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FDA Launches Pilot Program to test electronic submission of CRFs
Posted on 2007-03-13 16:30:00
SUMMARY: The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA) 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 review activity, which our 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. We anticipate a successful pilot will allow CDER/CBER to routinely accept CRFs from studies employing electronic data capture (EDC) in ODM format in marketing applications provided in electronic format.
DATES: Submit written or electronic requests to participate in the pilot project by September 10, 2007. General comments on the pilot project are welcome at any time.
ADDRESSES: Submit written requests participate and comments regarding pilot project to the Division of Dockets Management (HFA–305), Food and Administration, 5630 Fishers Lane, 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Armando Oliva, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6310, Silver Spring, MD 20993–0002, 301–796–0514.
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