Operation and method for prediction and management of the validity of subject reported data
First Claim
1. A computer implemented method for predicting invalidity of subject reported data collected during a current clinical trial or current survey, the method comprising:
- analyzing one or more historical validity markers associated with at least one earlier clinical trial or earlier survey, the one or more historical validity markers comprising;
timeliness of a subject response;
proximity of data to an expected data range;
a number of missed data entry occasions;
ora number of times an entry was changed;
generating a predictive algorithm for predicting invalidity of subject reported data based at least on the analyzing of the one or more historical validity markers;
translating the predictive algorithm into a decision rule for use with the current clinical trial or current survey, the decision rule specifying an action;
applying the decision rule to one or more validity makers associated with the current clinical trial or current survey; and
determining that the action should be taken based at least on the application of the decision rule to the one or more validity markers associated with the current clinical trial or current survey.
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.
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Citations
93 Claims
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1. A computer implemented method for predicting invalidity of subject reported data collected during a current clinical trial or current survey, the method comprising:
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analyzing one or more historical validity markers associated with at least one earlier clinical trial or earlier survey, the one or more historical validity markers comprising; timeliness of a subject response; proximity of data to an expected data range; a number of missed data entry occasions;
ora number of times an entry was changed; generating a predictive algorithm for predicting invalidity of subject reported data based at least on the analyzing of the one or more historical validity markers; translating the predictive algorithm into a decision rule for use with the current clinical trial or current survey, the decision rule specifying an action; applying the decision rule to one or more validity makers associated with the current clinical trial or current survey; and determining that the action should be taken based at least on the application of the decision rule to the one or more validity markers associated with the current clinical trial or current survey. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 81, 82)
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11. A computer implemented method for determining validity of subject reported data collected during a current clinical trial or current survey and determining if action should be taken, the method comprising:
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analyzing historical validity markers and historical protocol data, the historical validity markers comprising; timeliness of a subject response; proximity of data to an expected data range; a number of missed data entry occasions;
ora number of times an entry was changed; generating, based at least on the analyzing of the historical validity markers and the historical protocol data, an algorithm reflective of the historical validity markers and the historical protocol data; translating the algorithm into a decision rule for analyzing the validity of subject reported data, the decision rule specifying an action; obtaining validity markers for at least one event associated with the current clinical trial or the current survey; applying the decision rule to the validity markers associated with the current clinical trial or current survey; and determining that the action should be taken based at least on the application of the decision rule to the validity markers associated with the current clinical trial or current survey. - View Dependent Claims (12, 13, 14, 15)
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16. A computer implemented method for determining validity of subject reported data collected during a current clinical trial or current survey, the method comprising:
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analyzing historical validity markers and historical protocol data, the historical validity markers comprising; timeliness of a subject response; proximity of data to an expected data range; a number of missed data entry occasions;
ora number of times an entry was changed; generating, based at least on the analyzing of the historical validity markers and the historical protocol data, a spectrum of invalidity representative of the historical validity markers not compliant with the historical protocol data, the spectrum of invalidity specifying a plurality of actions; obtaining one or more validity markers from at least one event associated with the current clinical trial or the current survey; and comparing the spectrum of invalidity to the validity markers; and determining that one of the plurality of actions should be taken based at least on the comparison of the spectrum of invalidity to the validity markers. - View Dependent Claims (17, 18, 28, 83)
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19. A computer implemented method for detecting subject fraud, the method comprising:
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analyzing historical validity markers and historical protocol data associated with at least one earlier clinical trial or earlier survey, the historical validity markers comprising; timeliness of a subject response; proximity of data to an expected data range; a number of missed data entry occasions;
ora number of times an entry was changed; generating, based at least on the analyzing of the historical validity markers and the historical protocol data, a fraud detection algorithm for detecting subject fraud; translating the fraud detection algorithm into a fraud detection rule for use with a current clinical trial or a current survey, the fraud detection rule specifying an action; applying the fraud detection rule to one or more validity markers associated with the current clinical trial or the current survey; and determining that the action should be taken based at least on the application of the fraud detection rule to the one or more validity markers associated with the current clinical trial or the current survey. - View Dependent Claims (84)
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20. A computer implemented method of detecting subject fraud, the method comprising:
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analyzing information indicating validity of subject reported data associated with at least one earlier clinical trial or earlier survey, the information comprising; timeliness of a subject response; proximity of data to an expected data range; a number of missed data entry occasions;
ora number of times an entry was changed; generating, based at least on the analyzing of the information, a fraud detection algorithm for detecting subject fraud during a current clinical trial or current survey; translating the fraud detection algorithm into a fraud detection rule for use with the current clinical trial or the current survey, the fraud detection rule specifying an action; applying the fraud detection rule to one or more validity markers associated with subject reported data from the current clinical trial or current survey; and determining that the action should be taken based at least on the application of the fraud detection rule to the one or more validity markers. - View Dependent Claims (21, 22, 23, 24, 25, 26)
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27. A non-transitory computer-readable medium suitable for use in an electronic device, the medium comprising instructions that, when executed by the electronic device, cause the electronic device to perform:
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analyzing one or more historical validity markers associated with at least one earlier clinical trial or earlier survey, the one or more historical validity markers comprising; timeliness of a subject response; proximity of data to an expected data range; a number of missed data entry occasions;
ora number of times an entry was changed; generating, based at least on the analyzing of the one or more historical validity markers, a predictive algorithm for predicting invalid subject reported data; translating the predictive algorithm into a decision rule for use with a current clinical trial or current survey, the decision rule specifying an action; applying the decision rule to one or more validity markers associated with the current clinical trial or the current survey; and determining that the action should be taken based at least on the application of the decision rule to the one or more validity markers associated with the current clinical trial or the current survey. - View Dependent Claims (29, 30, 31, 32, 33, 34, 85)
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35. A non-transitory computer-readable medium suitable for use in an electronic device, the medium comprising instructions that, when executed by the electronic device, cause the electronic device to perform:
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analyzing one or more historical validity markers and historical protocol data associated with one or more earlier clinical trials or earlier surveys, the one or more historical validity markers comprising; timeliness of a subject response; proximity of data to an expected data range; a number of missed data entry occasions;
ora number of times an entry was changed; generating an algorithm for predicting validity of subject reported data based at least on the analyzing of the one or more historical validity markers and the historical protocol data; translating the algorithm into a decision rule for analyzing information on validity of subject response data, the decision rule specifying an action; obtaining validity markers for at least one event associated with a current clinical trial or current survey; applying the decision rule to the validity markers associated with the current clinical trial or the current survey; and determining that the action should be taken based at least on the application of the decision rule to the validity markers associated with the current clinical trial or the current survey. - View Dependent Claims (36, 37, 38, 86)
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39. A non-transitory computer-readable medium suitable for use in an electronic device, the medium comprising instructions that, when executed by the electronic device, cause the electronic device to perform:
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analyzing historical validity markers and historical protocol data associated with one or more earlier clinical trials or earlier surveys, the one or more historical validity markers comprising; timeliness of a subject response; proximity of data to an expected data range; a number of missed data entry occasions;
ora number of times an entry was changed; generating a spectrum of invalidity representative of the historical validity markers not compliant with the historical protocol data based at least on the analyzing of the historical validity markers and the historical protocol data, the spectrum of invalidity specifying a plurality of actions; obtaining validity markers for at least one event associated with a current clinical trial or current survey; comparing the spectrum of invalidity to the validity markers; and determining that one of the plurality of actions should be taken based at least on the comparison of the spectrum of invalidity to the validity markers. - View Dependent Claims (40, 41, 87)
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42. A non-transitory computer-readable medium suitable for use in an electronic device, the medium comprising instructions that, when executed by the electronic device, cause the electronic device to perform:
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analyzing historical validity markers and historical protocol data associated with one or more earlier clinical trials or earlier surveys, the historical validity markers comprising; timeliness of a subject response; proximity of data to an expected data range; a number of missed data entry occasions;
ora number of times an entry was changed; generating a fraud detection algorithm for detecting subject fraud based at least on the analyzing of the historical validity markers and the historical protocol data; translating the fraud detection algorithm into a fraud detection rule, the fraud detection rule specifying an action; and determining that the action should be taken based at least on an application of the fraud detection rule to validity markers associated with a current clinical trial. - View Dependent Claims (43, 44, 45, 46, 47, 48, 49, 88)
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50. A non-transitory computer-readable medium suitable for use in an electronic device, the medium comprising instructions that, when executed by the electronic device, cause the electronic device to perform:
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analyzing information on the validity of subject reported data associated with one or more earlier clinical trials or earlier surveys, the information comprising; timeliness of a subject response; proximity of data to an expected data range; a number of missed data entry occasions;
