Abstract:
Users can use a portal for remote monitoring of clinical trials and the sites, personnel, and patients involved. A scheduling function allows users to schedule access. Site sponsors can run productivity reports.

Description:
REFERENCE TO RELATED APPLICATION 
       [0001]    The present application claims the benefit of U.S. Provisional Patent Application No. 61/503,856, filed Jul. 1, 2011, whose disclosure is hereby incorporated by reference in its entirety into the present disclosure. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention is directed to a computer-implemented system and method for remote monitoring of clinical trials and of the sites and personnel participating in those trials. 
       DESCRIPTION OF RELATED ART 
       [0003]    U.S. patent application Ser. No. 12/392,998, filed Feb. 25, 2009, titled SYSTEM AND METHOD FOR ANALYZING, COLLECTING AND TRACKING PATIENT DATA ACROSS A VAST PATIENT POPULATION, whose disclosure is hereby incorporated by reference in its entirety into the present disclosure, discloses a system and method of for analyzing, collecting, and tracking patient data across a vast patient population comprising a plurality of Electronic Health Record (EHR) systems provided at a plurality of healthcare provider sites, each EHR system comprising at least one means for capturing data for a plurality of patients in real time; comprising at least one research system for generating a dataset by performing at least one of analyzing, collecting, and tracking the data captured by the plurality of EHR systems in real time as the data is captured or from a database on which the captured data is stored; and comprising at least one workstation for setting the criteria by which the research system analyzes, collects and tracks the data captured by the plurality of EHR systems and for viewing the dataset generated by the at least one research system, wherein the dataset includes the data that corresponds to each of the criteria set at the workstation. 
         [0004]    However, there is no provision for remote monitoring of clinical trials and the sites, personnel, and patients involved, as well as a scheduling function that allows users to schedule access and the ability of site sponsors to run productivity reports. 
       SUMMARY OF THE INVENTION 
       [0005]    It is therefore an object of the invention to provide such functionality. 
         [0006]    To achieve the above and other objects, the present invention is directed to a computer-implemented method for remotely monitoring studies and the sites performing those studies, the method comprising: (a) receiving, into a computer, a scheduling request from a user to monitor the studies and the sites; (b) automatically remotely monitoring the studies and the sites from the computer in accordance with the scheduling request; and (c) allowing the user to search, using the computer, for information regarding the studies and the sites. The invention is further directed to a corresponding system and to a non-transient medium storing code for carrying out the invention. 
         [0007]    The following is a disclosure of the invention in at least one embodiment. When screen shots of user interfaces are shown, it is considered that those skilled in the art who have reviewed the present disclosure will readily appreciate both the hardware and the coding to be used to implement such user interfaces. The present invention can be implemented on any computer-based medical records system, now or later to be developed, including without limitation stand-alone, LAN-based, and Internet-based medical records systems. The invention is usable with the invention disclosed in the above-cited &#39;998 application. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]    A preferred embodiment will be set forth with reference to the drawings, in which: 
           [0009]      FIG. 1  is a screen shot showing a login screen; 
           [0010]      FIG. 2  is a screen shot showing the login screen in the event of a login failure; 
           [0011]      FIG. 3  is a screen shot showing an email with a temporary user ID and password; 
           [0012]      FIG. 4  is a screen shot showing a change of password; 
           [0013]      FIG. 5  is a screen shot showing a screen for requesting a password reset; 
           [0014]      FIG. 6  is a screen shot showing access scheduling; 
           [0015]      FIG. 7  is a screen shot showing a message that there is no access request scheduled; 
           [0016]      FIG. 8  is a screen shot showing the selection of a trial, site, or patient; 
           [0017]      FIG. 9  is a screen shot showing a patient&#39;s medical record; 
           [0018]      FIG. 10  is a screen shot showing a list of documents in a patient&#39;s medical chart; 
           [0019]      FIG. 11  is a screen shot showing a document from the list of  FIG. 10 ; 
