Operation and method for prediction and management of the validity of subject reported data

摘要

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.

主权项

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.