SYSTEM FOR CLINICAL TRIAL SUBJECT COMPLIANCE
First Claim
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1. A method of protocol development for a clinical trial, comprising the steps of:
- a) selecting a clinical trial target reflecting a goal of the clinical trial;
b) determining desired evaluability data categories to be gathered pertaining to one or more participants in the clinical trial;
c) entering evaluability data about the one or more participants, of at least one of the evaluability data categories, on an electronic device; and
d) determining whether to retain the one or more participants in the clinical trial or to incorporate the one or more participants in at least one result of the clinical trial based on the evaluability data about the one or more participants entered on the electronic device.
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Accused Products
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.
12 Citations
69 Claims
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1. A method of protocol development for a clinical trial, comprising the steps of:
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a) selecting a clinical trial target reflecting a goal of the clinical trial; b) determining desired evaluability data categories to be gathered pertaining to one or more participants in the clinical trial; c) entering evaluability data about the one or more participants, of at least one of the evaluability data categories, on an electronic device; and d) determining whether to retain the one or more participants in the clinical trial or to incorporate the one or more participants in at least one result of the clinical trial based on the evaluability data about the one or more participants entered on the electronic device. - View Dependent Claims (3, 54, 55, 56, 57, 58, 68)
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2. (canceled)
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4-36. -36. (canceled)
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37. A compliance monitoring device for use in clinical trials, comprising:
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a portable electronic device capable of displaying information and receiving and storing input from a user, wherein the user is provided feedback based on the determination of whether the user has followed a predetermined protocol for providing the input to the portable electronic device. - View Dependent Claims (38)
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39-53. -53. (canceled)
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59. A method of protocol development for a clinical trial comprising
designing a compliance feature, wherein the designing comprises incorporating standard features, trial specific features, and evaluability needs; - and
incorporating the compliance feature into the protocol. - View Dependent Claims (60, 61, 62, 63, 64, 65, 66, 67, 69)
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Specification