| 摘要 |
According to the present invention, there is provided a system and method for the collection, capture, processing, storage, and tracking of data for both electronic clinical trial and electronic source health records for purposes, based upon a single data collection instance. Upon the collection of data at a clinical trial site, the data are transmitted to a central server where it is captured as an electronic source document(s) in human readable format. The system then transmits the captured electronic source document to a trusted third-party's electronic document repository. Then, the system uses the same captured data to populate the clinical trial's electronic data capture database. The system incorporates security and encryption features to ensure that privacy information requirements are not violated. In the preferred embodiment, the electronic data capture provider for a clinical trial has no control over the server of the trusted third-party vendor, complying with regulatory requirements. Additionally, the collected data can be pushed into a clinical site's electronic health record system or any equivalent system which houses electronic data. Throughout the operation of the system, an audit trail is maintained which records information relating to all data recording, modifying, and accessing events.
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