspace that are ready for use by the cancer research community. 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.

• Cancer Central Clinical Database (C3D)
  C3D is a clinical trials data management system. C3D collects clinical trial data using standard case report forms (CRFs) based on common data elements (CDEs).
• Cancer Central Clinical Participant Registry (C3PR)
  C3PR is a web-based application for managing clinical trial data across multiple cancer clinical trials. The tool is used to improve clinical trials activation and execution.
• Clinical Data System (CDS)
  The CDS is an independent and stand-alone data submission infrastructure (electronic) which serves as the primary data submission system for NCI-sponsored clinical trials.
• caXchange (formerly Lab Integration Hub)
  caXchange is an open source software tool used to collect, process and report laboratory data gathered during a clinical trial.
• Patient Study Calendar
  This is an open source, standards-compliant software application to manage and schedule patients on cancer clinical trials.
  

To see a more complete listing of all caBIG™ tools, visit the Tools page.

Infrastructure

• Biomedical Research Integrated Domain Group (BRIDG) Model
  The BRIDG Model is a comprehensive domain analysis model representing biomedical/clinical research.

Policies, Guidelines, & Whitepapers

• Clinical Trial Monitoring Service and the Clinical Data Update System (CDUS) Routine Data Exchange Reporting Recommendations. A white paper that highlights the needs for reporting standards that are embodied in caBIG™, including common data definitions, federated reporting requirements, and grid enabled data exchange through caBIG™-compatible mechanisms as enablers of clinical research. The objective of this whitepaper is to delineate the requirements for interoperable reporting and present a set of practices that each institution can adopt. (4/8/2005)

To see a list of all caBIG™ policies and guidelines, visit the Policies, Guidelines & Whitepapers section.