Method and system for measuring quality of performance and/or compliance with protocol of a clinical study

摘要

A method is proposed for determining clinical study compliance. The method includes obtaining criteria for the clinical study and accessing stored clinical data relating to the clinical study. Thereafter, the criteria and clinical data are correlated to determine a measure of compliance with the criteria of the clinical study.

主权项

1. A method of analyzing quality of a clinical study by an analytical device including a processor, a memory and a networking interface, the method comprising:
creating, by the analytical device, a database including quality related aspects from criteria for the clinical study; accessing, by the analytical device, stored clinical data relating to the clinical study, the clinical data including volatile clinical data that is entered for a short time and thereafter subsequently deleted; correlating, by the analytical device, the quality related aspects of criteria and clinical data to determine performance of the quality related aspects of the criteria of the clinical study, the correlating of the criteria and the clinical data including attempting to correlate the volatile clinical data with the criteria for the clinical study; permanently storing, by the analytical device, the volatile data upon determining a lack of correlation between the volatile clinical data and the criteria such that the volatile clinical data is transformed into non-volatile clinical data; and deleting the volatile clinical data upon determining a correlation between the volatile clinical data and the criteria.