A system for developing and implementing empirically derived algorithms to
generate decision rules to determine participant noncompliance and fraud
with research protocols in clinical trials allows for the identification
of complex patterns of variables that detect or predict participant
noncompliance and fraud with research protocol, including performance and
enrollment goals, in the clinical trial. The data may be used to overall
predict the performance of any participant in a clinical trial, allowing
selection of participants that tend to produce useful, high-quality
results. The present invention can also be used to monitor participant
compliance with the research protocol and goals to determine preferred
actions to be performed. Optionally, the invention may provide a spectrum
of noncompliance, from minor noncompliance needing only corrective
feedback, to significant noncompliance requiring participant removal from
the clinical trial or from future clinical trials. The algorithms and
decision rules can also be domain-specific, such as detecting
non-compliance or fraud among subjects in a cardiovascular drug trial, or
demographically specific, such as taking into account gender, age or
location, which provides for algorithms and decision rules to be
optimized for the specific sample of participants being studied.