Projects

Current CRIX Projects

CRIX uses a modular, iterative approach to project development. NCICB assembles, maintains and extends pilot components for NCI and FDA initiatives through an open, transparent, and inclusive governance process. The CRIX Steering Committee and other groups provide input to NCICB concerning user requirements. Current projects include:

• The Federal Investigator Registry of Biomedical Information Research Data (FIREBIRD) is the pilot CRIX development project. Firebird automates the Food and Drug Administration (FDA) Form 1572 submission process. Form 1572 is the FDA-required document in which clinical investigators agree to conduct Investigational New Drug (IND) clinical trials according to Federal Regulations.

• JANUS is a standards-based clinical data repository that utilizes the open source data model, Janus. Janus was created by FDA in partnership with IBM under a CRADA. When implemented, Janus will enhance the clinical trial process by allowing the viewing of the data through reviewer-centric tools; cross-study analyses; cross-application analyses; audit capabilities; and enhanced communication of conclusions. It will contain patient information as well as intellectual property information of the sponsor agencies that have supplied the investigational agents.

A series of face-to-face meetings with the steering committee are conducted bi-monthly and conference calls are scheduled regularly to ensure communication and project advancement.