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2016-10-10
Technical guidelines for clinical trial data management

The quality of clinical trial data is the basis of evaluating clinical trial results. In order to ensure the accuracy, reliability and scientific credibility of clinical trial results, a series of regulations, regulations and guiding principles have been issued by the international community and countries around the world to standardize the whole process of clinical trial data management. At the same time, the development of modern clinical trials of new drugs and the continuous progress of science and technology, especially the development of computers and networks, provide new technical support for the standardization of clinical trials and data management, and also promote the governments of various countries and the international community to actively explore new standardized models of clinical trials and data management.

(1) Current situation of clinical trial data management in China

China's good clinical practice (GCP) puts forward some principles and requirements for clinical trial data management, but the regulations and technical provisions on specific data management operation are still in blank. Due to the lack of supporting technical guidelines, the standardization of drug clinical trial data management in China is not high, and the quality of clinical trial data management is uneven, which affects the objective scientific evaluation of the effectiveness and safety of new drugs. In addition, the development and application of electronic data management system in domestic clinical trials is still in its infancy. The data management mode of clinical trials is mostly based on the data collection stage of paper case report form (CRF). The application of electronic data acquisition and data management system needs to be popularized and popularized. At the same time, due to the lack of national data standards, it is difficult to achieve information sharing between similar research databases.