DATA MANAGEMENT

Comprehensive Research Information System (CRIS)

CRIS, powered by Velos eResearch®, is a secure web-based Clinical Information Management System in which protocol data and information can be entered efficiently and in a standardize format compliant with NIH reporting standards. The data is entered by site personnel according to established protocols. The comprehensive research information system supports participant recruitment, study monitoring, trial design, protocol management, and data safety monitoring; case report form construction and dissemination; integration of tissue and clinical information; clinical trial execution and query management; and integration with third party clinical systems.

Our Comprehensive Research Information System (CRIS) provides capabilities to:

• create, maintain, and edit participant data, such as demographics, labs, medications, diagnosis, clinical history, and tissue samples;
• create and maintain research protocols;
• track the development of study protocols, versions, amendments, and IRB approvals/renewals;
• create participant screening and enrolling criteria;
• create and disseminate case report forms for clinical trials and outcomes studies;
• create and maintain tissue banks and associate tissue samples with other clinical data at both participant and study levels;
• create participant schedules and record clinical results and participant status in research protocols;
• create user and multi-organization research networks; 9) record, maintain, and report adverse events;
• store and report on all participant- and study-level clinical data;
• conduct study queries and generate standard and ad hoc clinical reports;
• export clinical data to third party analytical tools, such as SAS and Excel.

The comprehensive research information system is also an HL-7 compliant system that is configured to easily integrate with internal as well as third-party lab systems, Electronic Medical Record systems, etc., through one integrally-designed system. The system includes in its software programming to maintain compliance with CFR Part 11 as well as various industry and federal standards. The system can support multi-center, cooperative group and investigator-initiated research through advanced technology and security features, all contained in one comprehensive environment. Through utilization of this comprehensive system great improvements in the research productivity, efficiency, collaboration and integrity of data can be achieved. We have designed the Comprehensive Research Information System using the Velos eResearch product as it allows us to design and develop an extensive and custom application while maintaining a data standard shared by other institutions.