METHODS FOR CENTRAL MONITORING OF RESEARCH TRIALS

摘要

A method for central monitoring of a research trial utilizing a plurality of distributed data collection centers includes creating and storing a database consisting of datasets generated during the research trial. Statistical tests are executed in the network on a data collection center by data collection center basis to detect abnormalities and patterns present in datasets of the statistical database. A matrix containing p-values based upon the executed statistical tests is created and stored in the network. The matrix has as many rows as there are data collection centers and as many columns as executed statistical tests. Any outlying data collection centers are identified by summarizing the p-values. Data Inconsistency Score (DIS) is created for each collection center.

主权项

1. A method for conducting a research trial utilizing a plurality of distributed data collection centers, the method comprising the steps of:
creating and storing a database consisting of datasets generated during the research trial, wherein each dataset includes a center and corresponding center data; executing statistical tests, by a processor, on a data collection center by data collection center basis to detect abnormalities and patterns present in datasets of the statistical database; creating and storing, by a processor, a matrix containing p-values based upon the executed statistical tests, wherein the matrix has as many rows as there are data collection centers and as many columns as executed statistical tests; identifying, by a processor, any outlying data collection centers by summarizing the p-values; and generating, by a processor, Data Inconsistency Score (DIS) for each center.