Zdrowie i gospodarka · 19/08/2008

Electronic Study Data Submission for Phase 3 Janus Operational Pilot; Notice of Pilot Project

The Center for Drug Evaluation and Research (CDER) is seeking sponsors interested in participating in a pilot project to test the submission and processing of clinical study data provided electronically in a standardized format. This pilot will test the data extract, validation, and load procedures developed to populate "Janus," the study data repository component of a common, standards- based infrastructure that is being developed jointly by the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) to support the exchange of clinical research data. The pilot also will test a new XML (extensible markup language)-based submission format for standardized clinical study data. We anticipate that a successful pilot will enable CDER to routinely receive, process, and store all standardized clinical study data in a data warehouse environment that will enhance the center's capability to manage and review standardized study data.