Electronic health records in clinical trials

Abstract

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.

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 health 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 health 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;   
     
     
         2 . The method of  claim 1  wherein the receiving the self-reports comprises receiving the self-reports at a fax server in operative communication with the web server. 
     
     
         3 . The method of  claim 2  where the receiving the self-reports comprises receiving the self-reports through an interactive voice response system of a server. 
     
     
         4 . The method of  claim 1  wherein the receiving the self-reports comprises receiving the self-reports through the web site. 
     
     
         5 . The method of  claim 1  wherein the self-reports include bar codes. 
     
     
         6 . The method of  claim 1  wherein the receiving the self-reports comprises receiving the self-reports via text messages from a phone. 
     
     
         7 . A system for electronic health records, comprising:
 a web server programmed to provide a secure web-based interface to the electronic health records through a first web portal;   means to collect self-reports from an individual participating in a clinical trial and self-reporting by sending messages via phone and communicate the self-reports to the first web portal;   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 and communicate the health care records to the first web portal;   means to receive health monitoring equipment data from health monitoring equipment for acquiring data indicative of a health issue of the individual and create electronic health records from the health monitoring equipment data from the health monitoring equipment;   wherein the first web portal being configured to provide access to the self-reports, the health monitoring equipment data from the health monitoring equipment, and the health care records to the individual.   
     
     
         8 . The system of  claim 7  wherein the web server being programmed to provide emergency access to data of the individual through use of an emergency log-on to the first web portal; wherein the data of the individual includes clinical trial contact information;
 wherein the data includes self-reports associated with the clinical trial; wherein the data includes data selected by the individual for the emergency access; and wherein emergency log-on instructions being provided on an emergency card. 
 
     
     
         9 . The system of  claim 8  wherein the first web portal allows the individual having access through the first web portal to specify health care records to share with the clinical trial sponsor. 
     
     
         10 . A method for assisting in conducting a clinical trial, the method comprising:
 providing participants in the clinical trial with access to a first web portal associated with a web server;   receiving self-reports from the participants in the clinical trial via messaging from phones and storing the self-reports in a computer readable storage medium and making available the self-reports to the participants through the first web portal associated with the web server;   receiving additional medical records associated with the participants from the participants in the clinical trial or health care providers of the participants in the clinical trial and making available the medical records to the participants through the first web portal;   receiving health monitoring equipment data associated with the participants from health monitoring equipment for acquiring data indicative of a health issue of the participants;   sending a reminder to the participants to remind the participants of the need to comply with self-reporting requirements, wherein the reminder comprises a text message, a voice message, an email, a phone call, and/or any combination of the foregoing;   providing a clinical trial sponsor with access to a second web portal, the self-reports from the participants in the clinical trial being made available through the second web portal;   selectively providing the additional medical records to the clinical trial sponsor according to preferences of the participants; and   selectively providing the health monitoring equipment data to the clinical trial sponsor according to preferences of the participants.   
     
     
         11 . A method for collecting self-reported data from an individual, 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; 
   receiving a self-report from the individual from a phone;   creating an electronic health record using the self-report from the individual;   storing the electronic health record on the web site;   receiving data from medical monitoring equipment indicative of a health issue of the individual;   creating an electronic health record using the received data from medical monitoring equipment;   storing the electronic health record on the web site;   receiving an additional health record from a health care provider for the individual at the web site;   storing the additional health record from the health care provider on the web site;   sharing selected health records on the web site as specified by the individual through the web site.   
     
     
         12 . The method of  claim 11  wherein the sharing the selected health records on the web site as specified by the individual through the web site further comprises sharing the selected health records on the web site as specified by the individual through the web site with a clinical trial sponsor. 
     
     
         13 . The method of  claim 12  wherein the clinical trial sponsor accesses the selected health records through a clinical trial sponsor portal.