System for Electronically Recording and Sharing Medical Information

Abstract

A system for electronically recording and sharing medical data is provided, the system comprising an electronic source document, wherein the electronic source document comprises a database. In one particular embodiment, the medical data comprise clinical study data, and in another the medical data comprise patient specific data. In some embodiments, the system includes means for defining data parameters and storing the data parameters within the electronic source document, as well as a browser-based means for entering data into the electronic source document and storing the data therein. In a further embodiment, the system comprises means for one or more users of the system to view stored data. In a still further embodiment, means for one or more users to amend data stored in the electronic source document is provided, and in yet another embodiment the system comprises means for creating and maintaining an audit trail when one or more of the users amends data stored in the electronic source document. In other embodiments, the system further comprises an application specific navigation tool; in some embodiments, the application specific tool comprises a graphical user interface. Appropriate methods of using the system are also provided.

1 . A system for recording and sharing medical record data or data relating to a medical clinical trial and patient data associated therewith in a manner that creates and preserves an electronic record of stored original data so that a verifiable electronic source document is created and preserved, said system comprising:
 a first electronic processing device disposed in communication with a software package that is capable of variably and selectively defining a plurality of access and permissions managers selected from medical care and clinical trials principals in an access and permissions manager selection set comprising a physician, a licensed health care provider, a clinical trial investigator, a medical record administrator, a clinical trial data record administrator, a site management organization, a contract research organization, a clinical trial administrator, a clinical trial monitor, a regulatory agency, a clinical trial sponsor, and an institutional or ethical review board, each of whom is capable of variably and selectively assuming a plurality of roles, including the roles of the other access and permissions managers; defining a plurality of roles associated with said plurality of access and permissions managers; defining a plurality of access and permissions sets for said plurality of roles of the access and permissions managers; and associating the assignments of the plurality of roles to the plurality of access and permissions managers; variably and selectively defining the assignments of the plurality of roles to the access and permissions managers, and the plurality of access and permissions sets for the plurality of roles of the access and permissions managers;   a database, wherein said database further comprises data tables that contain fields defined for receiving and storing medical record data or medical clinical trial data, and patient data associated therewith; and   a second electronic processing device disposed in communication with said first electronic processing device, said software package and said database, said second electronic processing device further comprising a graphical user interface that displays a plurality of defined data fields associated with corresponding data fields defined within the database,   wherein access to said plurality of defined data fields displayed in said graphical user interface, and therefore to corresponding data fields defined within said database, is controlled by said plurality of access and permissions managers variably and selectively providing and restricting access to said plurality of defined data fields in response to the setting of associated access and password restrictions controlled by said plurality of access and permissions managers; and   wherein said system further comprises a means for optional integration with one or more other data storage or management systems, said means for optional integration further comprising means for transmitting data to and receiving data from said one or more other data storage or management systems.   
     
     
         2 . The system of  claim 1 , further comprising means for eliminating duplication of data by capturing and transmitting electronic source data. 
     
     
         3 . The system of  claim 1 , further comprising means for automatically populating electronic study forms using data obtained from said electronic source documents. 
     
     
         4 . The system of  claim 1 , further comprising means for reducing transcription errors and improving the quality of data. 
     
     
         5 . The system of  claim 1 , further comprising means for entering source data at a point of care. 
     
     
         6 . The system of  claim 1 , further comprising means for remote monitoring of data in order to reduce onsite visits by industry regulators. 
     
     
         7 . The system of  claim 1 , further comprising means for site monitoring in order to minimize the need for cross-reference data in multiple sources. 
     
     
         8 . The system of  claim 1 , further comprising means for investigators to conduct clinical research. 
     
     
         9 . The system of  claim 1 , further comprising means for inspection and reconstruction of clinical investigations by regulatory agencies. 
     
     
         10 . The system of  claim 1 , further comprising means for improving standards-based technology in order to encourage widespread adoption of the system. 
     
     
         11 . A method of recording and sharing medical record data or data associated with a medical clinical trial and patient data associated therewith in a manner that creates and preserves an electronic record of stored original data so that a verifiable electronic source document is created and preserved, said method comprising:
 disposing a first electronic processing device in communication with a software package that is capable of variably and selectively defining a plurality of access and permissions managers selected from medical care and clinical trials principals in an access and permissions manager selection set comprising a physician, a licensed health care provider, a clinical trial investigator, a medical record administrator, a clinical trial data record administrator, a site management organization, a contract research organization, a clinical trial administrator, a clinical trial monitor, a regulatory agency, a clinical trial sponsor, and an institutional or ethical review board, each of whom is capable of variably and selectively assuming a plurality of roles, including the roles of the other access and permissions managers; defining a plurality of roles associated with said plurality of access and permissions managers; defining a plurality of access and permissions sets for said plurality of roles of the access and permissions managers; and associating the assignments of the plurality of roles to the plurality of access and permissions managers; variably and selectively defining the assignments of the plurality of roles to the access and permissions managers, and the plurality of access and permissions sets for the plurality of roles of the access and permissions managers;   disposing a second electronic processing device in communication with said software package and said database, said second electronic processing device further comprising a graphical user interface that displays a plurality of defined data fields associated with corresponding fields defined within the database, wherein access to said plurality of defined data fields displayed in said graphical user interface, and therefore to corresponding data fields stored within the database, is controlled by a said plurality of access and permissions managers variably and selectively providing and restricting access to said plurality of data fields defined in said database in response to the setting of associated access and password restrictions controlled by said plurality of data managers; and   disposing said system in communication with a means for optionally integrating said system with one or more other data storage or management systems, said means for optionally integrating further comprising means for transmitting data to and receiving data from said one or more other data storage or management systems.   
     
     
         12 . The method of  claim 11 , further comprising: eliminating duplication of data by capturing and transmitting electronic source data. 
     
     
         13 . The method of  claim 11 , further comprising: automatically populating electronic study forms using data obtained from said electronic source documents. 
     
     
         14 . The method of  claim 11 , further comprising: reducing transcription errors and improving the quality of data. 
     
     
         15 . The method of  claim 11 , further comprising: entering source data at a point of care. 
     
     
         16 . The method of  claim 11 , further comprising: monitoring of data in order to reduce onsite visits by industry regulators. 
     
     
         17 . The method of  claim 11 , further comprising: monitoring sites in order to minimize the need for cross-reference data in multiple sources. 
     
     
         18 . The method of  claim 11 , further comprising: enabling investigators to conduct clinical research. 
     
     
         19 . The method of  claim 11 , further comprising: inspecting and reconstructing clinical investigations by regulatory agencies. 
     
     
         20 . The method of  claim 11 , further comprising: improving standards-based technology in order to encourage widespread adoption of the system.