CRF monitoring method and device

Abstract

The invention discloses a CRF monitoring method and device, and the method comprises the steps: reading a case report form CRF of a monitored object, and reading a plurality of source data of the monitored object; calculating similarities between the CRF and the plurality of source data; and displaying the plurality of source data in a monitoring area of the monitoring object according to the similarities. Through the technical scheme of the invention, an easy-to-use and efficient CRF monitoring process is constructed, the method can be applied to a database environment of mass data, and the CRF can be efficiently monitored, so that the dependence on CRA capability in the whole process can be reduced, the clinical test cost is further reduced, and the CRF data monitoring efficiency is improved. The technical problem that in the prior art, the CRF data monitoring speed is low, is solved.

Description

technical field [0001] The invention relates to the field of medical data processing, in particular to a CRF monitoring method and device. Background technique [0002] In traditional clinical trials, CRF (case report form, Case report form) monitoring is an important link to ensure the quality of clinical trial data. [0003] After the CRC (Clinical Coordinator, Clinical Research Coordinator) enters the subject's medical record data into the CRF according to the specifications, the CRA (Clinical Monitor, Clinical Research Associate) needs to monitor whether the entered CRF is entered correctly. This double verification The method ensures the quality of the entire clinical trial data. However, in the current monitoring method, the CRA uses manual on-site SDV to compare the CRF and the source data, and a lot of time is spent on searching the original medical records and comparing whether they are consistent with the CRF. The traditional manual monitoring method has the foll...

AI Technical Summary

Problems solved by technology

However, in the current monitoring method, the CRA uses manual on-site SDV to compare the CRF and the source data, and a lot of time is spent on searching the original medical records and comparing whether they are consistent with the CRF

The traditional manual monitoring method has the following two serious problems: the efficiency of CRA to search medical records is low, and if the amount of clinical trial data is large, it is difficult for CRA to complete the monitoring of all data within a limited time, and the bottleneck of monitoring efficiency is obvious

The CRA manual inspection method requires search and comparison in a large range of data, so human errors are inevitable

[0004] Aiming at the above problems existing in the prior art, no effective solution has been found yet

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