Welcome to BTRIS

The Biomedical Translational Research Information System (BTRIS) is a resource available to the NIH intramural community that brings together clinical research data from the Clinical Center and other NIH Institutes and Centers. BTRIS provides clinical investigators with access to identifiable data for subjects on their own active protocols, while providing all NIH investigators with access to data without personal identifiers across all protocols. Data are available from 1976 to the present.

BTRIS Functions

BTRIS Functions - Active Protocols: Reports by protocol; Labs, medications, documentation, images; Download files for analysis. Hypothesis Generation: Query data without personal identifiers; 1976 to present.  Subject Attribution: Check protocol attribution; Add subject based on signed consents; Set preferences for notifications. Clinical Trials Reporting: FDAAA compliance made easy.

Active Protocol Data is available to NIH intramural research team members associated with a protocol. View Introduction to BTRIS PDF Icon (1.76 MB) for additional details.

Hypothesis Generation allows NIH intramural researchers to access clinical research data without personal identifiers from the NIH Clinical Center systems from 1976 to the present. View an overview of BTRIS Data Without Personal Identifiers YouTube Icon [disclaimer].

Subject Attribution is managed through a custom application called Preferences. Users can confirm the association of a subject with an active protocol, or set thresholds for notifications and permissions related to secondary data use.

ClinicalTrials.gov allows NIH intramural researchers to assemble and format data required for FDAAA compliance. Once filing materials are complete in BTRIS, the user may automatically upload the file to ClinicalTrials.gov.

For questions or comment about BTRIS contact Dr. Jim Cimino, Chief, Laboratory for Informatics Development, NIH Clinical Center, National Institutes of Health, Bethesda, MD.


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Page last updated: November 27, 2013