FDA Solicits Electronic Case Report Forms for Pilot Project

The FDA is inviting clinical trial sponsors to participate in a pilot project to test the electronic submission of case report form data in extensible markup language based on the operational data model developed by the Clinical Data Interchange Standards Consortium.

The pilot project is being run by both CDER and CBER. Only five sponsors will be needed. The idea is to test whether the new data format can support all review activities, which the agency's current PDF-based submission format cannot do. Notably, PDF files scanned from paper case report forms or generated by electronic data capture software do not generally provide an audit trail.

The goal of the project is for CDER and CBER to be able to routinely accept electronic case report forms for marketing applications in operational data model format.

Applications to participate in the project must be submitted by the beginning of September. The agency is also accepting general comments on the subject.

The full document announcing the pilot project can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/07n-0064-n000001.pdf ( http://www.fda.gov/OHRMS/DOCKETS/98fr/07n-0064-n000001.pdf ).