T H E   N I H   C A T A L Y S T     N O V E M B E R  –  D E C E M B E R   2002

G U E S T E D I T O R I A L F R O M T H E C L I N I C A L C E N T E R D I R E C T O R

FROM MIS TO CRIS: STATE OF THE ART INFORMATION SYSTEM
T
O SERVE AS THE 'NERVE CENTER' OF THE NEW CLINICAL RESEARCH CENTER

John Gallin

The roots of information technology at the Clinical Center run deep. We’ve operated an electronic medical information system—the MIS—for a quarter century. Designed to support day-to-day patient care, the MIS sends orders where they need to go, can be used to check results, and allows clinicians to perform some care documentation. As the needs of the intramural clinical research community have grown, the MIS has adapted, through continual customization, as best it could.

It’s appropriate that as the new Clinical Research Center’s walls go up we are simultaneously building the next generation of information systems to support the work that will be carried out there. I consider the Clinical Research Information System—CRIS—–a project as important as the new hospital. It will serve as the CRC’s nerve center, providing a strong, flexible information backbone for the conduct of clinical research.

A continuous record of patient care, adverse event detection, and enhanced communications with referring physicians are a few of the hallmarks of the new clinical information system. CRIS will incorporate capabilities to enhance patient care, including delivery of clinical alerts in real time and online access to reference and resource materials.

At least 24 distinct information systems ultimately will plug into two broad CRIS hubs, the Clinical Data Repository and the Clinical Data Warehouse, both supporting aspects of clinical care, clinical research, and operations management.

The Repository will serve as the electronic medical record, housing information related to patient care and hospital operations—lab results, pharmacy orders, information from referring physicians, and multidisciplinary care documentation, for example. Clinical systems such as radiology, nutrition, pharmacy, and protocol services will feed the Repository.

The Warehouse will be the central resource for historical patient data. Its ancillary systems will provide information needed to support safety and organizational efficiency programs. The Warehouse will be available for data retrieval and analysis while protecting patient privacy and confidentiality. It will offer us remarkable new opportunities for capturing, exploring, analyzing, and using information generated by clinical research.

Innovations in information technology are being introduced at an astonishing rate. Our challenge is to be prepared to use the data at our disposal in ways that speed the contributions of clinical research while safeguarding even more closely the well-being of our patient volunteers.

New capabilities offered by CRIS will mean more users. Projections are that nearly 6,500 CC and clinical research staff will use CRIS, 50 percent more than currently use MIS. Training in how to use the new systems will be an ongoing priority, as will smart project management. Systems integration—making sure that all these new and enhanced systems work together as envisioned—is critical. That team is already in place to ensure project integrity across all stages of development, testing, implementation, and management.

A vendor will soon be selected to provide the core patient-care system. Dedicated teams from throughout NIH invested months of work to detail requirements for the core’s capabilities. Resulting proposals have been closely evaluated. The final decision is critical because the core literally is the foundation for all that we expect from this project.

We have high expectations for CRIS and correspondingly high expectations of those who will use it. We are planning a series of well-publicized, hands-on demonstrations. Members of the clinical research community can try out what's being proposed during these test-drives. We want and need your opinions about how the system will handle everything from ordering medications and accommodating charting to clinical alert displays and protocol pathways.

Better treatments and therapies for patients are the clinical researcher’s ultimate goals. The highest level of training in the conduct of clinical research is an important foundation for achieving this goal. Just as critical is the availability of a dependable framework of support.

In 2000, the Medical Executive Committee detailed overarching principles and processes for NIH’s intramural clinical research community. Topping the list of focus areas are standards in clinical informatics, data management, and protocol tracking. The Clinical Research Information System will be a key element in meeting these standards.

John Gallin
Clinical Center Director

For more about CRIS, visit the website.

CRIS Steering Committee

Cliff Lane, NIAID clinical director (chair)
John Gallin, Clinical Center director, NIH associate director for clinical research, and CRIS program official
Stephen Rosenfeld, Cris project officer and chief, CC Department of Clinical Research Informatics
Elaine Ayrs, CC, executive secretary
Maureen Gormley, CC chief operations officer
Syd Jones, CC, director of procurement and contracts
James Balow, chair, Medical Executive Committee, and NIDDK clinical director
Colleen Barros, project manager, Business and Research Support System project, and NIA executive officer
Don Christoferson, NHLBI executive officer
Marvin Gershengorn, NIDDK scientific director
Michael Gottesman, NIH deputy director for intramural research
Alan Graeff, NIH CIO
Tony Itteilag, NIH Director’s Office
Charles E. Leasure, NIH deputy director for mnagement
Henry McFarland, NINDS clinical director and Clinical Neurosciences Program director
Robert Nussenblatt, chief, NEI Laboratory of Immunology; chief, CC Protocol Services; and chair, Medical Executive Committee Information Technology Subcommittee
Jo Anne Zujewski, head, NCI Breast Cancer Clinical Research Branch

 


Return to Table of Contents