           [0020]      FIG. 12  is a screen shot showing the scheduling of access; 
           [0021]      FIG. 13  is a screen shot showing the process of scheduling access; 
           [0022]      FIG. 14  is a screen shot showing a message for confirmation of an access request; 
           [0023]      FIG. 15  is a screen shot showing a view of all access requests for a week; 
           [0024]      FIG. 16  is a screen shot showing a message to confirm cancellation of an access request; 
           [0025]      FIG. 17  is a screen shot showing the status of an access request; 
           [0026]      FIG. 18  is a screen shot showing a schedule log; 
           [0027]      FIG. 19  is a screen shot showing selection of trials for which a monitor is appointed; 
           [0028]      FIG. 20  is a screen shot showing an audit report; 
           [0029]      FIG. 21  is a screen shot showing the selection of a trial that a CRO oversees; 
           [0030]      FIG. 22  is a screen shot showing an audit report; 
           [0031]      FIG. 23  is a screen shot showing entry of a date range for a financial report; 
           [0032]      FIG. 24  is a screen shot showing a financial report; 
           [0033]      FIG. 25  is a screen shot showing management of users; and 
           [0034]      FIG. 26  is a schematic diagram showing hardware on which the preferred embodiment can be implemented, 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0035]    A preferred embodiment of the present invention will be set forth in detail with reference to the drawings, in which like reference numerals refer to like elements or steps throughout. 
         [0036]      FIG. 1  shows a login screen  100 . To login to the portal and gain access to the homepage for the specific user type, user must enter correct username/password combination into the boxes  102 ,  104  and click on ‘Login’ button  106 . If the entered combination of username/password is not correct, the user will see a message “Login failed” on the login page screen, shown in  FIG. 2  as  200 . Also, users disabled by Admin will not be able to login to Research Portal and will get a system message “Login failed” when trying to login to the portal. 
         [0037]    For first time users, a unique username and a temporary password will be assigned and sent via email, shown in  FIG. 3  as  300 , to the user to gain access to the login portal. The user will be prompted to reset their password through the dialog box  400  of  FIG. 4  and may change it according to the specified requirements. 
         [0038]    To regain a forgotten password, the user must click on ‘Forgot Password?’ link  108  of  FIG. 2 . The system will to generate a dialog box  500  of  FIG. 5 , allowing the user to input the username for which a new password should be created. After the user enters his/her username in the box  502  and clicks on the ‘Reset Password’ button  504 , an email with a temporary password generated by the portal will be sent to the user&#39;s email address, as described above. The new password can be refused if it does not meet a complexity standard set by the system, the two entries of the new password do not match, or the user has not entered the correct old password. 
         [0039]    The monitor view will now be described. 
         [0040]    The monitor sees the screen  600  of  FIG. 6 . If a monitor has an access request scheduled for the day of access to the portal, the user will be able to view and navigate through the ‘Schedule’ tab  602 , ‘Monitor’ tab  604 , and ‘Productivity Report’ tab  606 . If a monitor does not have an access request scheduled for the day of access to the portal, a system message shown in  FIG. 7  as  700  will appear on the screen. After viewing it and clicking the ‘Ok’ button  702 , the user will be navigated to ‘Schedule’ tab and will be able to schedule access for the day. 
         [0041]    To navigate through and select from a list of trials to which the monitor is appointed, the user must click on the ‘Trials’ tab  802  in the screen  800  of  FIG. 8 . To navigate through and select from a list of sites participating in a particular trial, the user must click on the trial from a list  804  on the left side of the screen. To navigate through and select from a list of patients associated with a particular site, the user must click on the site from a list  806  on the left side of the screen. The user is able to utilize a search tool to navigate through trials, sites, and patients in order to locate needed subjects easily. 
         [0042]    To access a patient&#39;s medical record and medical record documents, the user must select the patient from a list  808  on the left side of the screen. The patient&#39;s medical record, shown in  FIG. 9  as  900 , contains demographic and medical information pulled from PrimeSUITE. The medical record title must contain the patient&#39;s name. 
