Operation and method for prediction and management of the validity of subject reported data
First Claim
1. A computer implemented method for improving clinical trial data quality, comprising steps of:
- obtaining compliance information from a subject in said clinical trial on a portable electronic device, wherein said compliance information comprises data on timeliness in answering a question or responding to a prompt by said subject;
receiving on a server, over a network from said portable electronic device said compliance information;
applying a decision rule to said compliance information;
determining, based at least on application of said decision rule to said compliance information, that an action should be taken;
identifying a type of action automatically; and
displaying said type of action on an electronic device, wherein said type of action is displayed to a subject, a research site, a sponsor or a clinical trial staff, thereby improving clinical trial data quality.
9 Assignments
0 Petitions
Accused Products
Abstract
A system for developing and implementing empirically derived algorithms to generate decision rules to predict invalidity of subject reported data and fraud with research protocols in surveys allows for the identification of complex patterns of variables that detect or predict subject invalidity of subject reported data and fraud with the research protocol in the survey. The present invention may also be used to monitor invalidity of subject reported data within a research protocol to determine preferred actions to be performed. Optionally, the invention may provide a spectrum of invalidity, from minor invalidity needing only corrective feedback, to significant invalidity requiring subject removal from the survey. The algorithms and decision rules can also be domain-specific, such as detecting invalidity or fraud among subjects in a workplace satisfaction survey, or demographically specific, such as taking into account gender or age. The algorithms and decision rules may be optimized for the specific sample of subjects being studied.
221 Citations
42 Claims
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1. A computer implemented method for improving clinical trial data quality, comprising steps of:
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obtaining compliance information from a subject in said clinical trial on a portable electronic device, wherein said compliance information comprises data on timeliness in answering a question or responding to a prompt by said subject; receiving on a server, over a network from said portable electronic device said compliance information; applying a decision rule to said compliance information; determining, based at least on application of said decision rule to said compliance information, that an action should be taken; identifying a type of action automatically; and displaying said type of action on an electronic device, wherein said type of action is displayed to a subject, a research site, a sponsor or a clinical trial staff, thereby improving clinical trial data quality. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 19, 20, 21, 22, 23, 24)
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11. A non-transitory computer-readable medium suitable for use in an electronic device, said medium comprising instructions that, when executed by said electronic device, cause said electronic device to perform:
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receiving compliance information from a subject in a clinical trial, wherein said compliance information comprises data on timeliness in answering a question or responding to a prompt by said subject; applying a decision rule to said compliance information; determining, based at least on application of said decision rule to said compliance information, that an action should be taken; identifying a type of action automatically; and displaying said type of action on an electronic device, wherein said type of action is displayed to at least one of said subject, a research site, a sponsor or a clinical trial staff, thereby improving clinical trial data quality. - View Dependent Claims (12, 13, 14, 15, 25, 26, 27, 28, 29, 30, 31, 32)
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16. A computer system comprising an electronic device, wherein said electronic device comprises a non-transitory computer-readable medium comprising instructions that, when executed by said computer system, cause said computer system to perform:
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receiving compliance information from a subject in a clinical trial, wherein said compliance information comprises data on timeliness in answering a question or responding to a prompt by said subject; applying a decision rule to said compliance information; determining, based at least on application of said decision rule to said compliance information, that an action should be taken; identifying a type of action automatically; and displaying said type of action on an electronic device, wherein said type of action is displayed to at least one of said subject, a research site, a sponsor or a clinical trial staff thereby improving clinical trial data quality. - View Dependent Claims (17, 18, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
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Specification