Electronic health records in clinical trials

摘要

A method for collecting self-reported data from an individual for use in a clinical trial is provided. The method includes providing a web site allowing the individual to store, organize, and access personal health records associated with the individual and sharing selected personal health records associated with the individual with a clinical trial sponsor. A system for electronic health records includes a web server programmed to provide a secure web-based interface to the electronic health records, means to collect self-reports from an individual participating in a clinical trial, means to disseminate the self-reports from the individual to a clinical trial sponsor, and means to collect health care records from a health care provider of the individual.

主权项

1. A method for collecting self-reported data from an individual for use in a clinical trial, the method comprising:
providing a web site stored on a web server, the web site enabling the individual to store, organize, and access health records associated with the individual on the web site, the web site further configured to collect the health records by:
(a) receiving self-reports from the individual and creating electronic health records from the self-reports,(b) receiving data from medical monitoring equipment for acquiring data indicative of a health issue of the individual and creating electronic health records from the data, and(c) receiving health records from a health care provider of the individual; collecting the health records at the web site, the collecting the health records comprising
(a) receiving the self-reports from the individual and creating the electronic health records from the self-reports,(b) receiving the data from the medical monitoring equipment indicative of a health issue of the individual and creating the electronic health records from the data, and(c) receiving the health records from the health care provider of the individual; storing the health records on a computer readable storage medium associated with the web site; and sharing selected health records associated with the individual with a clinical trial sponsor through a clinical trial portal, wherein the selected health records are specified by the individual through the web site; providing a wallet card comprising emergency information associated with the individual including an emergency password and a web site identifier associated with the web site; making available through the web site at least a subset of the health records in event of emergency through the emergency information; and making available through the web site clinical trial participation information in event of the emergency through the emergency information.