         [0043]    The user can switch between the “Medical Record” tab  209  and the “Medical Record Documents” tab  904 . The ‘Medical Record Documents’ tab  904  contains a list of all saved and signed documents from a patient&#39;s medical chart, shown in  FIG. 10  as  1000 . To view and navigate through a particular document from the list, the user must click on the document  1002  which is then displayed in a new window, shown in  FIG. 11  as  1100 . The user is able to print a selected document should the trial call for printing. The user is able to search for a key word within an open medical document in order to locate that word easily. 
         [0044]    To navigate through and select from a list of trials to which the monitor is appointed, the user must click on ‘Trials’ Tab. To navigate through and select from a list of sites participating in a particular trial, the user must click on the trial from a list on the left side of the screen. The user is able to utilize a search tool to navigate through trials and sites in order to locate needed subjects easily. 
         [0045]    To schedule access for a specific date for a particular site, the user uses the screen  1200  of  FIG. 12 . The user must drag and drop the site button  1202  on the selected calendar cell  1204 , as shown in  FIG. 13 , and click on the ‘Request Access’ button  1206 . The system will generate a message shown in  FIG. 14  as  1400 , asking the user to review access dates and confirm the request. To view upcoming scheduled monitoring sessions, the user must click on the ‘Upcoming Schedule’ menu item  1208  on the left side of the screen. 
         [0046]    To view all access requests for a specific date, the user must click on the ‘Week’ button  1210  or the “Month” button  1212 . The result is shown in  FIG. 15  as  1500 . To cancel an access request to a specific site, the user must click on “x” on the site button from a month view, week view, or upcoming schedule section. A dialog window, shown in  FIG. 16  as  1600 , appears on the screen asking the user to confirm cancelation of the access request. 
         [0047]    To view the status of an access request (Scheduled, Canceled, In Progress, Completed), the user must navigate to the site button on a month or week view, as shown in the screen  1700  of  FIG. 17 , in which a canceled access request  1702  is shown. 
         [0048]    To view a log of all scheduling activities performed by the monitor (schedule or cancel), the user must click on the ‘Schedule Log’ tab  1214 . The schedule log is shown in  FIG. 18  as  1800 . The user is able to print the Schedule Log by clicking on the ‘Print’ button  1802  on the left top corner of the report window. 
         [0049]    To navigate through and select from a list of trials to which the monitor is appointed, the user must click on a ‘Trial’ tab  1902  on the screen  1900  of  FIG. 19 . The user is able to utilize a search tool to navigate through trials in order to locate needed subjects easily. 
         [0050]    To view a Productivity Report, the user must select the “Productivity Report” tab  606 , which brings up the screen  2000  of  FIG. 20 . The user set a desired date range using the date boxes  2002  and  2004 , select all or specific actions form the list  2006 , and click on the ‘Run Report’ button  2008  (for Monitor View a list of monitors contains only one row that reflects his/her name). The Productivity Report  2010  allows the user to view the date and time of a specific action performed within the portal. A list of actions includes: Click Login, Click Logout, Schedule View Select Trial, Schedule View select Site, Schedule View Schedule Dates, Schedule View Cancel Dates, Monitor View Select Trial, Monitor View Select Site, Monitor View Select Patient, Medical Record Tab Selected, Medical Record Documents List Tab Selected, Medical Record Select Document, Medical Record Close Document. The user is able to print the Productivity Report by clicking on the ‘Print’ button  2012  on the left top corner of the report window. 
         [0051]    The sponsor/CRO view will now be disclosed. 
         [0052]    To navigate and select from a list of trials which a CRO oversees, the user must click on the ‘Trials’ Tab. In the screen  2100  of  FIG. 21 , to navigate and select from a list of monitors appointed to monitor a particular trial, the user must click on a selected trial from a list  2102  on the left side of the screen. The user is able to utilize a search tool to navigate through trials in order to locate needed subjects easily. 
