| 摘要 |
A system for providing secure and accurate acquisition of data such as clinical trials data, from a plurality of sites comprises a plurality of mobile user stations and a plurality of validator stations which intercommunicate. The user stations include a mobile computer, communication links, in-terface to local medical devices to provide for capture of medical data and bar code printers for recording physical items and provide for user to fill an electronic case record form (CRF). When complete the form is digitally signed by a signature derived from a biometric authentication of the user and is sub-mitted for immediate validation by the validator. The validator can either validate and sing off the form using a biometrically driven digital signature or can request correction of certain part of the form. Both the final form and any earlier version of it are stored in a secured database. The electronic case record forms are encoded in XML, with any arbitrary binary data encoded in Radix64. For digital signing of the forms the XML documents are normalized by removing contentless white spaces and converting text to Unicode before application of the digital signature algorithm. The digital signature and public key are encoded as Radix64 and appended to the XML document for transmission.
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