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Clinical monitoring device with time shifting capability

a monitoring device and time shifting technology, applied in the field of clinical trials, to achieve the effect of reducing clinical trial costs, increasing statistical power, and enhancing subject complian

Inactive Publication Date: 2014-04-17
ERESTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent describes a system that allows users to adjust the starting and ending dates and times of a clinical monitoring device in a clinical trial. This system can improve data reliability and validity, increase statistical power, reduce trial costs, and ultimately speed up the process of getting a drug or medical device to market.

Problems solved by technology

In some embodiments, 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.

Method used

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Embodiment Construction

[0049]The illustrative embodiment of the present invention is designed to develop research protocols for clinical trials, track and enhance subject compliance with protocol requirements and provide evaluability data related to subject performance in the clinical trial.

[0050]The illustrative embodiment involves an empirically derived set of algorithms and decision rules to predict, track and enhance subject compliance with research protocols. The illustrative embodiment uses algorithms and decision rules to provide an empirical approach for analysis of different types of subject noncompliance with research protocols. This actuarial approach to predicting and managing subject noncompliance with clinical trial protocols is consistent with empirical research demonstrating the superiority of actuarial prediction of human behavior as compared to subjective clinical judgment. According to an alternative embodiment of the invention, a portable electronic device is used to query and collect ...

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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.

Description

REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. Utility application Ser. No. 13 / 603,035, filed Sep. 4, 2012, which is a continuation-in-part of U.S. Utility application Ser. No. 13 / 399,150, filed Feb. 17, 2012, now U.S. Pat. No. 8,433,605, which is a continuation patent application of U.S. Utility application Ser. No. 13 / 211,133, filed Aug. 16, 2011, now U.S. Pat. No. 8,145,519, which is a continuation patent application of U.S. Utility application Ser. No. 09 / 825,533, filed Apr. 2, 2001, now U.S. Pat. No. 8,065,180; the subject matter of this application relates to the patent application titled “Apparatus and Method for Prediction and Management of Subject Compliance in Clinical Research”, U.S. patent application Ser. No. 09 / 825,534, now U.S. Pat. No. 6,879,970, also filed on Apr. 2, 2001; the aforementioned applications, and the references cited therein, are incorporated herein by reference in their entirety.FIELD OF THE INVENTION[0002]The present...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): G06F19/00G16H10/60
CPCG06F19/3406G06F19/36G06Q10/0639G06Q10/10G16H10/20G16H20/00G16H40/63
Inventor HUFFORD, MICHAELPETERSON, DAVIDPATY, JEANSHIFFMAN, SAULMCCLELLAND, JONATHANO'KEEFE, KEVIN DENNIS
Owner ERESTECH
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