Clinical research SPO quality management method and system based on aPaaS

Abstract

The invention relates to a clinical research SPO quality management method and system based on aPaaS, and belongs to the field of computers. The method comprises the following steps: S1, establishing SPO quality dimension elements of clinical research, namely quality element modules on three dimensions of a structure S, a process P and a result O of a project; s2, constructing an SPO basic database relationship on the aPaaS platform; s3, deploying a localization system of the research center; and S4, integrating the SPO shared data chain set of each project, implementing interactive management, and improving the project quality. The invention relates to a lightweight, simple, convenient, shared and interactive quality management method and system, which can be used for solving the problems that a current clinical research quality management information system is designed by IT personnel of a professional software company, a designer is unfamiliar with a clinical test, software design is complex, operation is tedious, training time is long, updating is troublesome, and efficiency is high. And software price is high, data information is difficult to share, and project management is lagged.

Description

technical field [0001] The invention belongs to the field of computers, and relates to an aPaaS-based clinical research SPO quality management method and system. Background technique [0002] In recent years, management software for various clinical research emerges in an endless stream. In the field of project quality management, major domestic software companies have released various clinical trial management systems (abbreviated as CTMS), clinical research remote monitoring management system (abbreviated as CTRM), clinical trial digital management system (DCT), etc.; Enterprises and CRO companies also have internal quality management monitoring and auditing systems. However, the system design of such software is generally complicated, and it is expensive to purchase or create. The research center has a cumbersome purchase and bidding process. The operation training before promotion and implementation is time-consuming and laborious, and it is often not convenient to use....

AI Technical Summary

Problems solved by technology

However, the general system design of this kind of software is relatively complicated, and it is expensive to purchase or create. The research center has a cumbersome purchase and bidding process. The operation training before promotion and implementation is time-consuming and laborious, and it is often not convenient to use.

[0003] In addition, in the management mode of various clinical research quality management systems currently on the market, most systems conduct process management based on the time axis, especially node time management in various administrative processes; a few systems embed the concept of total quality management , comprehensively set up sub-modules from "human, machine, material, method, and environment" to carry out systematic quality management, but the complexity of the system is greatly increased, and the practicability and applicability of the management system are reduced instead, which is a problem for the research center. of project managers have added a lot of data entry work, it is difficult to effectively improve work efficiency, and it is not easy to promote

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