Clinical monitoring device with time shifting capability

Abstract

The present invention is designed to develop research protocols for clinical trials. The invention can track and enhance subject compliance with a research protocol. The invention further provides evaluability data related to subject performance in the clinical trial. According to an alternative embodiment of the invention, a portable electronic device is used to query and collect data from the subject.

Having described the invention, what is claimed as new and protected by Letters Patent is: 
     
         1 . A clinical monitoring device comprising:
 a clock, wherein the clock comprises a time and date of the clinical monitoring device as the clinical monitoring device executes a protocol based on a trial that defines a predetermined time and date for scheduled elements and events in the trial to occur, and wherein the time and date of the clock determine an operational state of the clinical monitoring device;   a data recording software including computer executable code for:   (a) collecting a first health data set from a subject or a clinician during a first time range and a second health data set from the subject or the clinician during a second time range, at least one of the second health data set and the second time range being determined in part based on a content of the first health data set, wherein the first and second time ranges are part of the protocol based on the trial;   (b) recording the first and second health data sets in a computer readable medium; and   (c) including a time and date with the recorded health data sets received in the computer readable medium;   a data input feature for receiving the health data sets from the subject or the clinician; and a display having a screen for displaying information corresponding to an operational state of the device.   
     
     
         2 . The device of  claim 1 , further comprising a time software with computer executable code to allow, when activated, an adjustment of the clock from a first event in the protocol, corresponding to a first operational state of the device, relative to a second event in the protocol, corresponding to a second operational state of the device, the device operating at the second event of the protocol in the same manner to collect health data from the subject or clinician in the same manner as if the device had reached the second event without intervention by the time software and resulting in initiation of a second operational state of the device;
 wherein the time software further contains executable code that does not allow adjustment of the date and/or time to alter an operational state of the device to move to the second event in the protocol when the time software is not initiated;   wherein adjustment of the clock from the first event in the protocol to the second event in the protocol changes an operational state without modification to the trial.   
     
     
         3 . The device of  claim 1  or  2 , wherein the computer executable code for collecting the first and second sets of health data includes computer executable code to collect diary entries. 
     
     
         4 . The device of  claim 1  or  2 , wherein the computer executable code for collecting the first set of health data during the first time range and the second set of health data during the second time range includes computer executable code to determine the first and second time ranges that correspond to a time of day or a time period relative to an event. 
     
     
         5 . The device of  claim 2 , wherein the time software with computer executable code to allow an adjustment of the clock includes computer executable code to adjust an operating time and date of the device by selecting an event instead of specifying an actual time. 
     
     
         6 . The device of  claim 2 , wherein the time software with computer executable code to allow an adjustment of the clock includes computer executable code to set the second event in the protocol to a specific event relative to a time range during which the subject or clinician is allowed to enter health data. 
     
     
         7 . The device of  claim 2 , wherein the computer executable code to allow an adjustment of the clock includes computer executable code to set the clock of the clinical monitoring device to a specific event in a schedule of a clinical treatment. 
     
     
         8 . The device of  claim 2 , wherein the computer executable code to allow an adjustment of the clock includes computer executable code to set the second event in the protocol to a point in time selected as a result of a calculation based on health data collected prior to the second event in the protocol. 
     
     
         9 . The device of  claim 1  or  2 , wherein the data recording software includes computer executable code for providing the protocol with a plurality of decision points, and wherein the device executes one or more of the decision points based on health data received from the subject or clinician. 
     
     
         10 . The device of  claim 1  or  2 , wherein the computer executable code for collecting the first and second sets of health data includes computer executable code to collect a diary completed by the subject or clinician. 
     
     
         11 . The device of  claim 1  or  2 , wherein the computer executable code for collecting the first and second sets of health data includes computer executable code to collect a questionnaire completed by the subject or clinician. 
     
     
         12 . The device of  claim 1  or  2 , wherein the computer executable code for collecting the first and second sets of health data includes computer executable code to collect a response of the subject or clinician to a clinical event. 
     
     
         13 . The device of  claim 2 , wherein the computer executable code to allow an adjustment of the clock includes computer executable code for displaying a screen requiring a response from the subject or clinician. 
     
     
         14 . The device of  claim 13 , wherein the computer executable code for displaying the screen requiring a response from the subject or clinician provides a questionnaire for completion by the subject or clinician. 
     
     
         15 . The device of  claim 13 , wherein the computer executable code for displaying the screen requiring a response from the subject or clinician provides a report for completion by the subject or clinician. 
     
     
         16 . The device of  claim 13 , wherein the computer executable code for displaying the screen requiring a response from the subject or clinician includes a request for confirmation of a clinical event. 
     
     
         17 . The device of  claim 13 , wherein the computer executable code for displaying a screen requiring a response provides a request for a subjective response of the subject or clinician to a clinical event. 
     
     
         18 . The device of  claim 2 , wherein the time software further comprises computer executable code for selecting the second event for use in training a user of the clinical monitoring device. 
     
     
         19 . The device of  claim 2 , wherein the time software further comprises computer executable code for selecting the second event for use in testing an application of the clinical monitoring device. 
     
     
         20 . The device of  claim 2 , wherein the computer executable code to allow an adjustment of the clock of the clinical monitoring device includes computer executable code to allow advancing an operating time and date of the clinical monitoring device. 
     
     
         21 . The device of  claim 2 , wherein the computer executable code to allow an adjustment of the clock of the clinical monitoring device includes computer executable code to allow adjusting an operating date and time of the clinical monitoring device to an earlier operating date and time of the clinical monitoring device. 
     
     
         22 .- 40 . (canceled)