         [0053]    The user is able to select a monitor that he/she wants to run an Audit Report for from the list  2104  or click on the ‘All’ box  2106  and select all monitors appointed to the trial at once. To view an Audit Report, the user must set a desired date range in the date boxes  2108 ,  2110 , select all or specific actions form the list  2112 , and click on the ‘Run Report’ button  2114 . The Audit Report allows the user to view the date and time of a specific action performed by selected monitors within the portal. A list of actions includes: Click Login, Click Logout, Schedule View Select Trial, Schedule View select Site, Schedule View Schedule Dates, Schedule View Cancel Dates, Monitor View Select Trial, Monitor View Select Site, Monitor View Select Patient, Medical Record Tab Selected, Medical Record Documents List Tab Selected, Medical Record Select Document, Medical Record Close Document. The user is able to print an Audit Report, shown in  FIG. 22  as  2200 , by clicking on the ‘Print’ button  2202  on the left top corner of the report window. 
         [0054]    To select from a list of existing trials and run a financial report for an individual trial, the user must select the ‘Trials’ tab on the left side of the screen, which brings up the screen  2300  of  FIG. 23 . To select the specific trial, the user must click on the that trial in the list  2302 , which will then allow the user to input data into ‘From’ and ‘To’ date boxes  2304 ,  2306  and click on the “Run Report” button  2308 . The user is able to utilize a search tool to navigate through trials in order to locate needed subjects easily. 
         [0055]    The user then will be able to view dates that an access had been scheduled for, how many monitors monitored on those dates, and the sum based on predetermined amount. In addition, the user will be able to review the total amount owed to the service for utilizing RMS system. The financial report is shown in  FIG. 24  as  2400 . The user is able to print a Financial Report by clicking on the ‘Print’ button  2402  on the left top corner of the report window. 
         [0056]    The ‘User Admin’ tab brings up the screen  2500  of  FIG. 25 , which allows the CRO/Sponsor to add other RMS users (other CROs and/or Monitors) to have access to the RMS portal so that they may view tabs and documents assigned to the user type created. The Admin is also able to select from a list of existing RMS users to view or edit their information. The user is able to utilize a search tool to navigate through the list of users in order to locate needed information easily. 
         [0057]    To clear all fields on the screen, the Admin must click on the ‘New’ button  2502 . Once all the fields are cleared, the Admin may enter required information for a new user. To create a new user, the Admin must enter information to all the required fields and click on the ‘Save’ button  2504 . Once a new user is added, the created username will appear on the list on the left side of the screen, and the Admin will be able to view or edit the user&#39;s information. 
         [0058]    To view a list of existing users, the Admin must select the Organization  2506  from a menu on the left side of the screen by clicking on it. To view or edit an existing user&#39;s information, the Admin must select a user from the list  2508  on the left side of the screen. The selected user&#39;s information will be populated in the fields, allowing the Admin to edit the user&#39;s data. After all needed changes are made; the Admin must click on the ‘Save’ button to push the new data into the database. To enable/disable an existing user, the Admin must check/uncheck the led check box and click on the ‘Save’ button. The system will generate a message notifying the Admin that the user&#39;s information has been updated. 
         [0059]      FIG. 26  shows an illustrative example of hardware on which the preferred or any other embodiment can be implemented. A server  2602  is programmed to implement the functionality of the present invention as well as that of the &#39;998 application. The server communicates over a communication link  2604 , the Internet  2606  or any other suitable communication network, and a communication link  2608  with a client device  2610 . The client device  2610  is any device capable of running a Web browser and can be, e.g., a desktop, laptop, netbook, or tablet computer. The communication links can be wired or wireless (e.g., WiFi or cellular). 
         [0060]    While a preferred embodiment has been set forth in detail, those skilled in the art who have reviewed the present disclosure will readily appreciate that other embodiments can be realized within the scope of the invention. For example, screen layouts are illustrative rather than limiting. Therefore, the scope of the invention should be construed as limited only by the appended claims.