System for clinical trial subject compliance
DC CAFCFirst Claim
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1. A method for classifying clinical trial results from one or more participants in a clinical trial, the method comprising:
- a. entering evaluability data from the one or more participants on an electronic device, wherein the evaluability data comprise one or more evaluability data categories; and
b. comparing the evaluability data from the one or more evaluability data categories to a norm to classify the clinical trial results from the one or more participants in the clinical trial based on a type of compliance, wherein the classifying allows analysis of participants with a similar type of compliance.
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Abstract
The present invention is designed to develop research protocols for clinical trials. The invention also 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.
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63 Claims
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1. A method for classifying clinical trial results from one or more participants in a clinical trial, the method comprising:
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a. entering evaluability data from the one or more participants on an electronic device, wherein the evaluability data comprise one or more evaluability data categories; and b. comparing the evaluability data from the one or more evaluability data categories to a norm to classify the clinical trial results from the one or more participants in the clinical trial based on a type of compliance, wherein the classifying allows analysis of participants with a similar type of compliance. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A computer readable medium having stored thereon sequences of instructions, which, when executed by a computer system, cause the computer system to perform:
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a. entering evaluability data from one or more participants on an electronic device, wherein the evaluability data comprise one or more evaluability data categories; and b. comparing the evaluability data from the one or more evaluability data categories to a norm to classify the clinical trial results from the one or more participants in the clinical trial based on a type of compliance, wherein the classifying allows analysis of participants with a similar type of compliance. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
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- 43. A system comprising an electronic device for entering evaluability data from one or more participants, wherein the evaluability data comprise one or more evaluability data categories, wherein the electronic device can compare the evaluability data from the one or more participants to a norm to classify the clinical trial results from the one or more participants in the clinical trial based on a type of compliance, wherein the classifying allows analysis of participants with a similar type of compliance.
Specification