Today we would like to speak about clinical trial data validation in the current remote working environment. Yulia Komarova, head of data management at X7 Research, will talk about centralized data monitoring of clinical trials.
Centralized data monitoring – is an integral part of the data management process in clinical trials, which is an effective way to ensure data quality. In fact, centralized monitoring is a remote evaluation of data conducted remotely, not directly in the trial center.
Data collected in clinical trials during centralized monitoring are tested for consistency, coherence, and consistency using a variety of tests and statistical analysis methods, using IT solutions to handle virtually any volume of data.
With centralized monitoring, not only can the completeness and correctness of the data obtained be verified, but also an understanding of the cleanliness of the data input can be formed using various metrics. Since periodic centralized monitoring allows the early detection of abnormal data trends, the patterns found can subsequently be used as an aspect for decision-making in a risk-based monitoring approach.
According to Guidance for Industry, the FDA encourages the broader use of centralized monitoring methods. Of course, this approach cannot replace the reconciliation of data with primary documentation, but it can significantly reduce the time needed for on-site monitoring. In the current epidemiological situation, centralized monitoring is a powerful tool for performing remote verification of information, ensuring the three main characteristics of clinical trial data: truthfulness, integrity, and quality.
X7 Research’s data management department, in today’s challenging environment, continues to function as usual. Thanks to the company’s streamlined operating procedures, work on projects continues to meet deadlines and maintain quality.