ENHANCED MONITORING
First Claim
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1. A system for monitoring a clinical trial, comprising:
- a data input terminal, the data input terminal located at a data collection point and comprising a plurality of input validation rules, the data input terminal receiving data from a user, the data having a datatype, and applying at least one of the plurality of input validation rules to the data;
a first datastore receiving data from the data input terminal;
a data analysis server comprising;
a plurality of data validation rules, the server receiving the data from the first datastore and applying at least one of the plurality of data validation rules to the data to obtain a result;
a plurality of triggers, the server initiating at least one of the triggers based on the result of the application of the at least one of the plurality of data validation rules.
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Abstract
The presently disclosed subject matter provides for efficient and effective monitoring, while eliminating practices that may not be of value in assuring human subjects protection and reliable and informative study results. The present disclosure provides methods, computer program products, and systems for data collection and validation for Enhanced Monitoring (EM). The Enhanced Monitoring model disclosed herein increases productivity and efficiency by decreasing the frequency of on-site monitoring visits and employing remote review techniques to focus on the process as compared to individual data points.
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Citations
17 Claims
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1. A system for monitoring a clinical trial, comprising:
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a data input terminal, the data input terminal located at a data collection point and comprising a plurality of input validation rules, the data input terminal receiving data from a user, the data having a datatype, and applying at least one of the plurality of input validation rules to the data; a first datastore receiving data from the data input terminal; a data analysis server comprising; a plurality of data validation rules, the server receiving the data from the first datastore and applying at least one of the plurality of data validation rules to the data to obtain a result; a plurality of triggers, the server initiating at least one of the triggers based on the result of the application of the at least one of the plurality of data validation rules. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method of validating clinical data comprising:
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reading a plurality of rules from a rulebase; reading input data, the input data comprising a plurality of values; applying the plurality of rules to the input data to determine an indicator for each of the values, the indicator for each of the values indicating whether the value is erroneous; based on the indicators for each of the values, initiating at least one trigger. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16)
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17. A computer program product for monitoring of clinical data, the computer program product comprising a computer readable storage medium having program code embodied therewith, the program code executable by a processor to:
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read a plurality of rules from a rulebase; read input data, the input data comprising a plurality of values; apply the plurality of rules to the input data to determine an indicator for each of the values, the indicator for each of the values indicating whether the value is erroneous; based on the indicators for each of the values, initiate at least one trigger.
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Specification