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Description
| In the March 13, 2007, Federal Register, FDA announced that its Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are seeking sponsors interested in participating in a pilot project to test the submission of case report form (CRF) data provided electronically in extensible markup language (XML) based on the Operational Data Model (ODM) developed by the Clinical Data Interchange Standards Consortium (CDISC). This pilot will test the ability of a new data format to support all FDA review activity, which FDA's current submission format is incapable of doing. Data supplied in ODM format by sponsors during the pilot project will not replace any regulatory requirements for submitting CRFs. FDA anticipates that a successful pilot will allow CDER and CBER to routinely accept CRF from studies... |
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