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 improving compliance within at least one clinical study at a clinical trial site using an analytical device having a processor, the analytical device being networked to clinical information technology (IT) infrastructure, the clinical IT infrastructure including a clinical workflow management system, comprising:
obtaining, by the analytical device, at least one protocol for the clinical study by accessing a clinical study standard operating procedure (SOP) information from a first database; extracting, from said first database, a list of work-oriented quality regulations that includes weighting factors indicating a weight given to an associated one of the quality regulations based on a correlation between the associated quality regulation and an increase in the compliance with the at least one clinical study provided therefrom, and forming said quality regulations including the weighting factors into a second database for quality-related rules for a clinical workflow; linking, by said analytical device, enrolled patient identifications (IDs) with said second database; planning, by said analytical device in conjunction with the clinical workflow management system, if a patient is enrolled in the second database, a plurality of clinical actions in compliance with criteria obtained from the clinical study standard operating procedure (SOP) information of said first database and/or from the quality-related rules for the clinical workflow established in said second database; and deleting volatile clinical data generated during execution of the clinical actions upon determining a correlation between the volatile clinical data and the criteria.