ora number of times an entry was changed; generating a fraud detection algorithm for detecting subject fraud based at least on the analyzing of the information; and translating the fraud detection algorithm into a fraud detection rule for use during a current clinical trial, the fraud detection rule specifying an action; and determining that the action should be taken based at least on an application of the fraud detection rule to validity markers associated with a current clinical trial or current survey. - View Dependent Claims (51, 52, 53)
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54. A computer system comprising an electronic device, wherein the electronic device comprises a non-transitory computer-readable medium comprising instructions that, when executed by the computer system, cause the computer system to perform:
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analyzing historical validity markers and historical protocol data associated with at least one earlier clinical trial or earlier survey, the historical validity markers comprising; timeliness of a subject response; proximity of data to an expected data range; a number of missed data entry occasions;
ora number of times an entry was changed; generating a predictive algorithm for predicting invalid subject reported data based at least on the analyzing of the historical validity markers and the historical protocol data; translating the predictive algorithm into a decision rule for use with a current clinical trial or current survey, the decision rule specifying an action; and determining that the action should be taken based at least on an application of the decision rule to validity markers associated with the current clinical trial or current survey. - View Dependent Claims (55, 56, 57, 58, 59, 60, 61, 89)
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62. A computer system comprising an electronic device, wherein the electronic device comprises a non-transitory computer-readable medium comprising instructions that, when executed by the computer system, cause the computer system to perform:
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analyzing historical validity markers and historical protocol data associated with one or more earlier clinical trials or earlier surveys, the historical validity markers comprising; timeliness of a subject response; proximity of data to an expected data range; a number of missed data entry occasions;
ora number of times an entry was changed; generating an algorithm based at least on the analyzing of the historical validity markers and the historical protocol data; translating the algorithm into a decision rule for analyzing information on validity of subject response data, the decision rule specifying an action; obtaining validity markers for at least one event associated with a current clinical trial or current survey; applying the decision rule to the validity markers; and determining that the action should be taken based at least on the application of the decision rule to the validity markers for at least one event associated with the current clinical trial or the current survey. - View Dependent Claims (63, 64, 65, 90)
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66. A computer system comprising an electronic device, wherein the electronic device comprises a non-transitory computer-readable medium comprising instructions that, when executed by the computer system, cause the computer system to perform:
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analyzing historical validity markers and historical protocol data associated with one or more earlier clinical trials or earlier surveys, the historical validity markers comprising; timeliness of a subject response; proximity of data to an expected data range; a number of missed data entry occasions;
ora number of times an entry was changed; generating a spectrum of invalidity representative of the historical validity markers not compliant with the historical protocol data based at least on the analyzing of the historical validity markers and the historical protocol data, the spectrum of invalidity specifying a plurality of actions; obtaining validity markers for at least one event associated with a current clinical trial or current survey; and determining that one of the plurality of actions should be taken based at least on a comparison of the spectrum of invalidity to the validity markers. - View Dependent Claims (67, 68, 91)
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69. A computer system comprising an electronic device, wherein the electronic device comprises a non-transitory computer-readable medium comprising instructions that, when executed by the computer system, cause the computer system to perform:
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analyzing historical validity markers and historical protocol data associated with one or more earlier clinical trials or earlier surveys, the historical validity markers comprising; timeliness of a subject response; proximity of data to an expected data range; a number of missed data entry occasions;
ora number of times an entry was changed; generating a fraud detection algorithm for detecting subject fraud based at least on the analyzing of the historical validity markers and the historical protocol data; translating the fraud detection algorithm into a fraud detection rule, the fraud detection rule specifying an action; and determining that the action should be taken based at least on an application of the decision rule to validity markers associated with a current clinical trial or a current survey. - View Dependent Claims (70, 71, 72, 73, 74, 75, 76, 92)
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77. A computer system comprising an electronic device, wherein the electronic device comprises a non-transitory computer-readable medium comprising instructions that, when executed by the computer system, cause the computer system to perform:
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analyzing information on a validity of subject reported data from one or more earlier clinical trials or earlier surveys, the information comprising; timeliness of a subject response; proximity of data to an expected data range; a number of missed data entry occasions;
ora number of times an entry was changed; generating a fraud detection algorithm for detecting subject fraud based at least on the analyzing of the information; translating the fraud detection algorithm into a fraud detection rule, the fraud detection rule specifying an action; and determining that the action should be taken based at least on an application of the fraud detection rule to validity markers associated with a current clinical trial or a current survey. - View Dependent Claims (78, 79, 80, 93)
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Specification